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Background: Coronavirus disease-2019 (COVID-19) poses expectant mothers to a higher risk of serious complications and mortality. Following a risk-benefit review, a number of governmental and professional bodies from across the globe recently approved the COVID-19 vaccination during pregnancy. Aim(s): This study aimed to investigate knowledge, actual acceptance, and concerns about the COVID-19 vaccine among the obstetric population. Material(s) and Method(s): Participants were selected from among the expecting women who came for antenatal checkup during the study period (October 1, 2021-November 30, 2021). About 150 pregnant women who met the inclusion criteria and consented were recruited into the study. Data related to socio-demographic and clinical characteristics as well as knowledge, actual acceptance, and concerns about COVID-19 vaccine were collected through in-person interviews using a prestructured questionnaire. The SPSS version 23 was used to analyze data. The association between the attitude (acceptance and hesitance) of participants toward the COVID-19 vaccine and their sociodemographic and clinical profile was found by Fisher's exact test. Result(s): The actual acceptance of the COVID-19 vaccine among expecting women was 52.0%. The primary motive for accepting COVID-19 immunization was to protect the fetus, followed by the protection of one's own health. A significant association was found between COVID-19 vaccine acceptance and the level of education, socio-economic status, and presence of comorbidities. The leading causes for vaccine reluctance were concerns about the efficacy and safety of the vaccines and lack of awareness about their usage during pregnancy. Conclusion(s): Multifaceted activities are required to promote the effectiveness and safety profile of the COVID-19 vaccine as well as disseminate knowledge about its usage during pregnancy. Clinical significance: Unlike numerous other studies that have investigated the accepting attitude only, the present one has investigated the actual COVID-19 vaccine uptake among the obstetric population.Copyright © The Author(s).
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Objective: To assess the course of COVID-19 infections and the tolerability of the mRNA vaccines of Moderna and Pfizer/BioNTech and the viral vector vaccines from Astra Zeneca and Johnson & Johnson in adult patients with epilepsy (PWE). Method(s): From July 2020 to July 2021, we consecutively included adult outpatients with confirmed epilepsy. These PWE were interviewed about COVID-19 infections and vaccinations. Results of follow-up visits were added until the cut-off date (December 31, 2021). The data of COVID-19-infected without vaccinations or fully vaccinated PWE without COVID-19 infections were analyzed. Full vaccination was defined as a double vaccination with the Pfizer/BionTech, Moderna, or Astra Zeneca vaccines or a single Johnson & Johnson vaccination. Result(s): At cut-off, 612 of 1152 PWE fulfilled the inclusion criteria: 51 PWE had been infected without vaccination and 561 had full vaccination without infection. Among the infected PWE, 76.5% presented with symptoms;9.8% had a severe course (one death). The leading symptoms were influenza-like disorders (48.7% of infected PWE with symptoms), anosmia (28.2%), and ageusia (20.5%). Seizure increases or relapses after sustained seizure freedom occurred in 7.8%. Adverse events (AEs) were reported by 113 vaccinated PWE (20.1% of all vaccinated PWE). The leading AEs were fatigue, fever, and headache. The AE rate per vaccine was 14.0% for Pfizer/BionTech, 32.7% for Moderna, 25.8% for Astra Zeneca, and 46.2% for Johnson & Johnson. Of the AEs, 93.3% lasted <=1 week. Seizure increase or relapse occurred in 1.4% and was significantly less frequent than in the infected group (p= 0.0016). Conclusion(s): The course of COVID-19 infections and the tolerability of the vaccines were similar as in the general population, yet, seizure worsening occurred more often after the infection than after the vaccination.Copyright © 2023, The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, part of Springer Nature.
