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1.
Current Topics in Pharmacology ; 26:39-47, 2022.
Article in English | EMBASE | ID: covidwho-20243739

ABSTRACT

This study compares the serological antibody level post-COVID-19 vaccine among healthy subjects and psychiatric patients on antidepressant therapy. It also examines the difference in antidepressants' side effects experienced by psychiatric patients following the completion of two vaccine doses. A comparative posttest quasi-experimental study was conducted among healthy subjects and psychiatric patients on antidepressant medication in a teaching hospital in Malaysia. Elecsys Anti-SARS-CoV-2 assay was used to detect the antibody titre between weeks 4 and 12 post vaccination. The antidepressant side-effect checklist (ASEC) was used to monitor the occurrence of antidepressant-related side effects pre-and post-vaccination. 24 psychiatric patients and 26 healthy subjects were included. There was no significant difference in the antibody level between the patients (median = 1509 u/ml) and the healthy subjects (median = 995 u/ml). There was no significant worsening in the antidepressant-related side effects. The antibody level post-COVID-19 vaccine did not differ significantly between patients on antidepressant therapy and healthy subjects. Additionally, there was no change in the antidepressant side effects experienced by the patients following the completion of the vaccine.Copyright © 2022, Research Trends (P) LTD.. All rights reserved.

2.
Pediatria Polska ; 98(1):79-82, 2023.
Article in English | EMBASE | ID: covidwho-20241151

ABSTRACT

The most common causes of acute hepatitis in children are hepatitis A and autoimmune hepatitis. Hepatitis in the course of Wilson's disease is sporadically registered in adolescents. An increase of activity of aminotransferases both in the course of multisystem inflammatory syndrome in children (MIS-C) and in the course of COVID-19 has been observed. Hepatitis is common in children with MIS-C and is associated with a more severe presentation and persistent elevation of liver function tests. To date, no cases of acute hepatitis in children due to COVID-19 have been reported. We present 2 cases of acute hepatitis in children where the only cause seems to be a previous asymptomatic SARS-CoV-2 infection.Copyright © 2023 Termedia Publishing House Ltd.. All rights reserved.

3.
Cancer Research Conference: American Association for Cancer Research Annual Meeting, ACCR ; 83(7 Supplement), 2023.
Article in English | EMBASE | ID: covidwho-20238091

ABSTRACT

Introduction Patients with hematological malignancies, including multiple myeloma (MM), experience suboptimal responses to SARS-CoV-2 vaccination. Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) are precursors to MM and exhibit altered immune cell composition and function. The SARS-CoV-2 pandemic and the subsequent population-wide vaccination represent an opportunity to study the real-life immune response to a common antigen. Here, we present updated results from the IMPACT study, a study we launched in November 2020 to characterize the effect of plasma cell premalignancy on response to SARS-CoV2 vaccination (vx). Methods We performed: (i) ELISA for SARS-CoV-2-specific antibodies on 1,887 peripheral blood (PB) samples (237 healthy donors (HD), and 550 MGUS, 947 SMM, and 153 MM patients) drawn preand post-vx;(ii) single-cell RNA, T cell receptor (TCR), and B cell receptor (BCR) sequencing (10x Genomics) on 224 PB samples (26 HD, and 20 MGUS, 48 SMM, and 24 MM patients) drawn preand post-vx;(iii) plasma cytokine profiling (Olink) on 106 PB samples (32 HD, and 38 MGUS and 36 SMM patients) drawn pre- and post-vx;and (iv) bulk TCR sequencing (Adaptive Biotechnologies) on 8 PB samples from 4 patients (2 MGUS, 2 SMM) drawn pre- and post-vx. Results Patients with MGUS and SMM achieved comparable antibody titers to HD two months post-vx. However, patient titers waned significantly faster, and 4 months post-vx we observed significantly lower titers in both MGUS (Wilcoxon rank-sum, p=0.030) and SMM (p=0.010). These results indicate impaired humoral immune response in patients with MGUS and SMM.At baseline, the TCR repertoire was significantly less diverse in patients with SMM compared to HD (Wilcoxon rank-sum, p=0.039), while no significant difference was observed in the BCR repertoire (p=0.095). Interestingly, a significant increase in TCR repertoire diversity was observed post-vx in patients with SMM (paired t-test, p=0.014), indicating rare T cell clone recruitment in response to vaccination. In both HD and patients, recruited clones showed upregulation of genes associated with CD4+ naive and memory T cells, suggesting preservation of the T cell response in SMM, which was confirmed by bulk TCR-sequencing in 4 patients.Lastly, by cytokine profiling, we observed a defect in IL-1beta and IL-18 induction post-vx in patients with SMM compared to HD (Wilcoxon rank-sum, p=0.047 and p=0.015, respectively), two key monocyte-derived mediators of acute inflammation, suggesting an altered innate immune response as well. Conclusion Taken together, our findings highlight that despite the absence of clinical manifestations, plasma cell premalignancy is associated with defects in both innate and adaptive immune responses. Therefore, patients with plasma cell premalignancy may require adjusted vaccination strategies for optimal immunization.

