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1.
Laryngo- Rhino- Otologie ; 101:S307, 2022.
Article in English | EMBASE | ID: covidwho-1967677

ABSTRACT

Introduction As part of the immune response to the COVID-19-vaccine a multitude of anti-COVID-antibodies is formed. A part of these antibodies can bind to the body-s own tissue and facilitate autoinflammatory processes. Such autoimmune-inflammatory processes are suspected to be behind various symptoms of the COVID disease and the long-COVID syndrome. So far, numerous reports on neuro-otological symptoms in the context of COVID infection have been published. The present report describes patients who presented in a university ENT outpatient department with vestibulo-cochlear symptoms in connection with a COVID vaccination. Methods All patients who presented with dizziness, tinnitus and hearing impairment for the first time in a direct temporal context (max. 3 days after vaccination) tot he vaccination were examined by an ENT specialist and further examined using subjective and objective audiometry and, depending on the symptoms, using vestibular diagnostics. Results An otitis media was not found in any patient. A cochlear genesis of the vestibulo-cochlear symptoms could be demonstrated in all patients. One patient has isolated symptoms with hearing loss, all others also suffered from tinnitus or dizziness. In all patients, the symptoms resolved after drug therapy was carried out. Discussion Vaccine-associated hearing loss has also been described in the case of influenza vaccination. We were unable to provide direct evidence of the COVID vaccination as the triggering factor for the vestibulo-cochlear symptoms. An association of these symptoms with the vaccination cannot be ruled out though. The most likely mechanism is an immunoglobulin-triggered specific autoimmune response.

2.
Radiotherapy and Oncology ; 170:S997, 2022.
Article in English | EMBASE | ID: covidwho-1967470

ABSTRACT

Purpose or Objective The dermal recall phenomenon is an increase in the sensitivity of stem cells in the area of the treatment field and may lead to increased acute toxicity. Afterwards, the recall effect has been described in those patients who have been vaccinated against COVID during radiotherapy treatment. Our objective has been to observe if we are facing a dermal recall phenomenon after the administration of the vaccine in patients who are on the course of radiotherapy. Materials and Methods Coinciding with the vaccination campaign against SARS-CoV-2 in oncological patients, which began in our environment in March 2021, we have collected data on radiodermatitis that have been presented by 42 patients after the end of radiation therapy treatment for breast cancer Results The percentage of patients vaccinated were as follows: 57% (24/ 42 patients) Of which 6/24 patients received the vaccine dose during radiation therapy Of the 42 patients treated with radiation therapy, 3 had a degree 3 dermal toxicity. These 3 patients were given the vaccine during radiotherapy treatment, which accounts for 50% of the patients vaccinated during radiotherapy. Note that of the 845 patients treated with hypofractionation radiotherapy since 2016 only 0.23% have presented grade 3 acute radiodermatitis, versus 7% of the patients who have been vaccinated during radiotherapy Conclusion We estimate that most likely, the vaccine carries a greater risk of skin toxicity mediated by the dermal recall phenomenon but that does not mean that the administration of the vaccine should be contraindicated, but more closely warn patients who receive the vaccine during radiation therapy.

3.
Gastroenterology ; 162(7):S-1280, 2022.
Article in English | EMBASE | ID: covidwho-1967447

ABSTRACT

Introduction: Solid organ transplant recipients have 2-5 times increased mortality after coronavirus disease 2019 (COVID-19) infection as compared to general population. These patients also have lower protection after vaccination against COVID-19. Therefore, the risk of breakthrough infection and hospitalization are also significantly higher in this patient population. Studies on efficacy of COVID-19 vaccination in post liver transplant (LT) patients are limited. We aimed to investigate the rate of mortality, hospitalization, and breakthrough infection and assess possible risk factors in COVID-19 infection mortality post LT. Methods: A retrospective chart review study. All post liver transplant patients at Carolinas Medical Center (CMC) who were tested positive for respiratory syndrome coronavirus 2 (SARS-CoV- 2) PCR test from Dec. 2020 (when first COVID-19 vaccine was approved in the US for emergency use authorization) until Nov. 2021 were included in this study. Breakthrough infection was defined as COVID-19 infection ≥14 days after full vaccination. Data was analyzed using Prism (GraphPad Software, San Diego, CA) and reported as mean ± SEM. T- test and chi square tests were applied for analyzing the data. Results: Thirty-six patients were identified and 66.1±9.6 months post liver transplantation (LT). Mean age was 61.2±1.6 years-old, male (72.2%) and Caucasian (91.6%). Ten patients (27.7%) expired. Chronic kidney disease (CKD) was present in 70.0% of expired patients as compared to 53.3% of recovered (p=0.0003). Type 2 diabetes (T2DM) was present in 70.0% vs. 25.0% of expired and recovered patients, respectively (p<0.0001). Hypertension (HTN) was present in 90.0% vs. 55.0% of expired and recovered patients, respectively (p<0.0001). No statistically significant difference was observed in weight of expired vs. recovered patients (50% vs. 65% obesity;p=0.4). Only 9 patients were vaccinated. Breakthrough infection rate was 25% and 2/9 (22.2%) died vs. 29.6% of non-vaccinated patients (p=0.4). COVID-19 infection occurred 4.9±0.86 months after vaccination. Hospitalization (44.4% vs. 55.5%) and ICU admission (22.2% vs. 37.0%) was not statistically different among vaccinated and non-vaccinated patients. Conclusion: T2DM and CKD were significantly higher among COVID-19 infected patients who expired, which are similar risk factors in patients who have not had a liver transplant. However, obesity was not significantly correlated with mortality as it was shown before in non-immunocompromised population. Although COVID-19 vaccine is effective in post LT patients, larger studies are warranted to evaluate its efficacy in this population. Our study also highlights that the efficacy of current COVID-19 vaccines decreases in 4-6 months after full vaccination, which warrants evaluating the efficacy of booster dose(s) in post LT patients