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Glioblastoma is an extremely aggressive and difficult cancer to treat, which may partly be due to its limited ability to induce T-cell responses. However, combining viral vector vaccines with other therapies to generate tumor-specific T cells may provide a meaningful benefit to patients. Here, we investigated whether heterologous prime-boost vaccination with chimpanzee-derived adenoviral vector ChAdOx1 and modified vaccinia Ankara (MVA) vaccines could generate therapeutically effective CD8+ T-cell responses against a model antigen P1A, a mouse homolog of human tumorassociated Melanoma Antigen GenE (MAGE)-type antigens, expressed by a BGL-1 mouse glioblastoma cell line. We demonstrated that heterologous prime-boost vaccination with ChAdOx1/MVA vaccines targeting P1A generated a high magnitude of CD8+ T cells specific for the P1A35-43 epitope presented by the MHC class I molecule H-2Ld . Prophylactic vaccination with ChAdOx1/MVA-P1A significantly prolonged the survival of syngeneic mice subcutaneously challenged with P1A-expressing BGL-1 tumors. Furthermore, different vaccination schedules significantly impact the magnitude of antigen-specific CD8+ T-cell responses and may impact protective efficacy. However, the substantial induction of myeloid-derived suppressor cells (MDSCs) by this tumor model presents a significant challenge in the therapeutic setting. Future work will investigate the efficacy of this vaccination strategy on intracranial P1A-expressing BGL-1 models.
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Background: Coronavirus pandemic is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). WHO declared the outbreak as a Public Health Emergency of International Concern in January 2020 & a pandemic in March 2020. In India Oxford University-Astra Zeneca's Covishield vaccine, manufactured by serum institute of India and Bharath Biotech's Covaxin are being used for vaccination programme. In this study, we assess adverse reactions following Covid-19 vaccination & incidence of COVID-19 disease among vaccinated people across Kerala. Since it was newer vaccine and general population was afraid of side effects. The present study aimed to study the adverse effects of COVID-19 vaccination among general population aged above 18 years in Kerala. Method(s): A descriptive cross sectional study was conducted among COVID-19 vaccinated individuals above 18 yrs of age residing in Kerala from July 2021 to December 2021. Pattern of adverse events following COVID-19 vaccination (AEFI) were assessed using a semi structured questionnaire. An online questionnaire using Kobo Toolbox was developed and shared via online platform to record the self-reported adverse events following vaccination. A respondent driven sampling method was used. The data was downloaded in MS Excel and analysed using Microsoft excel. Result(s): Study was conducted among 526 people across Kerala, among which both males(45.63%) and females (54.18%). Majority of them received COVISHEID (92.97%) and rest of them received COVAXIN (6.24%) and SPUTNIK (0.57%). Out of which 65.97% received 2 doses and 34.03% received only one dose of vaccine. More than half of them (61.5%) faced side effects during post vaccination period. The symptoms were very mild in which fever (65.74%) and tiredness (76.85%) were the commonest symptoms. Conclusion(s): In the present study, majority of the vaccinated people experienced very mild and self limiting adverse effects, those were very mild & self limiting. It is a fact that COVID-19 vaccines doesn't provided 100% efficiency, but our study indicates that it does provides protection against COVID-19 infection to a great extend & breakthrough infections are very less severe and asymptomatic for vaccinated people.Copyright © 2023, Dr. Yashwant Research Labs Pvt. Ltd.. All rights reserved.
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Background: Healthcare workers (HCWs) in India are facing physical and psychological pressure. The pandemic has significant psychological impacts. Hence, we wanted to assess the mental stress and social stress among HCWs during the second wave of COVID-19. Aim and Objectives: Assessment of the mental distress among HCWs of tertiary care level institution during second wave of COVID-19 with the following objectives: (1) To know the sociodemographic characteristics of the HCWs of tertiary care center and (2) to assess the psychological stress among healthcare workers of a tertiary health center. Material(s) and Method(s): It is a cross-sectional and observational study conducted in hospital setting, in a tertiary care setting. Data were collected from 196 HCWs of the institute. Institutional ethical clearance was taken before the study. Structured questionnaire included sociodemographic variables, work-related variables, and variables to assess social stress. We used hospital anxiety and depression scoring questionnaire to assess anxiety and depression. Data were collected through personal interviews and online through Google forms after taking informed consent. Descriptive statistics and Chi-square tests are used analyzed using Statistical Package for the Social Sciences Version 21 for Statistical analysis. Result(s): A total of 196 HCWs, 121 doctors, 74 nursing staff, and one ward staff participated in the study. Nursing staff were at higher risk for anxiety and depression, that is, 29% and 25% than others. Females were slightly more anxious (29%) and depressed (17%) than males. HCWs who are Muslim by religion were at more mental distress. Media exposure of more than 3 h had increased risk of mental distress. HCWs with other frontline COVID warrior as a partner were both anxious (40%) and depressed (20%). Anxiety (35%) was more among those who's family members got COVID positive. About 25% of them faced social stigma, 55% of them faced issue of isolation with in the community, and 14% of them faced acts of violence which is unacceptable. Conclusion(s): Although its second wave HCWs are still having psychological distress which needs to be addressed. Social stress that they are facing is significant and is associated with higher anxiety and depression, which has to be taken seriously.Copyright © 2023, Mr Bhawani Singh. All rights reserved.