4.
Value in Health ; 26(6 Supplement):S119-S120, 2023.
Article in English | EMBASE | ID: covidwho-20238059

ABSTRACT

Objectives: The United Kingdom (UK) implemented an autumn 2022 booster programme that allowed those at higher risk from COVID-19, including those >= 50 years, to receive a booster to increase protection against infection and subsequent severe outcomes. As the UK transitions out of the pandemic, future booster campaigns may be required to maintain protection against such outcomes. The objective of this analysis was to estimate the value-based price (VBP) for a bivalent COVID-19 vaccine used in a future autumn 2023 campaign in the UK to protect people aged >= 50 years. Method(s): A Susceptible-Exposed-Infected-Recovered (SEIR) model was used to predict infections across a 1-year time horizon starting September 2023 with and without an autumn booster campaign. Initial effectiveness was predicted to be 89% and 97% against infection and hospitalization respectively based on BA.4/BA.5 antibody titers and correlates of protection. A monthly decline in protection of 1.4% and 4.8%, respectively, was assumed based on monovalent vaccine data. A decision tree was used to predict the quality-adjusted life-years (QALY) lost and costs associated with infections. Result(s): Considering a willingness-to-pay (WTP) threshold of 20,000/QALY, the VBP associated with an autumn 2023 booster campaign is 343/dose. Considering a WTP threshold of 30,000, the VBP increases to 476. In sensitivity analyses, excluding the post-infection costs (e.g., long COVID), reduces the VBP by 11%. Varying the hospitalization rates by +/-25% changes the VBP by +/- 6%. Varying hospitalization unit costs only impacts the VBP by 1%. Doubling the rate of waning for booster effectiveness increases the VBP by 54% because the effectiveness provided from past campaigns falls faster and an autumn 2023 booster becomes more valuable. Conclusion(s): While the trajectory of COVID-19 incidence is highly uncertain, pricing the bivalent booster lower than the VBP is expected to result in a cost-effective strategy for the UK.Copyright © 2023

5.
Clinical Immunology ; Conference: 2023 Clinical Immunology Society Annual Meeting: Immune Deficiency and Dysregulation North American Conference. St. Louis United States. 250(Supplement) (no pagination), 2023.
Article in English | EMBASE | ID: covidwho-20237070

ABSTRACT

We conducted a retrospective study in the adult primary immunodeficiency clinic at UAB examining COVID-19 infection and COVID-19 antibody response from vaccination, natural infection, and immunoglobulin replacement from February 2021 to November 2022. Our goal was to determine if nucleocapsid and spike antibodies could be found in our PID patients and if these antibodies could be derived from natural infection, vaccination, or antibody replacement exclusively or combinatory. We hypothesized that increasing antibodies would be detected in our population as the COVID period extended. Two hundred and forty-five subjects were tracked over 336 clinic visits during this period. Our PID population included subjects with CVID, XLA, thymoma, hypogammaglobulinemia, IgA deficiency, IgG subclass deficiency, specific antibody deficiency, Down syndrome, IgM deficiency, and patients with recurrent sinopulmonary infections. We had 196 females and 45 males in our study. In our patient population, 47% of our patient had known COVID-19 infection. Of those 47%, 21% of those infected patients had COVID-19 at least twice. Of those infected, three did not have COVID-19 spike antibodies and chose not to get vaccinated either. Two of those patients were not on IVIG and one was on Pangyza. Of those infected, 70% (n = 80) were on IgG infusions compared to those uninfected, 77% (n = 96) were on IgG infusions. Of interest, we had three XLA patients and all three had COVID-19 infection in the summer 2021. Two of them tested positive for nucleocapsid and spike antibodies in high titers and they were receiving Gammagard or Gamunex infusions, suggesting that these immunoglobulin preparations contain COVID-19 antibodies. We are still in the process of analyzing our data to see if diagnosis, IgG preparations, date of testing, B cell numbers, and drugs play a role in producing nucleocapsid antibodies and high spike antibody titers.Copyright © 2023 Elsevier Inc.

6.
Clinical Immunology ; Conference: 2023 Clinical Immunology Society Annual Meeting: Immune Deficiency and Dysregulation North American Conference. St. Louis United States. 250(Supplement) (no pagination), 2023.
Article in English | EMBASE | ID: covidwho-20235009

ABSTRACT

Background: Intravenous (IV) and subcutaneous (SC) Immunoglobulin G (IG) replacement products are in wide use in patients with primary antibody deficiency syndrome (PAD). There is limited data on the levels of anti-SARS-CoV-2 spike antibodies in IG products or their ability to neutralize emerging SARS-CoV-2 variants. There is lack of data on the impact of IG therapy on serum anti-SARS-CoV-2 spike or neutralizing antibody titers in PAD patients. Method(s): We measured anti-SARS-CoV-2 anti-spike antibody levels and neutralizing titers against historical (WA1/2020) and variant (B.1.617.2 [Delta] and BA.1 [Omicron]) strains in 158 lots of 6 different IG products, collected between August 2021 to April 2022 and manufactured between December 2019 to December 2021. IG products were compared to serum from 20 healthy donors vaccinated with 2 doses of Pfizer-BioNTech mRNA vaccine. Serum anti-spike antibody level and SARS-CoV-2 neutralization activity were measured in 27 PAD patients treated with the tested IG products. Result(s): Anti-spike antibody titers started to increase in products manufactured in March 2021 and reached peak level, comparable to vaccinated healthy donors, in products manufactured in August 2021 (Fig. 1). The neutralization activity against WA1/2020 and Delta strains showed a similar pattern (Fig. 2). However, 95% of the tested products had no neutralization activity against Omicron. Until November 2021, IVIG products infused to patients in the study had anti-spike titers comparable to unvaccinated healthy donors (Fig. 3). Beginning in February 2022, IVIG products had anti-spike titers comparable to vaccinated healthy controls. Concurrent with a rise in anti-spike antibodies in IG products, PAD patients showed an increase in serum levels of anti-spike antibody and neutralizing activity against WA1/202 and Delta but not against Omicron variants. Testing of immunoglobulin replacement products neutralization activity against emerging variants BQ.1 and BQ.1.1 is underway.[Formula presented][Formula presented][Formula presented] Conclusion(s): The anti-SARS spike antibody and neutralization activity of IVIG products lags after the emergence of COVID-19 variants and currently have poor activity against Omicron strain. Because of the protracted manufacturing process, this is expected to be an ongoing challenge. As variants emerge, clinicians should consider additional means of protection for PAD patients such as vaccination, or prophylaxis with monoclonal antibodies.Copyright © 2023 Elsevier Inc.