4.
Gastroenterology ; 162(7):S-1253, 2022.
Article in English | EMBASE | ID: covidwho-1967443

ABSTRACT

Introduction. Solid organ transplant recipients were excluded from the pivotal clinical trials of COVID-19 vaccines. Therefore, the safety and efficacy data of the different types of available vaccines in this susceptible population is scarce. The goal of the present analysis was to evaluate the humoral response to the COVID-19 vaccines in orthotopic liver transplant (OLT) recipients. Methods. Participants were included from February to September 2021. No prioritized vaccination was performed for OLT patients, and they were included in the regular schedule according to age and place of residency. Controls were otherwise healthy people, mainly family members of patients. All subjects completed the full vaccination schemes, and blood samples were taken after at least 15 days of the complete vaccine doses. The samples were analyzed according to the manufacturer instructions using Liaison XL platform from DiaSorin, LIAISON® SARS-CoV-2 S1/S2 IgG (DiaSorin S.p.A., Italy), and SARS-COV-2 IgG II Quant (COV-2 IgG II) (Abbott Diagnostics, IL, USA). Results. In all, 187 participants (133 OLT, 54 controls, median age: 60 years, 58.8% women) were included for the analysis;74.3% had at least one comorbidity (31.6% had hypertension, 32.6% diabetes, 7% neoplasia, and 23% obesity). By vaccine brands, 50.3% received Pfizer-BioNTech, 13.9% received Oxford-AstraZeneca, 10.7% received Sinovac, 7.0% Cansino;16% Sputnik-V and 2.1% received Moderna. The serologic response in OLT patients was lower than in controls (median 549 AU/mL vs. 3450 AU/mL, respectively;p 0.001). A positive humoral response was found in 133 OLT individuals: 89.2% with Pfizer-BioNTech, 60% Oxford-AstraZeneca, 76.9% Sinovac, 55.6% Cansino, 68.2% Sputnik-V, and 100% with Moderna. In controls, only Cansino had a 75% humoral response;all other vaccines had a 100% response. In a multivariable model adjusted for relevant confounders, the antecedent of COVID-19 and Pfizer-BioNTech inoculation were associated positively with the serologic response, while the use of prednisone (compared with other immunosuppressants) interfere with this response. Conclusion. The serologic response to COVID-19 vaccines in OLT patients is lower than otherwise healthy controls. In these patients, the Pfizer-BioNTech vaccine was associated with a higher serologic response. Other variables significantly associated with the humoral response were the COVID-19 antecedent (positively) and prednisone exposure (negatively). At the moment, further analysis is necessary to determine whether this serological response is associated with SARS-COV2 infection or reinfection. (Figure Presented)

5.
Gastroenterology ; 162(7):S-1250, 2022.
Article in English | EMBASE | ID: covidwho-1967436

ABSTRACT

Background: The 2019 novel coronavirus (COVID-19) has been associated with elevated liver enzymes, which has seen to be associated with a higher mortality rate in COVID-19 infected patients. With a global vaccination rate under 50%, as of November 2021, we will continue to see patients admitted for COVID-19 infection. We have done this study to further evaluate the relationship between development of transaminitis and its relation to vaccination status and to see if vaccination prevented liver injury in COVID-19 patients. Methods: A retrospective study was performed between October 2019 and October 2021 on patients infected with COVID-19. A total of three hundred and fifty patient charts were included in the study. Patient data regarding age, sex, comorbidities, vaccination status, vaccine manufacturer, mortality, and length of stay data were reviewed. Patients were then divided into two groups (Vaccinated vs Unvaccinated ), data was then matched for their age, sex, and comorbidities using propensity score matching. Results: Each group had thirty-nine patients after propensity score matching. The average age in both groups was 58.4±13.3. Twenty-one females were in a non-vaccinated group and twenty females in the vaccinated group. The average number of days to infection from the last COVID-19 vaccine was 132±57. The vaccinated group showed a significant reduction in the incidence of liver injury with respect to AST (42±13 vs. 93.3±35, P< 0.02, 95% CI), ALT (50±10 vs. 97.4±45.5 P<0.04), and ALP 65±15.2 vs. 93±35.6 P<0.01) compared to unvaccinated patients. The vaccinated patient group showed a reduced length of stay compared to the unvaccinated group ( 10.6 ± 4.8 vs. 18.1 ± 8.1, P<0.05). The vaccinated patient group showed a decrease in mortality as compared to the unvaccinated group (17 vs. 8, P<0.05). Conclusion: After a thorough review of COVID infected patients, liver enzyme abnormalities were evaluated in vaccinated and unvaccinated patients. ALT, AST, and ALP in vaccinated patients were found to be significantly lower in as compared to unvaccinated patients. Hospital length of stay and mortality rate were both found to be lower in vaccinated patients compared to unvaccinated patients. Recent vaccination status leading to decreased infection severity may relate to the lack of significant and dramatic increase in liver enzyme levels and may present as confounding factors. Major limitation in the study was the small sample size and future studies with a larger sample size can deliver a better perspective.

6.
Gastroenterology ; 162(7):S-1248, 2022.
Article in English | EMBASE | ID: covidwho-1967431

ABSTRACT

commonly worldwide but their effectiveness in participants with cirrhosis is unknown. We explored the effectiveness of vaccination with the Janssen Ad.26.COV2.S compared to the mRNA Pfizer BNT162b2 or Moderna 1273-mRNA vaccine in participants with cirrhosis. Method: This was a test-negative case control study among participants with cirrhosis. This study design is widely used in evaluations of vaccine effectiveness and has the advantage of minimizing biases associated with access to vaccination or health care. Cases were those who were SARS CoV2 PCR positive, controls were those who tested negative during the study period between March 15, 2021 and October 3, 2021. Participants who did not undergo SARS CoV2 PCR testing, who had COVID-19 before the study period, or received a liver transplant, were excluded. COVID-19 was classified based on individual chart review using the National Institute of Health (NIH) COVID-19 severity scale as asymptomatic, mild, moderate, severe or critical illness. Propensity score matching was used to match test positive cases and test negative controls. The propensity score of having COVID-19 were derived from a logistic regression that adjusted for the participant's sex, age, date of testing, race/ethnicity, location, alcohol as the etiology of liver disease, body mass index (BMI), diabetes mellitus, current tobacco use, current alcohol use, co-morbidities, and the Child Turcotte Pugh score. Multinomial logistic regression models were fit for COVID-19, to assess the adjusted effect from vaccination with either the Ad.26.COV2.S or the mRNA-1273 or BNT162b2 vaccines. Results: A total of 955 cases and 955 matched controls were included in the study population. The two groups were well matched to all baseline characteristics. The Ad.26.COV2.S vaccine had an effectiveness of 64% against COVID-19 (adjusted Odds Ratio [aOR] 0.36, 95% CI 0.20-0.62, p=0.005). Effectiveness was lowest with asymptomatic illness (aOR 0.42, 0.18-0.73, p=0.03), and higher against mild (aOR 0.36, 0.15-0.63, p= 0.006), moderate (aOR 0.33, 0.14-0.49, p=0.002) and severe/critical (aOR 0.24, 0.08-0.83, p=0.04) COVID-19. In the same period, mRNA vaccines had a 73% effectiveness against overall COVID-19 (aOR 0.27, 0.19-0.37, p<0.0001), progressively higher from asymptomatic (aOR 0.38, 0.23-0.59, p=0.0004) to mild (aOR 0.29, 0.18-0.42, p<0.0001), moderate (aOR 0.27, 0.18-0.36, p<0.0001), and severe or critical illness (aOR 0.17, 0.06-0.32, p<0.0001). There were no statistically significant differences between the viral vector and mRNA vaccines. Conclusion: In participants with cirrhosis, the Ad.26.COV2.S demonstrated a 64% effectiveness against COVID-19, and a 74% effectiveness against severe or critical COVID-19, similar to that associated with mRNA vaccines. (Figure Presented)