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The World Health Organization (WHO) declared an international public health concern on January 30, 2020, in response to the idiopathic Coronavirus disease 2019 (COVID-19) pandemic outbreak. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of the disease being identified as the third human Coronavirus, was discovered in Wuhan, Hubei Province, China. Coronavirus belongs to the Coronaviridae family, Coronavirinae subfamily which according to their genetic structures, are grouped into alphaCoronavirus (aCoV), betaCoronavirus (bCoV), gamma Corona¬virus (yCoV) and deltaCoronavirus (dCoV) of order Nidovirales. Coronaviruses are enveloped, positive-sense, single-stranded RNA viruses invading a wide variety of host species. SARS-CoV-2 belongs to extensively. Angiotensin¬converting enzyme 2 (ACE2) is imperative for Novel SARS-CoV-2 to enter host cells as a substrate receptor. With a high mortality rate in the elderly, immune-compromised, diabetic, and patients with cardiovascular and respiratory diseases, COVID-19 is an extremely contagious disease. Patients who are afflicted experience fever, a nonproductive cough, lethargy, dyspnea, and occasionally diarrhoea as well as radiographic signs of pneumonia. A cytokine storm is a result of the immune system's aggressive response to a virus that has propagated inside the body. Genetic recombination and mutation are the main drivers of the emergence of novel SARS-CoV-2 variants. Variants of concern (VOCs) are used to describe some variants having significant virulence and transmission rates, such as the Omicron variants now. RT-LAMP, RT- qPCR, and High-Resolution Computed Tomography, among other new cutting-edge techniques, are effective at diagnosing SARS-CoV-2 infected patients. Standard treatments involving compounds like Lopinavir/Ritonavir, paxlovid, and molnupiravir have shown to be efficacious to some extent against even the newly emerging strains when it comes to treatment approaches. Additionally, immunization is a crucial strategy for preventing the disease or lessening its impact. Live attenuated vaccines, DNA- and RNA-based vaccines, protein subunit vaccines, and amplifying viral vector vaccines are among the molecular frameworks used in the production of vaccines against SARS-CoV-2. Comirnaty by Pfizer-BioNTech, SpikeVax by Moderna, and Vaxzevria by Oxford- AstraZeneca are three extensively incorporated and validated COVID-19 vaccines. In a similar vein, a variety of vaccinations have been created with varying degrees of potency against VOCs. Nanotechnology and artificial intelligence (AI) advancements may help in the provision of an effective and dependable remedy for the eradication of SARS-CoV-2. Definitive diagnosis, community engagements, and united scientific approaches have effectively addressed public health issues amid the pandemic. Although COVID-19 has presented a significant challenge to the healthcare system, it has also provided a chance for the development of novel and creative roles that could have significant effects on the healthcare system. This pandemic has highlighted the value of prompt diagnosis, the value of universal healthcare as well as the need for cutting-edge methods to contain pandemics around the world. © 2023 Nova Science Publishers, Inc. All rights reserved.