7.
Vaccines (Basel) ; 11(5)2023 Apr 23.
Article in English | MEDLINE | ID: covidwho-20237346

ABSTRACT

This study aimed to assess long COVID, and describe immunogenicity against Omicron variants following BNT162b2 vaccination. A prospective cohort study was conducted among children (aged 5-11) and adolescents (aged 12-17) who had SARS-CoV-2 infection from July to December 2021 (Delta predominant period). Long COVID symptoms were assessed by questionnaires at 3 months after infection. Immunogenicity was evaluated by using a surrogate virus-neutralizing antibody test (sVNT) against the Omicron variant. We enrolled 97 children and 57 adolescents. At 3 months, 30 children (31%) and 34 adolescents (60%) reported at least one long COVID symptom, with respiratory symptoms prevailing (25% children and 32% adolescents). The median time from infection to vaccination was 3 months in adolescents and 7 months in children. At 1 month following vaccination, in children who received one-dose and two-dose BNT162b2 vaccines, the median (IQR) sVNT against Omicron was 86.2% inhibition (71.1-91.8) and 79.2% inhibition (61.5-88.9), respectively (p = 0.26). Among adolescents who received one-dose and two-dose BNT162b2 vaccines, the median (IQR) sVNT against Omicron was 64.4% inhibition (46.8-88.8) and 68.8% inhibition (65.0-91.2) (p = 0.64). Adolescents had a higher prevalence of long COVID than children. Immunogenicity against the Omicron variant after vaccination was high and did not vary between one or two doses of the vaccine in either children or adolescents.

8.
Asian Journal of Pharmaceutical Research and Health Care ; 15(1):83-90, 2023.
Article in English | Web of Science | ID: covidwho-2328023

ABSTRACT

Background: Vaccine is an essential tool to limit the health of the COVID-19 pandemic. AstraZeneca vaccine already provided promising effectiveness data. Still, the study must check the correlation between vaccination and antibody titer. Aim: This study aims to evaluate antibody titer after AstraZeneca vaccination based on the age group. Materials and Methods: This study used a prospective cross-sectional method with convenience sampling. Inclusion criteria were all Indonesian citizens above 18 years old who were vaccinated at UTA'45 Jakarta Vaccine Center with no history of COVID-19 before the vaccination and had filled up the informed consent. Results: This study's total sample was 102 females;51.90%, residents of Java Island;91.17% had comorbidities;50,98%, smokers;9,80%, alcohol drinker;9,80%, exercise;80,39%, blood pressure;128/73, SpO2: 97,82. Most participants aged around 30 years had a body mass index of 23.33. Age, comorbidity, smoking, alcohol, and exercise habit significantly correlate with the increase of the participants' antibodies (P < 0.001). The age shows that the younger the participant, the higher the titer antibody 2 will be (P = 0.001, 95% confidence interval [CI],-1.935,-0.694). The exercise shows that the participant with the routine practice will have a higher titer antibody 2 (P = 0.002, 95% CI, 12.016, 51.791). Antibody titer for participants younger than 35 years old increased 5.7 times while for participants between 35 and 45 years old was 3.9 times. Another group (>45-55 years old) has shown an improvement in antibody titer at 1.7 times, but the last group (>55 years old) described an increase in antibody titer at 232.3 times. Conclusions: Age, comorbidity, smoking, alcohol, and exercise contributed to the increase in titer antibody 2 value of the AstraZeneca vaccine participants. Participants in the age group <35 years have an excellent immune system.