7.
Gastroenterology ; 162(7):S-1247-S-1248, 2022.
Article in English | EMBASE | ID: covidwho-1967430

ABSTRACT

Introduction COVID-19 vaccines have been shown to be effective in preventing hospitalization due to COVID-19 infection. However, safety remains a concern. Some studies have linked the vaccine to the development of autoimmune diseases such as myocarditis and immune thrombocytopenic purpura. During the summer of 2021, an increasing number of case reports began to emerge documenting a small number of individuals who developed autoimmune hepatitis (AIH) following COVID-19 vaccination. These cases are rare, novel, and very little is known. In our systematic review, we analyzed every published case of AIH and reviewed their characteristic findings, treatment, and outcomes. Methods We searched PubMed, Embase, and Web of Science from 1 December 2019 to 1 November 2021. Keywords included but were not limited to “COVID-19,” “vaccine,” and “autoimmune hepatitis.” Two researchers independently extracted information from the articles about vaccine type, patient history, characteristics, laboratory values, histology results, treatment regimens, and disease course. Results Thirty-two patients developed AIH after receiving a COVID-19 vaccine (16 Pfizer-BioNTech, 13 Moderna, 3 Oxford-AstraZeneca), of whom 17 were from the United States, 11 were from Europe, 3 were from Asia, and 1 was from Australia. Sixty-nine percent of patients were women and 58% had no history of liver or autoimmune disease. Jaundice was the most common symptom (81%). Nineteen percent of patients were initially asymptomatic and presented with abnormal liver enzymes found during routine bloodwork. (Table 1) Mean ALT, AST, and bilirubin were 1231 U/L, 921 U/L, and 14 mg/dL. Anti-nuclear antibody and anti-smooth muscle antibody were positive in 56% and 28% of patients. Liver biopsy was performed in 81% of patients with findings strongly suggestive of AIH. Corticosteroids were used in 74% of patients with a mean time to disease resolution of 28 days. Improvement or complete resolution was seen in 97% of patients. (Table 2) One patient died despite aggressive steroid treatment. Discussion COVID- 19 vaccine-induced AIH is extremely rare with just 32 documented cases in the literature. Although causality cannot be proved, this phenomenon should not be treated as coincidence. Clinicians should be aware of this rare but real complication and suspect vaccine-induced AIH in patients who present with jaundice and abnormal liver enzymes following COVID- 19 vaccination. Treatment with corticosteroids appears to be highly effective, with improvement or resolution in 97% of patients. Our findings highlight the rarity of COVID-19 vaccine-induced AIH and should under no circumstances deter individuals from getting vaccinated as the benefits of vaccination far outweigh the risks. (Table Presented)

8.
Gastroenterology ; 162(7):S-1246-S-1247, 2022.
Article in English | EMBASE | ID: covidwho-1967427

ABSTRACT

Introduction: Exacerbation of pre-existing autoimmune disease and de novo vaccine-related autoimmunity after SARS-CoV-2 vaccine has been reported. These observations could lead to vaccine hesitancy among autoimmune hepatitis (AIH) patients. We aimed to assess hesitancy as well as prevalence of flare and disease onset after vaccination in an online AIH cohort. Methods: Electronic invitation to complete a vaccine-specific questionnaire was posted weekly to the Autoimmune Hepatitis Association (www.aihep.org) social media communities (membership: 4700) over 3-weeks. Individuals 18 years or older with AIH diagnosis made by a physician were eligible. Vaccine hesitancy was defined as not receiving SARS-CoV-2 vaccine. AIH flare was defined as abnormal liver tests, when previously normal for 1 year, requiring escalation of immunosuppression within 2 months of SARS-CoV-2 vaccine. Continuous variables were summarized as means and standard deviations and pvalues were obtained using the Student's T-test. P-values for discrete variables were obtained from the Chi-Square test. The study was approved by local institutional review board. Results: A total of 643 individuals, 91.9% female, 91.8% white, mean age of 54 years and disease duration of 7 years, completed the questionnaire. A majority (599, 93.2%) had received at least 1 dose of vaccine including Pfizer-BioNTech (50.2%), Moderna (35.2%), AstraZeneca (11.1%), and Johnson & Johnson (3.5%). Hesitant patients were less likely female (79.5% vs 92.8%), younger (48 vs 55 years) and had higher prevalence of COVID- 19 infection (27.3% vs 10.2%) compared to vaccinated (p < 0.005 for all). Among those eligible, 95.3% received a second dose and 53.7% a third dose. Five patients did not receive a second vaccine dose because of prior adverse reactions or liver test elevations. A third dose was not administered to 263 patients because it was too early (57%), patient choice (21%), adverse side effects (9%), initial vaccine was Johnson & Johnson (7%), or abnormal liver tests (6%). Among those with normal liver tests prior to vaccination, 5% (15/288) reported increased tests after first or second dose. Liver test elevations were more likely in non-white (67% vs 95%, p = 0.001) and Hispanic/Latino patients (27% vs 4%, p = 0.001) compared to those without elevations. Only 2 patients had disease flare after first dose, whereas no AIH flares were reported after second. New diagnosis of AIH was reported 2 months beyond vaccination in 7% of vaccinated patients (42/599): 16 after first dose and 26 after second dose. Conclusion: SARS-CoV-2 vaccine hesitancy among AIH patients was minimal compared to the national average. Reports of liver test elevation and disease flare were rare after vaccination. New AIH diagnosis near vaccine was reported, yet new diagnosis was also observed in vaccine hesitant patients. (Table Presented)