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Background: People with chronic diseases of the immune system, such as multiple sclerosis (MS), are at risk for Covid-19 disease. However, more research is needed with long-term follow-up. The aim of the study was to follow up people with MS (PwMS) for up to three months after AstraZeneca vaccination for the recurrence of MS and Covid-19 infection. Method(s): This study was a case study (descriptive-analytical) of follow-up type. The study population was PwMS over 18 years of age in Kermanshah province who received both doses of the AstraZeneca vaccine. This study was conducted from August to November 2021. Sampling was done with existing methods based on the National MS Registry of Iran (NMSRI). Demographic information of patients was extracted from NMSRI. A researcher-made form was used to collect information by telephone three months after vaccination about clinical characteristics, Covid-19 infection, and recurrence of MS. Data were analyzed using SPSS-25 software. Result(s): Study participants were 40 MS patients with a mean (SD) age of 39.27 (8.8) years, including 32 (80.0%) women. A mean of 9.39 (4.6) years had passed since The patients were diagnosed with MS, and 29 (76.4%) had RR type MS. Four patients (10%) relapsed between the second dose and three months later, of whom two (50%) had sensory symptoms, one (25%) had optic nerve involvement, and one (25%) had motor symptoms and pyramidal pathway involvement. The symptoms of Covid-19 were mild in three patients (10%), while severe symptoms developed in one patient (10%) who received rituximab. Among the patients, no cases of thrombosis were observed. Infusion therapy, a leg fracture, and kidney stones were the only hospitalized cases. Conclusion(s): Covid-19 and MS relapse prevalence did not differ significantly in the three months before and after vaccination. There is a need for further studies with a longer follow-up period.Copyright © 2022 Razazian et al. Published by Tehran University of Medical Sciences.
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Background: Patients with cancer are at a higher risk of severe forms of coronavirus disease 2019 (COVID-19) and mortality. Therefore, widespread COVID-19 vaccination is required to attain herd immunity. Objective(s): We aimed to evaluate the uptake of the COVID-19 vaccine in Indian patients with cancer and to collect information regarding vaccine hesitancy and factors that contributed to vaccine hesitancy. Material(s) and Method(s): This was a questionnaire-based survey conducted between May 7, 2021 and June 10, 2021 in patients aged 45 years and over, with solid tumors. The primary end points of the study were the proportion of Indian patients with cancer aged 45 years and older who had not received the COVID-19 vaccine, and the reasons why these patients had not received the COVID-19 vaccine. Our secondary end points were the proportion of patients with a history of COVID-19 infection, and the proportion of the patients who had vaccine hesitancy. Additionally, we attempted to assess the factors that could impact vaccine hesitancy. Result(s): A total of 435 patients were included in the study. Of these, 348 (80%) patients had not received even a single dose of the COVID-19 vaccine;66 (15.2%) patients had received the first dose, and 21 (4.8%) had received both the doses. Approximately half (47.1%) of the patients reported that they took the COVID-19 vaccine based on the advice from a doctor. The reasons for not taking the COVID-19 vaccine could be considered as vaccine hesitancy in 259 (77%) patients. The two most common reasons were fear in 124 (38%) patients (fear of side-effects and of the impact of the vaccine on the cancer/therapy) and lack of information in 87 (26.7%) patients. On the multivariate analysis, the two factors found to be significantly associated with vaccine hesitancy were a lower educational level (OR, 1.78;95% CI, 1-3.17;P = 0.048) and a lack of prior advice regarding the COVID-19 vaccine (OR, 2.80;95% CI, 1.73-4.53;P < 0.001). Conclusion(s): Vaccine hesitancy is present in over half of our patients, and the most common reasons are a fear of the vaccine impacting the cancer therapy, fear of side-effects, and lack of information. Widespread vaccination can only be attained if systematic programs for education and dissemination of information regarding the safety and efficacy of the COVID-19 vaccine are given as much importance as fortification of the vaccination supply and distribution system.Copyright © 2021 Cancer Research, Statistics, and Treatment Published by Wolters Kluwer - Medknow.
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Worldwide, infectious diseases have contributed significantly to morbidity and mortality;among the leading causes of death are pneumonia, respiratory infections and Covid-19. Stem cell therapy will be used to treat virus-infected patients in an effective and safe manner. A cross-sectional questionnaire was used to collect data from doctors. Most doctors are aware of the applications of stem cells, but they do not confirm their usage because clinical trials are ongoing. Instead, they show support for using stem cells to treat patients. Stem cells have been hoping to help repair damaged tissues in the respiratory system to promote faster recovery. Stem Cells are being studied in current clinical trials for their efficacy and safety in virus severe pneumonia and respiratory infections. The doctors suggested that stem cells have been used in infectious diseases to improve their health.Copyright © 2023 Health Biotechnology And Biopharma. All rights reserved.