9.
Hepatology International ; 17(Supplement 1):S259, 2023.
Article in English | EMBASE | ID: covidwho-2324271

ABSTRACT

Background: More than a year has passed since the first coronavirus vaccines were widely used. However, some healthcare workers are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) despite full vaccination. The immune effect of SARSCoV- 2 vaccines attenuates in a few months in contrast to other universal vaccines, such as the hepatitis B vaccine, which have an immune effect that lasts for a longer time. In addition, the neutralizing antibody (Ab) titers can be measured only in limited medical institutions. In this study, we aimed to investigate the factors that predict SARS-CoV-2 infection in healthcare workers after vaccination. Method(s): In this study, we enrolled one thousand one hundred and thirty-three healthcare workers (826 women, 307 men) after second inoculation of the BNT162b2 vaccine (Pfizer /BioNTech) in February- April 2021. Medical checkups and self-reported questionnaires were used to collect medical histories and demographic characteristics. The Alinity SARS-CoV-2 IgG II Quant (Abbott) quantitative IgG spike protein serology assay was examined in a cohort of participants 1, 4, 6 months after the second vaccination, and 1 month after the third vaccination of the BNT162b vaccine. Lower Ab titers were defined under median at each time point. The relationships between SARS-CoV-2 infection and these factors were analyzed. Result(s): The mean observation period was four hundred and fortyeight days. The median titers at 1, 4, 6 months after the second vaccination were 9293 U/mL (interquartile range [IQR], 5840-14392 U/mL), 1658 U/mL (IQR, 999-2676) and 832 U/mL (IQR, 523-1300), respectively. The risk factors for lower Ab titers were age (60 years older, odds ratio [OR], 2.08), presence of current illness (OR 1.52), smoking habit (OR 2.36), and no fever after the second vaccination (OR 2.44). The median titers at 1 month after the third vaccination was 13780 U/mL (IQR, 9085-22722), and the risk factor for lower Ab titers was hepatitis B surface Ab (HBsAb) negative (OR 1.38). The total 1-year cumulative infection rate was 4.9%. The median infection period was three hundred and twenty days (IQR, 298-365) after the second vaccination. The risk factors of infection were age (30 s and 40 s), and HBsAb negative. The 1-year cumulative infection rate of 30-40 s and other ages were 6.6% and 3.7%, respectively (p<0.01). The 1-year cumulative infection rate of HBsAb negative participants with 30-40 s and other age were 7.7% and 4.9%, respectively (p = 0.064), while that of HBsAb positive participants with 30-40 s and other age were 6.7% and 1.7%, respectively (p<0.01). Conclusion(s): HBsAb and age can become prognostic factors to be infected with SARS-CoV-2 after vaccination. Especially, HBsAb negative people under 50 years old should pay attention to SARSCoV- 2 infection even after second vaccination.

10.
Extreme Medicine ; - (2):5-12, 2021.
Article in English | EMBASE | ID: covidwho-2324010

ABSTRACT

The level and duration of protective immunity are often analyzed qualitatively or semi-quantitatively. The same strategy is applied to the analysis of antibody dynamics. At some point in time t after exposure or immunization, the presence of immunity against the infection is inferred from the level of specific antibodies by comparing it to a reference value. This approach does not account for the stochastic nature of human disease after exposure to a pathogen. At the same time, it is not fully clear what antibody level should be considered protective. The aim of this study was to develop a mathematical model for quantitative determination of protective immunity against SARS-CoV-2 and its duration. We demonstrate that the problem of describing protective immunity in quantitative terms can be broken down into 2 interrelated problems: describing the quantitative characteristics of a pathogen's virulence (in our case, the pathogen is SARS-CoV-2) and describing the dynamics of antibody titers in a biological organism. Below, we provide solutions for these problems and identify parameters of the model which describes such dynamics. Using the proposed model, we offer a theoretical solution to the problem of protective immunity and its duration. We also note that in order to quantitatively determine the studied parameters in a homogenous population group, it is necessary to know 5 parameters of the bivariate probability density function for correlated continuous random variables: the infective dose of the pathogen and the antibody titer at which the disease develops and which are still unknown.Copyright © Extreme Medicine.All right reserved.

11.
International Journal of Infectious Diseases ; 130(Supplement 2):S84, 2023.
Article in English | EMBASE | ID: covidwho-2323966

ABSTRACT

Intro: During the pandemic of COVD-19, several vaccines have been developed and are currently used worldwide. However, head-to-head studies comparing various vaccines are limited. Therefore, This single-center, prospective, realworld study. head-to-head study of compared the effectiveness of BNT162b2 (Pfizer BioNTech), mRNA-1273 (Moderna) ChAdOx1-S (Astra Zeneca) vaccines. The kinetics of SARS-CoV2 spike antibodies were monitored post-vaccination and following two booster doses in COVID-19 naive and previously infected adults. Method(s): The primary outcome was the emergence of virologically positive COVID-19 cases after vaccine completion. The secondary outcome was the occurrence of postvaccination COVID-19-related hospitalizations. The titers of anti-SARS-CoV-2 IgG antibodies against the S1 subunit of the virus's spike protein were measured after the first and second doses of the three vaccines and the booster doses. Finding(s): The current study enrolled and followed 1550 participants who received ChAdOx1-S or BNT162b2, or mRNA-1273, and 1550 non-vaccinated subjects between March 2021 and February 2022. After completing two vaccine doses, the effectiveness in preventing COVID-19 cases was 89.2%, 95.5%, and 94.6% for ChAdOx1-S or BNT162b2, or mRNA-1273, respectively. Four COVID-19-related hospitalizations (0.26%) were reported in the vaccinated versus 648 (41.81%) non-vaccinated participants (P<0.0001). Following the Pfizer booster dose, no COVID-19-positive cases or hospitalizations were reported. In the three vaccines, SARS-CoV2 antibody titers increased gradually after the first dose, peaked 3-4 weeks after the second dose, then declined after 28-32 weeks. Enhanced antibody response was observed after the booster dose and was maintained until the end of follow-up. Comorbidities were associated with lower antibody titers, particularly diabetes, autoimmune diseases, and advanced renal diseases. Conclusion(s): The study showed that the three COVID-10 vaccines effectively reduced the risk of virologically confirmed COVID-19 disease and prevented severe illness and hospitalizations in COVID-19 naiive and previously infected. Booster doses enhance the SARS-CoV2 antibody response and decrease the incidence of virologically proven severe COVID-19.Copyright © 2023