9.
Gastroenterology ; 162(7):S-1169, 2022.
Article in English | EMBASE | ID: covidwho-1967421

ABSTRACT

Introduction: Perinatal infection with Hepatitis B virus (HBV) becomes chronic in 90% of cases with subsequent risk of developing serious liver disease. To prevent this, American Academy of Pediatrics has set recommendations for 3 groups of newborns weighing $ 2,000 grams: (1) maternal Hepatitis B surface antigen (HbSAg) negative: administration of HBV vaccine by 24 hours of life (HoL);(2) maternal HbSAg unknown: administration of HBV vaccine by 12 HoL (and HBV immune globulin by hospital discharge if status remains unknown);and (3) maternal HbSAg positive: administration of HBV vaccine and immune by 12 HoL. These timings maximize effectiveness of the HBV vaccine in preventing vertical transmission. Given poor compliance with current HBV vaccination demonstrated by the National Immunization Survey, this study aims to better understand factors associated with vaccine implementation at a large women's and children's center during the SARS-CoV-2 pandemic. Methods: This study was a retrospective chart review of newborns born from January 2019-September 2021 at Texas Children's Hospital in Houston, Texas (n=17,294). All newborns$2,000 grams were included and stratified by maternal HbSAg result (negative, unknown, or positive by 12 HoL) (see Figure). Univariate analysis was used to identify factors associated with timely receipt of the HBV vaccine and/or HBV immune globulin. Results: In the group with negative maternal HbsAg (n=17,185), 70.3% (n=12,077) received the HBV vaccine by 24 HoL. Those not receiving the vaccine prior to discharge (6.9%, n= 1,180) were more likely to be Caucasian, have commercial insurance, and not receive vitamin K or erythromycin. In the group with unknown maternal HbSAg (n=74), 17.6% (n=13) received the HBV vaccine by 12 HoL while 75.7% (n=56) received it between 12 HoL and discharge. In the group with positive maternal HbSAg (n=35), 91.4% (n=31) received the HBV vaccine and immune globulin by 12 HoL. Overall deviation from vaccination guidelines was highest in newborns admitted to intensive care units, and similar vaccination rates occurred in the period before and during the SARS-CoV-2 pandemic. Conclusions: Newborn HBV vaccination practices are not meeting American Academy of Pediatrics recommendations, which suggests a need to reevaluate current hospital protocol. Given that newborns with maternal HBV positive or unknown status are at highest risk of vertical transmission, initial interventions to improve timely vaccination should target these groups first, especially in intensive care settings. While 30% of newborns born to HbSAg negative mothers were not vaccinated by the recommended 24 HoL, only 7% had not received HBV vaccination prior to discharge. Dialog to increase HBV vaccine acceptance with individual families will likely be required to improve these rates. (Figure Presented)

10.
Gastroenterology ; 162(7):S-1138, 2022.
Article in English | EMBASE | ID: covidwho-1967413

ABSTRACT

Background There is limited data on the efficacy of SARS-CoV-2 vaccinations on the immunosuppressed population—especially in the liver transplant (LT) population. A study in Israel found that only 47% of LT recipients developed adequate antibodies against the virus while another study in Baltimore, MD found an immune response of 81%. Moreover, early studies in San Diego, CA and Miami, FL on the outcomes of COVID-19 disease among solid organ transplant recipients showed reductions in symptomatic disease of 75 to 80%. We aim to identify the incidence and outcomes of COVID-19 disease in fully vaccinated LT recipients in a large cohort of LT recipients. Methods In a large integrated healthcare system in Southern California with a population of 4.3 million active members aged 18 or older, data was extracted from the electronic health record (EHR) and transplant registry. COVID-19 disease was identified by a positive polymerase chain reaction (PCR) test for SARS-CoV-2. We defined fully vaccinated as 14 days after the 2nd dose of Pfizer or Moderna vaccines or after the 1st dose of Johnson and Johnson vaccine. Chi square analysis was used to compare the difference between 2 groups. Results We identified 1271 active members who had received a LT as of 12/1/2021. Among LT recipients, 90.6% (1152/1271) had received at least one dose of a COVID-19 vaccination, 89.1% (1132/1271) were fully vaccinated, and 58.6% (745/1271) had received booster vaccinations. Between 3/1/20 and 11/30/21, 172 (13.5%) LT recipients had been infected with COVID-19 disease, of which, 37 (3.3%) were infected after being fully vaccinated. Of those infected after being fully vaccinated, 38.9% (15/37) were female. The mean age was 58.7 ± 9.8. 62.2% had diabetes, 73.0% had hypertension, and the mean body mass index (BMI) was 29.3 ± 5.8. 24.3% (9/37) were hospitalized for COVID-19-related illness. The case fatality of COVID-19 was 2.7% (1/37) in post-vaccinated LT recipients compared with 7.4% (10/135) who were unvaccinated prior to infection (OR 0.35, 95% CI 0.04-2.80, p = 0.27). The patient who passed away from COVID-19 after vaccination (diagnosed 4 months after receiving the second dose) had chronic kidney disease and obesity (BMI 42). Conclusions In our large cohort of LT recipients, a significant proportion were fully vaccinated, and the majority had received a booster vaccination dose. A small proportion of LT recipients were infected with COVID-19 disease after being fully vaccinated for COVID-19. The case fatality rate, although not statistically significant, of patients infected post-vaccination was lower compared to unvaccinated patients. More research is needed on the long-term outcomes of COVID-19 and vaccine efficacy in this high-risk population.