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Introduction: Side effects related to COVID-19 vaccination are short-lived and disappear within a few days and can affect both pregnant and nonpregnant women. Aim(s): To evaluate the bibliometric profile of the worldwide scientific production on the side effects of COVID-19 vaccine in pregnant women, in Scopus. Material(s) and Method(s): A retrospective, cross-sectional, bibliometric study that analyzed metadata published in scientific journals indexed in Scopus during 2019 and 2021. The search and download of the papers were performed on May 13, 2022, and the SciVal program was used for the measurement of the bibliometric indicators. Result(s): The Lancet Infectious Diseases and International Journal of Gynecology and Obstetrics had the highest impact with 24.8 and 14.3 citations per publication, respectively. The institutions with the highest number of papers were Harvard University and National Institutes of Health, with 13 papers, respectively. Goldfarb Ilona Telefus, Kampmann Beate, and Khalil Asma were the authors with the highest number of papers, with 3 each. Only one publication on the side effects of COVID-19 vaccine in pregnant women was identified in 2019, whereas the highest scientific output was identified in 2021, with 127, of which 67 were from Q1. Conclusion(s): In Scopus, there is an increase in the production of papers on the side effects of the vaccine against COVID-19 in pregnant women, with the United States being the country with the most institutions with the highest scientific production. However, over the years, the quartile of the journals where these studies were published decreased.Copyright © The Author(s).
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OBJECTIVE: To investigate the association of immune response with vaccination adverse effects at peak anti-receptor-binding domain spike subunit 1 (anti-RBDS1) IgG after full vaccination with Comirnaty, Spikevax, or Vaxzevria. METHODS: Anti-RBDS1 IgG concentrations after vaccination were determined in healthy adults vaccinated with the Comirnaty, Spikevax, and Vaxzevria vaccines. The association of reactogenicity and peak antibody response after vaccination was tested. RESULTS: Anti-RBDS1 IgG values were significantly higher in the Comirnaty and Spikevax group, compared with the Vaxzevria group (P < .001). Fever and muscle pain were found to be significant independent predictors of peak anti-RBDS1 IgG in the Comirnaty and Spikevax groups (P = .03 and P = .02, respectively). The multivariate model, adjusted for covariates, showed that no association between reactogenicity and peak antibody concentrations was found in the Comirnaty, Spikevax, and Vaxzevria groups. CONCLUSIONS: No association between reactogenicity and peak anti-RBDS1 IgG after vaccination with the Comirnaty, Spikevax, and Vaxzevria vaccine was found.
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Objectives: Few studies evaluate the immunogenicity and safety of different COVID-19 vaccine platforms in patients with primary Sjogren's Syndrome (pSS). The present study aims to assess the immunogenicity through anti-spike IgG antibodies after the COVID-19 vaccine dose in heterologous groups compared to homologous regimen in patients with pSS. Method(s): These data are from the SAFER study: 'Safety and efficacy of the COVID-19 vaccine in rheumatic disease', a real-life phase IV multicenter longitudinal study, evaluating patients since before the first dose. Pregnant women, those with a history of serious adverse events prior to any vaccine, and those with other causes of immunosuppression were excluded. Patients with pSS > 18 years, classified according to ACR/EULAR 2016 classification criteria were included. Antibodies against the Receptor Binding Domain - RBD portion of the Spike protein of SARS-CoV-2 (IgG-S) were measured by chemiluminescence (Architect SARS-CoV-2 Quanti II, Abbott), before the first dose and 28 days after the 2nd and 3rd dose. Seropositivity was defined as IgG-Spike titers >=7.1 BAU/mL. Patients received adenoviral vector (ChAdOx1, Astrazeneca), mRNA (Pfizer) or inactivated SARS-COV-2 (Coronavac). Non-parametric methods were used. The alpha level of significance was set at 5%. Result(s): 56 participants received 3 doses, 46 +/- 11 years old, disease duration 7.62 years, 92.9% female, 41.1% White and 55.4% Mixed. The homologous third-booster dose group (n = 15, all ChAdOx1) and heterologous group (n = 41) were homogeneous for age, sex, ethnicity, comorbidities, medication and baseline IgG-S median [IQR] titers. After primary vaccination (2 doses) IgG-S median and titers [IQR] were similar in homologous and heterologous groups (373.03 [179.58, 843.92] vs. 473.36 [119.05, 1059.60], p = 0.705). Third-booster dose induced higher IgG-S median [IQR] titers compared to only 2 doses (1229.54 [333.55, 4365.47] vs 464.95 [140.42, 1015.25], p alpha 0.001). Heterologous 3rd-booster induced higher IgG-S median [IQR] titers than homologous scheme with ChAdOx1 (1779.52 [335.83, 4523.89] vs 730.76 [303.37, 1858.98], p = 0.150), Fig 1 and 2, although not statistically significant. Conclusion(s): Third booster dose induced higher humoral immune response compared to two doses whichmay improve protection against COVID-19 in patients with pSS. Although not statistically significant, the response to the heterologous scheme tended to be better than the response to the homologous booster vaccination, which heterologous booster scheme tended to respond better than homologous booster vaccination, which is relevant in this immunosuppressed population. Increasing the sample size will help clarify this issue. .