12.
Hepatology International ; 17(Supplement 1):S162, 2023.
Article in English | EMBASE | ID: covidwho-2323827

ABSTRACT

Background/Aims: The global pandemic of COVID-19 has caused tremendous loss of human life since 2019. Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is one of the best policies to control the pandemic. The vaccination efficacy in Taiwanese patients with different comorbidities is elusive and to be explored. Method(s): Uninfected subjects who received 3-doses of mRNA vaccines (Moderna, BioNTech), non-replicating viral vector-based vaccines (AstraZeneca, AZ) or protein subunit vaccines (Medigen COVID-19 vaccine, MVC) were prospectively enrolled. SARSCoV2- IgG spike antibody level was determined (Abbott [SARS-CoV- 2 IgG II]) within 3 months after the last dose of vaccination. Charlson Comorbidity Index (CCI) was applied to disclose the association of vaccine titer and underlying comorbidities. Result(s): A total of 824 subjects were enrolled in the current study. The mean age was 58.9 years and males accounted for 48.7% of the population. The proportion of CCI with 0-1, 2-3 and>4 was 52.8% (n = 435), 31.3% (n = 258) and 15.9% (n = 131), respectively. The most commonly used vaccination combination was AZ-AZ-Moderna (39.2%), followed by Moderna-Moderna-Moderna (27.8%) and AZAZ- BioNTech (14.7%), respectively. The mean vaccination titer was 3.11 log BAU/mL after a median 48 days of the 3rd dose. Subjects of male gender, lower body mass index, chronic kidney disease, higher CCI, and receiving AZ-AZ based vaccination were likely to have a lower titer of antibody. There was a decreasing trend of antibody titer with the increase of CCT (trend P<0.001). Linear regression analysis revealed that AZ-AZ-based vaccination (beta: 0.341, 95% confidence intervals [CI]: 0.144, 0.21, P<0.001) and higher CCI (beta: - 0.055, CI: - 0.096, - 0.014, P = 0.009) independently correlated with low IgG spike antibody levels. Conclusion(s): Patients with more comorbidities had a poor response to 3 doses of COVID-19 vaccination. Further studies are warranted to clarify the efficacy of booster vaccination in the population. The vaccine titer did not differ between patient with or without chronic liver disease.

13.
Journal of Clinical Rheumatology ; 29(4 Supplement 1):S8-S9, 2023.
Article in English | EMBASE | ID: covidwho-2322015

ABSTRACT

Objectives: Patients with immune-mediated rheumatic diseases (IMRDs) develop more severe outcomes of Coronavirus disease 2019 (COVID-19). Recent studies have contributed to understand the safety and efficacy of COVID-19 vaccines in IMRDs, suggesting that different diseases and therapies may interfere on immunization efficacy. In this study we analyze the immunogenicity of COVID-19 vaccines in patients with Systemic Vasculitides (VASC), the rate of COVID-19 and the frequency of disease relapse following immunization. Method(s): We included patients with VASC (n = 73), a subgroup of the SAFER study (Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease), a longitudinal, multicenter, Brazilian cohort.We analyzed the geometric means of IgG antibody against receptor-biding domain of protein spike of SARS-CoV-2 (anti-RBD) after two shots of CoronaVac (Inactivated vaccine), ChadOx-1 (AstraZeneca) or BNT162b2 (Pfizer-BioNTech). IgG anti-RBD was measured by chemiluminescence test. We assessed new-onset COVID-19 episodes, adverse events (AE) and disease activity for each VASC. Result(s): The sample included Behcet's disease (BD) (n = 41), Takayasu arteritis (TAK) (n = 15), antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) (n = 14), polyarteritis nodosa (n = 7) and other small vessel VASC(n = 6). The majority of patients were female (69%) without comorbidities (49%) and a median age of 37 years. The most common medication was conventional synthetic disease-modifying anti-rheumatic drugs, followed by biologic drugs. No patient received rituximab at baseline. Most patients received CoronaVac (n = 25) or ChadOx-1 (n = 36), while four received BNT162b2. Baseline IgG-RBD means were 1.34 BAU/mL. They increased to 3.89 and 5.29 BAU/mL after the 1st and 2nd vaccine dose, respectively. ChadOx-1 had higher antibody titers than CoronaVac (p = 0.002). There were no differences between different VASC. There were 3 cases of COVID-19 after immunization with CoronaVac. BD patients had a tendency for more cutaneous-articular activity following ChadOx-1. There were no severe relapses and no serious adverse events. Conclusion(s): Our results show the safety of different SARS-CoV-2 vaccines in VASC population. A progressive increase of IgG-RBD antibodies was observed after each dose. ChadOx-1 led to higher IgG-RBDgeometricmeans compared toCoronaVac. Finally, even though ChadOx-1 presented a tendency of triggering mild disease activity, there were no significant disease activity following vaccination in VASC patients. .