11.
Gastroenterology ; 162(7):S-1137, 2022.
Article in English | EMBASE | ID: covidwho-1967412

ABSTRACT

Background and Aims: Immunity to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can be either infection-induced or vaccine-induced. The duration of protective immunity following SARS-CoV-2 infection and how this compares with that from vaccination is presently unclear. Cirrhosis is associated with vaccine hyporesponsiveness to several vaccines include COVID-19 mRNA vaccines. The objective of our study was to compare infection-induced and vaccine-induced immunity against COVID-19 among patients with cirrhosis. Methods: This was a retrospective cohort study among patients with cirrhosis. Vaccine-induced immunity group was defined as participants with cirrhosis who were fully vaccinated with an mRNA vaccine and received the first dose of the mRNA vaccine between 12/18/2020 and 4/1/2021. Infection-induced immunity was defined as participants who had their first positive SARS-CoV-2 PCR in the same study period. The outcome was a positive SARS-CoV-2 PCR more than 60 days after previous infection or vaccination. Patients were followed until the outcome, death or the end of the study period (11/16/21). COVID-19 cases were classified based on individual chart review using the National Institute of Health (NIH) COVID-19 severity scale as asymptomatic, mild, moderate, severe or critical illness. The two groups were matched 1:3 using propensity score (PS) matching, with PS scores calculated based on variables associated with COVID-19 severity, including for the date of infection or first dose of vaccnation, and location, to account for variants. Cox proportional hazards models were fit from the immunity generating event to outcome (SARS-CoV-2PCR). Logistic regression models were also fit for the outcome (positive SARS-CoV-2 PCR) after the immunity generating event. Results: There were 443 participants in the infection-induced group, that were PS matched with 1,329 participants in the vaccine-induced group. The two groups were well matched after PS matching. On multivariable Cox hazard model, vaccine-induced immunity was associated with a 75% reduction in COVID-19 compared to infection-induced immunity (adjusted Hazard Ratio 0.25, 95% CI 0.15-0.43, p<0.0001). On multinomial logistic regression analysis, vaccine-induced immunity was associated with a 80% reduction in asymptomatic (adjusted Odds Ratio [aOR] 0.20, 95% CI 0.09-0.47, p-0.0002), 64% reduction in mild (aOR 0.36, 95% CI 0.13-0.97, p=0.048), and 79% reduction in severe or critical COVID-19 (aOR 0.21,95% CI 0.06-0.74, p=0.02) compared to infection-induced immunity. There were no observed differences between the two groups for moderate COVID-19 (aOR 0.31, 95% CI 0.06-1.56, p=0.16). Conclusions: In participants with cirrhosis, vaccine-induced immunity is associated with a significantly greater protection against COVID-19 compared to infection-induced immunity.[Figure Presented]

12.
Gastroenterology ; 162(7):S-1082, 2022.
Article in English | EMBASE | ID: covidwho-1967407

ABSTRACT

Background: Real-world population-based safety data about the COVID-19 mRNA vaccine is lacking in patients with various immunocompromised conditions, including inflammatory bowel disease (IBD). Aim: To determine the incidence rates of unplanned IBD-related hospital admission and all-cause emergency attendance following BNT162B2 vaccination in IBD patients. Methods: Through the Government commissioned, territory-wide active COVID19 safety surveillance, we linked population-level vaccination records and health outcome data, between March 10 (1st day of vaccination program) and September 30, 2021, to assess the association between two-dose of BNT162b2 and unplanned IBD-related hospitalization and all-cause emergency attendance. We used inverse probability treatment weightingbased cohort study design to balance the baseline characteristics between vaccinated and unvaccinated IBD patients. Poisson regression model was fitted to estimate the adjusted incidence rate ratio (IRR) of unplanned IBD hospital admission and 28-day emergency room attendance following the vaccination, using the unvaccinated group as the reference. Results: Among more than 4.1 million citizens with successful vaccine and health record-linkage, we identified 941 IBD patients (age: 46.0 ± 15.0 years, male: 64.2%) who completed twodose of BNT162b2 and 1196 age-sex matched unvaccinated IBD patients as control (age: 49.3 ± 18.3 years, male: 58.9%). After inverse propensity weighting, all baseline demographic and clinical characteristics were well balanced (standard mean difference < 0.1;Table 1). During a median follow-up of 59-60 days (181.2 person-years for BNT162b2 group;253.6 person-years for the unvaccinated group), there was no significant difference in the risk of unplanned IBD-related hospital admission [3.31 versus 5.13 per 100 person-years, IRR: 0.75 (0.38, 1.47)] and 28-day all-cause emergency room attendance [39.1 vs 47.5 per 100 person-years, IRR: 1.08 (0.76-1.53)] between BNT162b2 recipients and unvaccinated individuals. Series of stratified analyses, including patients with Crohn’s disease (N= 378) or ulcerative colitis (N=553), who received immunosuppressants (N=454) or biologics (N= 192), all showed that receiving two-dose of BNT162b2 vaccine was not associated with a higher risk of unplanned IBD-admission and 28-day emergency attendance when compared to their counterparts without vaccination (Figure 1). Conclusion: Results from this populationbased study showed no increase in risk of unplanned IBD-related hospitalization and allcause emergency attendance following two-dose of BNT162b2 Covid-19 vaccination in patients with IBD. This observation potentially reassures the medium-term safety of mRNA vaccine in patients with IBD, although there is still possible self-selection bias in receiving the vaccine. (Table Presented) (Figure Presented)

13.
Gastroenterology ; 162(7):S-1081-S-1082, 2022.
Article in English | EMBASE | ID: covidwho-1967406

ABSTRACT

Background Data about the effect of different immunosuppressive treatments of IBD patients on seroconversion and to different SARS-CoV-2 vaccinations are scarce. To avoid impaired vaccine responses and worse outcome of COVID-19, factors attenuating protective immunity shoud be shought. Methods Anti SARS-CoV-2S antibody levels of IBD patients in remission were measured by immunoassay (Roche) before vaccination and on the second week. Antibody responses were compared among different treatment groups (biologics, combination, azathioprin, without immunomodulation) and between mRNA and other type of vaccines. Anti TNF alpha levels were also assesed 24 hours before vaccination considering correlation with seroconversion. Results Thirty-eight (31.7%) ulcerative colitis and eightytwo (68,2%) Crohn’s disease patients were included (median age 39.1 years, 53.3% female). No serious comorbidities were present. Eighty-two patients (68.3%) were on biological therapy, fifty-two (43%) were treated with azathioprine alone or in combination. Two doses of mRNA vaccines were administered to ninty-eight patients ((81,7%) Moderna: 20, Pfizer: 78). The other type of vaccines were AstraZeneca (16) Sputnik V (3) and Sinopharm (3). The median anti-SARS-CoV-2S antibody level was 2733 U/mL (IQR: 535-7764) on the 14th day after vaccination (IQR: 14-17). Significant differences were revealed between the groups of patients treated with biological agents or non-biological therapy (median: 1649 U/ml vs. 5711.5 U/ml;p=0.013) and between patients recieving mRNA and non-mRNA vaccine (median: 3367.5 U/ml vs. 392.6 U/ml;p<0.001). Considering the varying effect of immunosupression related to combination therapy, biological drugs, azathioprin and other non-immunomodulating treatments antibody response were assesed in these groups also. The median antibody levels were 850,5 U/ml (IQR: 251.0-4899.5), 1837 U/ml (IQR: 544.5-5902), 3141 U/ml (IQR: 1066-7988), 7764 U/ml (IQR: 5601-13808) demonstrating significant differences among them (p<0.001). No correlation between anti-TNF-alpha serum level and antibody response were found. Discussion Altough all vaccines cause seroconversion in IBD patients who are in remission, the rate of seroconversion is lower in patients treated with immunosupressant, biological agent or combo therapy or recieving non-mRNA vaccines. As the level of anti-TNF-alpha agents do not affect the rate of seroconversion there is probably no need for matching the time of vaccination and anti-TNF therapy.

14.
Gastroenterology ; 162(7):S-1008, 2022.
Article in English | EMBASE | ID: covidwho-1967396

ABSTRACT

BACKGROUND: Immune-modulating medications for inflammatory bowel diseases (IBD) have been associated with suboptimal vaccine responses. There is conflicting data with SARS-CoV-2 vaccination. METHODS: We measured SARS-CoV-2 vaccine immunogenicity at 2 weeks post 2nd mRNA vaccine in IBD patients as compared to normal healthy donors (NHD). We measured humoral immune responses to SARS-CoV-2: anti-spike Immunoglobulin G (IgG) and anti-receptor binding domain (RBD) IgG were measured by ELISA, and neutralizing antibody titers were measured using recombinant, reporter SARS-CoV-2. Antigen specific memory B cells were measured using recombinant SARS-CoV-2 proteins. Activation induced marker T cell (AIM) assays were performed using SARS-CoV-2 spike megapools. Immunophenotyping was performed by flow cytometry. RESULTS: We enrolled 29 patients with IBD (19 with Crohn's disease, 10 with ulcerative colitis) on infliximab (IFX) monotherapy (N=9), IFX combination therapy with a thiopurine (N=9), vedolizumab monotherapy (N= 11) as compared to matched NHD (N=12). At 2 weeks post vaccination, all subjects made detectable anti-spike IgG and anti-RBD IgG. There were no differences in anti-spike IgG titers among the different groups. IBD patients on IFX monotherapy, but not IBD patients on IFX combination therapy or vedolizumab monotherapy, had lower anti-RBD and neutralization titers as compared to NHD (p-value: 0.041 and 0.023, respectively) (Fig. 1). There were no significant differences in the percentage of spike-specific or RBD-specific memory B cells in IBD patients as compared to NHD (Fig. 1). There were no differences in the percentage of spike-specific CD4+ or CD8+ T cells in all IBD patients as compared to NHDs (Fig. 2). CONCLUSIONS: We demonstrate overall comparable and perserved cell-mediated immunity to SARS-CoV-2 vaccination in a small cohort of IBD patients treated with a range of different immune-modulating medications as compared to healthy controls. Larger numbers of patients are needed to validate these findings.

15.
Gastroenterology ; 162(7):S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967395

ABSTRACT

Background: Patients with inflammatory bowel diseases (IBD) are commonly treated with immunosuppressive agents. Following the novel corona virus (SARS-CoV-2) pandemic, these patients received early the currently EMA approved vaccines. Data on efficacy and safety of SARS-CoV-2 vaccination on this population are lacking. Methods: Greek IBD patients, from 10 tertiary referral centres, who had completed the initial vaccination protocol with the available anti-COVID-19 vaccines (BNT162b2, mRNA-1273, Ad26.CoV2.S, ChAdOx1) at least two weeks before enrolment, were prospectively studied. Demographic and safety data were collected and blood samples were drawn for serum Anti-S1 IgG measurement [Euroimmun Anti-SARS-CoV-2 QuantiVac ELISA (IgG)]. Results: In total 403 IBD patients (59% Crohn's disease, median age 45 years, 53% male) and 124 healthy controls (HC) were included (Table 1). Antibody testing was conducted after a median of 31 (IQR, 23-46) days post-vaccination. Following a full vaccination regimen, 98% of IBD patients seroconverted (anti-S1 IgG³11 RU/ml). In total, IBD patients had lower anti-S1 levels than HC (RU/ ml 108 vs 133 RU/ml, P=0.00009) Administration of mRNA vaccines resulted in higher seroconversion rates and higher antibody titers than viral vector ones (98.6% vs 93.6%, P= 0.02 and 111.2 RU/ml vs 76 RU/ml, P<0.0001, respectively). Treatment with vedolizumab monotherapy was associated with higher antibody levels than anti-TNFα or ustekinumab monotherapy (P=0.02 and P=0.03). Longer timing between vaccination and antibody measurement was independently associated with impaired vaccine response. In multivariable analysis, specifically in mRNA-vaccinated cohort, older age, anti-TNFα treatment and treatment with biologics plus IMMs were significantly associated with lower antibody response (P=0.01, P=0.008, and P=0.02 respectively). Patients with prior COVID-19 infection showed numerically higher levels of antibodies. All vaccines were safe in IBD patients. Conclusions: Patients with IBD have high seroconversion rates to anti-SARS-CoV-2 vaccines. However, they demonstrate impaired antibody responses compared to HC. Patients receiving viral vector vaccines, and those on anti-TNFα or combination treatment may have further response impairment and it is important to consider booster vaccination in those low-response groups. (Table Presented)