14.
International Journal of Infectious Diseases ; 130(Supplement 2):S100, 2023.
Article in English | EMBASE | ID: covidwho-2322005

ABSTRACT

Intro: Different vaccines against COVID-19 have been approved by the World Health Organization (WHO) at different stages, however, limited data is available on long-term kinetics of antibodies induced by vaccines. This study was performed to investigate the persistence and dynamicity of BBV-152 (Covaxin)- and AZD1222 (Covishield)-induced immunoglobulin-G (IgG) antibodies over the year and neutralizing antibodies' status after the one-month post booster dose. Method(s): This 52-week longitudinal cohort study documented antibody persistence and neutralizing antibody status among 278 health-care workers (HCWs) from four different healthcare and research facilities in Odisha, enrolled in January 2021 and continued until March 2022. An automated chemiluminescence immune assay (CLIA) platform from Abbott Diagnostics was used to quantify IgG antibodies against SARS-CoV-2's spike receptor-binding domain (RBD) and a surrogate virus neutralization test (sVNT) was performed by enzyme-linked immunosorbent assay (ELISA). If any participants developed any symptoms of COVID-19, nasopharyngeal swabs were collected and sent to ICMR- RMRC, Bhubaneswar for RT-PCR confirmation. Finding(s): Among the 243 participants, 119 HCWs (48.97%) were Covaxin recipients and the remaining 124 (51.02%) were Covishield recipients. During the seven follow- ups, 104 participants (42.79%) were identified as vaccine breakthrough cases. In 139 non-infected HCWs, the median antibody titer significantly waned after ten months of double dose, both for Covaxin (342.7 AU/mL at DD1 vs 43.9 AU/mL at DD10) and Covishield (2325.8 AU/mL at DD3 vs 595.2 AU/mL at DD10). No statistically significant differences in antibody titers were observed based on age, gender, comorbidities, and blood groups. The median inhibition activity of sVNT was increased significantly for Covaxin and Covishield booster recipients. Among the booster dose recipients, 24 had breakthrough cases by the Omicron variant. Conclusion(s): Results of this longitudinal cohort study can be used to implement vaccination strategies and could also aid in tracking and designing vaccine mandates to minimize vaccine escape.Copyright © 2023

15.
Rheumatology (United Kingdom) ; 62(Supplement 2):ii51, 2023.
Article in English | EMBASE | ID: covidwho-2326056

ABSTRACT

Background/Aims Patients with immune-mediated rheumatic diseases (IMRD) are commonly treated with immunosuppressors and are prone to infections. Recently introduced mRNA SARS-Cov2 vaccines have demonstrated extraordinary efficacy across all ages. Immunosuppressed patients were excluded from phase III trials with SARS-We aim to fully characterize B and T cell immune responses elicited by mRNA SARS-Cov2 vaccines in patients with rheumatic diseases under immunotherapies, and to identify which drugs reduce vaccine's immunogenicity. Methods Humoral, CD4 and CD8 immune responses were investigated in 147 SARS-Cov2-naive patients with selected rheumatic diseases under immunosuppression after a two-dose regimen of SARS-Cov2 mRNA vaccine. Responses were compared with age, gender, and diseasematched IMRD patients not receiving immunosuppressors and with healthy controls Results IMRD patients showed decreased seroconversion rates (63% vs 100%, p=0.04) and cellular immune responses (59% vs 100%, p=0.007). Patients on methotrexate achieved seroconversion in 62% of cases and cellular responses in 80% of cases. Abatacept deeply affected humoral and cellular responses. Rituximab (31% responders) and belimumab (50% responders) showed severely impaired humoral responses but cellular responses were often preserved. Antibody titers were reduced with mycophenolate and azathioprine but preserved with leflunomide. Conclusion IMRD patients exhibit impaired SARS-CoV-2 vaccine-immunogenicity, variably reduced with immunosuppressors. Among commonly used therapies, abatacept and B-cell depleting therapies show the most deleterious effects, while anticytokines preserved immunogenicity. The effects of cumulative methotrexate and glucocorticoid doses on immunogenicity should be considered. Humoral and cellular responses are weakly correlated, but CD4 and CD8 tightly correlate. Seroconversion alone might not reflect the vaccine's immunogenicity.

16.
Journal of Clinical Rheumatology ; 29(4 Supplement 1):S5-S6, 2023.
Article in English | EMBASE | ID: covidwho-2325831