16.
Gastroenterology ; 162(7):S-1006-S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967394

ABSTRACT

Introduction Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions for and unfavorable effects of COVID-19 vaccination in this group. The aim of this study was to investigate the real world use and adverse events (AE) of vaccines against COVID-19 in IBD patients. Aims and Methods Fully vaccinated IBD patients followed in Greek centers were invited to participate in an anonymous online self reporting survey that included information regarding their demographics, clinical characteristics, treatment, vaccination perceptions and potential AE. Patients were vaccinated with either messenger-RNA or viral vector vaccines that are currently EMA approved. AE were stated as any kind of new symptom or sign onset, including localized (at the injection site) or systematic ones (fatigue, headache, allergic reactions, fever, lymphadenopathy, myalgias/arthralgias and gastrointestinal disorders). Results A total of 1007 IBD patients [male 50.5%, median age (IQR) 44 (35-55) years, Crohn's disease 64.3%, history of COVID-19 infection 2.6%] who completed the survey after they have fulfilled their vaccination program were included. Detailed demographics and clinical characteristics of the study population are presented in Table 1. More than half of the patients (51%) stated that they show confidence in vaccination whereas the rest although hesitant admitted the protection it offers. The median (IQR) time between 2nd vaccine dose and questionnaire completion was 15 (5-43) days. There were no serious AE leading to emergency room visit or hospitalization. Total AE were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), reduced to 44% and 51% when excluding isolated injection site reactions respectively. Systemic AEs were more common after D2 (P<0.0001). Very few patients reported new onset abdominal symptoms [abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)]. In the multiple regression analysis AE occurrence was positively associated with young age, female gender and blood type AB rhesus positiveafter both doses, whereas inactive disease was negatively associated with AE only in D1 (p= 0.044) No association with the use of medications including advanced therapy was found (p>0.05), except from corticosteroids after D2 (p=0.003) but it was a small (32/1007 patients) heterogenous (monotherapy, double or triple immunosupression) sample to draw conclusions (Table 2). Conclusions The presence of SARs-CoV-2 vaccination AE in Greek patients with IBD is similar to the reported in other populations. Young age and female gender but not IBD related medications are associated with the development of AEs after both doses. (Table Presented) (Table Presented)

17.
Gastroenterology ; 162(7):S-1006, 2022.
Article in English | EMBASE | ID: covidwho-1967392

ABSTRACT

BACKGROUND Little is known about the impact of immunosuppressants on COVID-19 vaccination in patients with immune-mediated inflammatory diseases (IMID). Although humoral response may be attenuated in patients using immunomodulators (IMM) and TNFinhibitors (anti-TNF), data regarding cellular response are scarce and conflicting. This study was aimed to identify immune response to COVID-19 vaccination in IMID patients. METHODS A prospective observational multicentre cohort study was conducted to examine the immunogenicity of mRNA vaccines to SARS-CoV-2 in adult IMID patients using immunosuppressive therapy (anti-TNF, IMM, anti-TNF+IMM, anti-IL12/23, anti-IL-17, anti-IL-23) or no therapy as compared to healthy controls (HC). Patient details and vaccination history were recorded. Blood samples were drawn at 3 time points: before, 3-4 weeks after first and 2 weeks after second vaccination. Humoral immune response to S and RBD proteins were assessed by ELISA. Neutralization was tested against 4 variants of SARS-CoV-2 by surrogate neutralization ELISA. Cellular immune responses were determined based on analysis of 9 secreted cytokines and cytotoxic molecules after stimulation of PBMC with S peptide pools. Response to N protein was used to assess SARS-CoV-2 exposure. RESULTS A total of 159 subjects (133 IMID patients and 26 HC) were included in this study (median age 42 years [IQR 30-53], 52% male). Of 133 IMID patients, 87 had inflammatory bowel disease, 23 psoriatic arthritis, 18 psoriasis, 11 ankylosing spondylarthritis and 4 rheumatoid arthritis. Of these, 44 used anti-TNF, 9 IMM, 18 anti-TNF+IMM, 33 anti-IL-12/23, 9 anti-IL-17, 10 anti-IL-23 therapy and 10 no therapy. All subjects received 2 doses of mRNA vaccines (2x Pfizer, 2x Moderna or mixed) between December 2020 and September 2021. The vast majority of subjects had minimal binding antibody and T cell responses to N, indicating they were COVID-19 naïve. After dose 1, anti-TNF group had lower IL-2 vs untreated IMID (p<0.01), and the anti-IL-23 group had lower IFN-g vs HC (p<0.01), though there was wide variation in responses within groups. Following dose 2, median responses between groups were mostly similar, but antibody responses were significantly lower in patients on anti-TNF as compared to HC in subjects that received two doses of Pfizer (p=0.01). Pooled data for all subjects combined show a higher response to Moderna over Pfizer in ELISA, neutralization and T cell readouts, and a lower response for those over 60 years of age after dose 2. Longer follow-up is in process to monitor the durability of these responses over time and after third dose. CONCLUSION Immune responses after 2 doses of mRNA vaccines in immunocompromised IMID patients largely reach the level of that of HC albeit antibody responses in the anti-TNF group are weaker and with wide variability between subjects within some groups

18.
Gastroenterology ; 162(7):S-1005-S-1006, 2022.
Article in English | EMBASE | ID: covidwho-1967391

ABSTRACT

INTRODUCTION Patients with inflammatory bowel disease (IBD) may be more susceptible to certain infections including COVID-19. There are concerns regarding the safety and efficacy of the current available COVID-19 vaccines among IBD patients. The aim of this study is to perform a systematic review regarding the willingness of IBD patients to receive these types of vaccines, assess the reported adverse events and the efficacy of the vaccine among IBD patients. METHODS Medline, Embase, Scopus, Web of Science, and Cochrane databases were reviewed since inception till November 11th, 2021, by two independent reviewers. Relevant conference s were manually reviewed to identify additional studies. Studies that reported the willingness or rate of COVID vaccination, the adverse events, and/or efficacy of the COVID vaccine among IBD patients were included. Efficacy was defined as the ability of a vaccine to produce detectable antibodies. Meta-analysis was performed using a bivariate random-effects model. RESULTS 2049 studies were identified through database search and additional 10 conference s were extracted. 24 studies, with the majority (79%) from North America or Europe were included. Four studies reported the rate of adverse events of vaccines ranging from 39% to 74% after the first and second doses of vaccine, respectively. Pooled estimates of nine studies showed that only 59% of IBD patients (95% confidence interval (CI):39%-79%) were willing or had already received a vaccine. Pooled estimates of six studies showed the vaccine was 96% (95% CI: 92%-99%) effective in creating seroconversion in IBD patients. Three studies reported the incidence of break-through infection following COVID vaccination;The pooled estimates showed no statistically significant difference between the risk ratio of IBD patients versus healthy control (Risk difference:0.02 (95%CI: -0.02, 0.06), P-value:0.3). Mean values of antibody level were statistically significantly lower in IBD patients receiving immunosuppression compared with those who were not on immunosuppression (Standardized mean difference: -0.38 (95% CI: -0.58, -0.18), P-value:0.002). CONCLUSION COVID vaccines are protective against preventing COVID-19 infection in IBD patients. However, patients on immunosuppression may have reduced response and could benefit from a booster dose. More importantly, there should be more efforts in encouraging IBD patients towards vaccination. Additionally, is scarce data and further studies are required to assess the global effect of the COVID vaccine in IBD patients, particularly in underdeveloped countries. (Figure Presented)

19.
Gastroenterology ; 162(7):S-676, 2022.
Article in English | EMBASE | ID: covidwho-1967361

ABSTRACT

Background: COVID-19 associated gut microbiome dysbiosis has been strongly linked to more severe disease and has most recently been shown to persist long after symptomatic recovery. While studies have correlated the depletion of gut commensals, like Faecalibacterium and Bifidobacterium, to disease severity, little is known about specific microbes that may be protective against disease, especially in the context of vaccination against SARS-CoV-2. We aimed to characterize changes in the gut microbiota following COVID-19 vaccination and associate them with antibody titers against SARS-CoV-2. Methods: We obtained paired stool samples from a cohort of 8 patients, the first sample taken within 10 days before the beginning of their COVID-19 mRNA vaccine series and the second taken within 10 days after their second vaccine. 16s rRNA gene sequencing and principal coordinate analysis were performed. In parallel, blood samples were also collected at 1, 3, 6, and 12 months to enumerate serum IgG antibody titers. Patients were stratified into 2 groups—medium and high—based on IgG titers following vaccination, wherein the `high' response group maintained significantly higher titers beyond 6 months follow-up. We used linear discriminant analysis effect size (LefSe) to estimate which microbes significantly differed at baseline between the 2 response groups. Results: The gut microbiome composition differed before and after vaccination for all patients, with medium responders showing significant differences by both Bray-Curtis dissimilarity (p = 0.04, pairwise PERMANOVA) and unweighted UniFrac (p = 0.03, pairwise PERMANOVA) beta diversity metrics (Figure 1), while differences within high responders were non-significant. The most abundant families present before vaccination in all subjects included Lachnospiraceae, Bacteroidaceae, Ruminococcaceae, and Enterobacteriaceae. Following vaccination, a stark contraction in the relative abundance of the family Bacteroidaceae occurred in all subjects, and in the majority of cases was accompanied by a concomitant increase in the abundance of Lachnospiraceae. The relative abundances of Ruminococcaceae, Bifidobacteriaceae, and Streptococcaceae were also increased in the majority of post-vaccination samples. Post-vaccination samples were also increased in community evenness and community richness for both response groups. LefSe analysis indicated that the orders Bifidobacteriales and Lactobacillales were significantly associated with high responders (Figure 2). Conclusion: Altogether, these findings demonstrate an association between the gut microbiota and COVID-19 immunity and highlight a potential link between specific taxa and the strength of humoral responses following vaccination. (Figure Presented) (Figure Presented)

20.
Gastroenterology ; 162(7):S-601, 2022.
Article in English | EMBASE | ID: covidwho-1967350

ABSTRACT

Introduction: The International Organization for the Study of Inflammatory Bowel Disease (IBD) has recommended vaccination of all patients with IBD as soon as they are able to receive the vaccine, regardless of immune-modifying therapies or disease activity. Nevertheless, some articles have shown a large percentage of individuals who are unwilling to receive the COVID-19 vaccine with fear of potential adverse events. Moreover, IBD patients were excluded from safety and efficacy phase III vaccine trials, as well as those treated with immunosuppressive therapies. Thus, we performed a monocentric real-life survey to assess the adverse events of COVID-19 vaccination among patients with IBD under biologic therapy. Methods: All adult individuals with IBD undergoing biological treatment and followed at Centro Hospitalar Universitário de São João were included. Each patient answered a telephone questionnaire conducted by a gastroenterologist. Results: A total of 301 patients agreed to participate in the study, the majority females (53.2%), with a median age of 42 years old (IQR 32-54). IBD diagnosis included Crohn's disease (76.7%) and ulcerative colitis (23.3%). The proportions of patients receiving tumor necrosis factor inhibitors, ustekinumab and vedolizumab were 75.4%, 13.0% and 11.6%, respectively. This cohort included 239 vaccinated patients (59.0% Pfizer-BioNTech, 20.5% Moderna, 14.2% Janssen and 6.3% AstraZeneca), 173 (57.5%) of whom had complete vaccination. Of the remaining individuals, only 12 did not intend to be vaccinated. The main reasons were: fear of potential adverse events (50.0%), lack of confidence in the vaccine development process (25.0%) and little information about vaccination in IBD patients (16.6%). Among vaccinated patients, the overall adverse events frequency was 56.8% after dose 1 (D1) and 74.1% after dose 2 (D2). The most common symptoms were localized injection-site reactions and fatigue. The vast majority of adverse events were mild and lasted only a few days. Only 4 (1.7%) patients had IBD exacerbation after the vaccine. No serious adverse events were reported and any patient was hospitalized. The percentage of adverse events was higher among patients younger than 50 years (77.6% vs 62.5% after D1, p=0.011;83.0% vs 58.8% after D2, p=0.002). No significant differences were seen based on sex, vaccine type, biologic drug or disease type. Compared to the general population, a lower percentage of IBD patients suffered from local or systemic reactions during the first week after vaccination (Figure 1). Conclusion: We found a high acceptance rate and a good safety profile of SARS-CoV-2 vaccination in IBD patients treated with biologics drugs. Indeed, adverse events were common but overall mild and transitory. These data support the prioritization and rapid vaccination of these individuals. (Figure Presented) Figure 1 – Adverse reactions occurring within seven days after vaccination in IBD patients compared with the general population.

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