ABSTRACT

Objectives: The use of glucocorticoids (GC) has been associated with increased risk of hospitalization for coronavirus infection and reduced immunogenicity of SARS-CoV-2 vaccines in immune-mediated diseases (IMD) patients. However, there is still controversy of which dose of GC is correlated with impaired vaccine response on each of the diverse COVID-19 vaccines available, as well as the possible influence of other concurrent immunosuppressants. This study aimed at evaluating the effect of GC on serological response after two doses of BNT162b2 (Pfizer/BioNTech), CoronaVac (inactivated SARS-CoV-2 Vaccine) and ChadOx1 (AstraZeneca) and after the booster dose in patients with IMD. Method(s): The data were extracted from a multicenter longitudinal observational Brazilian cohort (SAFER: Safety and Efficacy on COVID19 Vaccine in Rheumatic Disease). Patients >18 years of age with IMD were evaluated after 2 doses of the same vaccine against COVID-19 and after a booster vaccine, applied according to Brazilian National Immunization Program. All patients underwent clinical examination and collected blood samples for immunogenicity tests. Serological response was evaluated by Anti-RBD titers (IgG) at baseline and 4 weeks after each vaccine dose. Result(s): Among the 1009 patients evaluated, 301 were using GC (196/401 SLE, 52/199 RA and 27/74 vasculitis). Patients using GC were younger (38.2 vs 40,8 years, p = 0,002), had higherBMI (27,6 vs 26,4 p = 0,008), higher prevalence of kidney disease (3,3% vs 0,5%, p = 0,001) and of thrombosis (11,6% vs 5,9%, p = 0,002) than non-users. Regarding the type of vaccine, most of the GC users received CoronaVac (61.7%), while only 31.9%of non-users received this vaccine (p alpha 0.001). Although there were similar rates of pre-vaccination infections among them, patients with GC tended to have a higher incidence of confirmed COVID-19 infection after the 2nd dose of the vaccine compared to non-users (4.5% vs 2.0% p = 0.054). The antibody titers after the 1st dose of COVID-19 vaccines were similar between groups, but there was a worse response in the GC group after the 2nd dose (p = 0.039). However, this difference was not statistically significant after the 3rd dose (Figure). Conclusion(s): GC use may compromise vaccine-induced immunogenicity after a 2-dose regimen;however, this effect does not remain significant after the booster dose. Multivariate analysis is still pending to assess the potential difference in the impact of GC on the immune response depending on GC dose, type of vaccine and associated drugs.

17.
American Journal of Gastroenterology ; 117(10 Supplement 2):S2117, 2022.
Article in English | EMBASE | ID: covidwho-2325639

ABSTRACT

Introduction: In the US there has been a recent outbreak of adenovirus hepatitis in the pediatric population. However, to our knowledge, there has been only one reported case of adenovirus hepatitis in an immunocompetent adult. We have identified another such case. Case Description/Methods: A 25 year old female with no medical history presented with abdominal pain, nausea, vomiting, diarrhea, and subjective fevers for two weeks and was found to have transaminitis 25-30x the upper limit of normal, which were: AST 791, ALT 542, ALP 92, and total bilirubin of 2.9. The patient reported no prior history of liver disease. She denied alcohol, tobacco, illicit drugs, or herbal medications, but did report taking acetaminophen 1500 mg daily for two weeks. Serum acetaminophen levels were normal and serum and urine toxicology were negative. US with doppler was unremarkable, CT showed cholelithiasis, MRCP showed a normal common bile duct without obstructive calculus. Autoimmune causes of hepatitis, ceruloplasmin and alpha-1 antitrypsin were all unremarkable. HAV, HBV, HCV, HDV, HEV, CMV, HSV, VZV, EBV, HIV, and COVID19 were all negative. Ultimately, the serology for adenovirus was positive. After a week of supportive treatment, the patient's labs trended down and symptoms resolved. Discussion(s): Adenovirus is confirmed by a rise in antibody titer or by virus detection. Coagulative necrosis in histopathology is a finding in liver biopsies if they are pursued in unexplained cases of liver injury. Ultimately, adenovirus hepatitis can be diagnosed once all common causes of hepatitis have been excluded. In the current outbreak, only children have been getting adenovirus hepatitis. In adults, a high prevalence of neutralizing antibodies contributes to immunity, and therefore only in immunocompromised states, do adults get such an infection. Supportive care with IV fluids, electrolyte correction, and antiemetics usually is enough with eventual symptomatic and laboratory improvement as it was for our patient. Studies have shown that extensive disease can be treated with antiviral drugs, cidofovir, and ribavirin. Our patient's history of acetaminophen use is a confounder, however, her normal serum level and her symptoms suggestive of an infectious cause made acetaminophen less of a culprit. We hypothesize that our patient's use of acetaminophen when she was initially exposed to the virus is what made her susceptible to developing adenovirus hepatitis and we hope this case adds insight for clinicians dealing with future adult cases.

18.
International Journal of Infectious Diseases ; 130(Supplement 2):S132, 2023.
Article in English | EMBASE | ID: covidwho-2325221

ABSTRACT

Intro: Children and Young people were the last group in England be offered COVID-19 vaccination (from September 2021), thus were the largest susceptible group when SARS-CoV-2 Omicron variants emerged. We monitored vaccine and naturally-derived antibodies in schools between November 2021 and March 2022. Method(s): We conducted three large surveys (November 2021, January and March 2022) in a nationally representative random sample of primary and secondary schools, stratified by regions. Oral fluid samples were tested for IgG antibodies against SARS-CoV-2 nucleocapsid (anti-NP) and spike (anti-S1) proteins using novel validated ELISAs;vaccines used in England elicit anti-S1 antibodies only. We calculated weighted prevalences for each survey, and used multilevel logistic regression to investigate associations with socio-demographic factors. Finding(s): Overall 11311 students contributed 22478 biological samples (respectively 4840, 7549 and 10089 in rounds 1, 2 and 3, with similar socio- demographic characteristics). In 4-11 year olds, not eligible for vaccination, anti- S1 and anti-NP antibody prevalences were 31.3% and 26.6%, 46.2% and 43.8%, and 53.4% and 58.7% respectively over the three rounds. The corresponding estimates in 12 to 18 year olds) were 70.7% and 34.6%, 85.6% and 45.9%, 89.0 and 53.9%. In November 2021 (before Omicron dominance), higher anti-S1 antibody positivity was associated with older age and Black ethnicity, and non- eligibility for free school meals in 4-11 year olds. In 12-18 years it was associated with non-eligibility for free school meals. In March 2022 when Omicron dominated, these associations remained, together with urban location in 4-11 years old. Conclusion(s): The steep increase in 4-11 year olds in both sets of antibodies reflected the emergence and spread of highly infectious Omicron variants whilst high and increasing anti-S1 prevalence in secondary students was consistent with greater vaccine uptake. Socioeconomically deprived 12-18 year olds had lower odds of anti-S1, suggesting lower vaccine uptake or access.Copyright © 2023

19.
Clin Exp Vaccine Res ; 12(2): 116-120, 2023 Apr.
Article in English | MEDLINE | ID: covidwho-2324979

ABSTRACT

Purpose: In Japan, the data on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody titers after the booster dose of the coronavirus disease 2019 (COVID-19) vaccine are insufficient. The aim of this study is to evaluate changes in SARS-CoV-2 antibody titers before, 1, 3, and 6 months after the booster dose of the BNT162b2 COVID-19 vaccine among health care workers. Materials and Methods: A total of 268 participants who received the booster dose of the BNT162b2 vaccine were analyzed. SARS-CoV-2 antibody titers were measured before (baseline) and at 1, 3, and 6 months after the booster dose. Factors associated with changes in SARS-CoV-2 antibody titers at 1, 3, and 6 months were analyzed. Cutoff values at baseline were calculated to prevent infection of the omicron variant of COVID-19. Results: The SARS-CoV-2 antibody titers at baseline, and 1, 3, and 6 months were 1,018.3 AU/mL, 21,396.5 AU/mL, 13,704.6 AU/mL, and 8,155.6 AU/mL, respectively. Factors associated with changes in SARS-CoV-2 antibody titers at 1 month were age and SARS-CoV-2 antibody titers at baseline, whereas changes in SARS-CoV-2 antibody titers at 3 and 6 months were associated with the SARS-CoV-2 antibody titers at 1 month. The cutoff values of the SARS-CoV-2 antibody titers at baseline were 515.4 AU/mL and 13,602.7 AU/mL at baseline and 1 month after the booster dose, respectively. Conclusion: This study showed that SARS-CoV-2 antibody titers increase rapidly at 1 month after the booster dose of the BNT162b2 vaccine and begin to decrease from 1 to 6 months. Hence, another booster may be needed as soon as possible to prevent infection.

20.
Russian Journal of Infection and Immunity ; 13(1):37-45, 2023.
Article in Russian | EMBASE | ID: covidwho-2320798

ABSTRACT

Introduction. The rapid spread of a new coronavirus infection among populations in many countries worldwide has contributed to the genetic evolution of the virus, resulting in the emergence of multiple genetic variants of the SARSCoV-2 coronavirus. Mutations in the viral genome can affect the ability of the virus to bypass the immune system and complicate development of diagnostic and prophylactic drugs. Data on the neutralizing activity of the sera obtained against previously circulating genetic variants of the virus in relation to current SARS-CoV-2 strains may serve as a scientific basis for the selection of the antigens in vaccine development. The aim of this work was to study cross-reactivity of SARSCoV-2 coronavirus strains belonging to different genetic variants, which were isolated in the territory of the Russian Federation during 2020-2022 in the neutralization reaction using mouse hyperimmune sera. Materials and methods. Ten strains of SARS-CoV-2 coronavirus belonging to different genetic variants were used (three non-VOC strains, alpha, beta, gamma, delta, delta+AY, omicron 1 and omicron 2). The hCoV-19/Australia/VIC01/2020 strain (Wuhan) was included in the study as a prototypical variant. BALBc mice were immunized with inactivated concentrated antigen mixed with a 1:1 adjuvant, which was a virus-like immunostimulatory complex based on Quillaja saponaria (Quillaja saponaria). The antibody titer was determined in the neutralization reaction. Results. Essential decrease of neutralizing ability of antibodies specific to non-vOC genetic variants of SARS-CoV-2 coronavirus was revealed against beta VOC and to a lesser degree against alpha and gamma VOC variants. The differences in the neutralizing activity level of antibodies for alpha and beta VOC variants are not significant among themselves, and with gamma VOC variants - there are no significant differences. Neutralizing ability of antibodies specific to delta VOC against alpha and beta VOC variants decreased 4-fold. Neutralizing activity of sera obtained to omicron 1 and 2 variants in relation to the prototype coronavirus variant was reduced 18-fold, to the gamma variant - 12-fold, to delta variants - more than 30-fold;for other variants it was even lower. Conclusions. The results obtained testify to the presence of cross-reactivity between strains of coronavirus belonging to genetic lines Wuhan, alpha, beta, gamma;it is weaker for delta variants. Mutations in the genome of VOC omicron variants led to a significant decrease in antigenic cross-links with earlier genetic variants of the coronavirus. These findings explain the low efficacy of vaccines based on the Wuhan strain, synthetic immunogens, and recombinant proteins based on it against omicron VOC variants, which have caused a rise in morbidity since early 2022, as well as cases of re-infection of humans with new genetic variants of the coronavirus.Copyright © 2023 Saint Petersburg Pasteur Institute. All rights reserved.

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