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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
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Objectives: Patients with immune-mediated diseases achieve lower seroconversion rates to COVID19 vaccines compared to healthy controls. The aim of this study was to assess the SARS-CoV-2-specific humoral and T-cell responses after a two-dose regimen of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA). Method(s): Observational study. Patients with RA, >=18 years of age, who were vaccinated according to the Argentine National Health Ministry's vaccination strategy were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity and specific T-cell responses were assessed after the first and second doses. Result(s): A total of 120 RA patients were included. Mostly, homologous regimens were used, including Gam-COVID-Vac (27.5%), ChAdOx1 (24.2%), BBIBP-CorV (22.5%) and BNT162b2 (0.8%), while the most frequent combination of vaccines was Gam-COVID-Vac/mRNA-1273 (21.7%). After the second dose 81.7% presented anti-SARS-CoV-2 antibodies, 70.0% neutralizing activity and 65.3% specific T-cell response. The use of BBIBP-CorV, treatment with abatacept (ABA) and rituximab (RTX) were associated with undetectable antibodies and no neutralizing activity after two doses of vaccine. BBIBP-CorV was also associated with the absence of T-cell response. The total incidence of adverse events was 357.1 events/1000 doses: significantly lower with BBIBP-CorV (166.7 events/1000 doses, p alpha 0.02). Conclusion(s): In this cohort of patients with RA who received 2 doses of COVID-19 vaccine, according to the Argentine strategic vaccination planwhich included homologous and heterologous regimens, two of ten did not develop IgG anti-SARS-CoV-2, 70% presented neutralizing activity and 65% specific T-cell response. The use of BBIBP-CorV was associated with deficient humoral and cellular response, while treatment with ABA and RTXaffected the development of IgG anti-SARS-CoV-2 and neutralizing activity.
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Objectives: To evaluate the safety and immunogenicity of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with Rheumatoid Arthritis (RA). Method(s): These data are from the 'SAFER (Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases)' study, a Brazilian multicentric longitudinal phase IV study to evaluate COVID-19 vaccine in immunomediated rheumatic diseases (IMRDs). Adverse events (AEs) in patients with RA were assessed after two doses of ChAdOx1 or CoronaVac. Stratification of postvaccination AEs was performed using a diary, filled out daily. The titers of neutralizing antibodies against the receptor-biding domain of SARS-CoV-2 (anti-RBD) were measured by chemilumine scence test after each dose of immunizers. Proportions between groups were compared using the Chi-square and Fisher's exact tests for categorical variables. Clinical Disease Activity Index (CDAI) before and after vaccination was assessed using the McNemar test. Result(s): A total of 188 patients with RA were included in the study, most of them were female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed. The more common AEs after the first dose were pain at injection site (46,7%), headache (39,4%), arthralgia (39,4%) and myalgia (30,5%), and ChAdOx1 had a higher frequency of pain at the injection site (66% vs 32 %, p alpha 0.001) arthralgia (62% vs 22%, p alpha 0.001) and myalgia (45% vs 20%, p alpha 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection site (37%), arthralgia (31%), myalgia (23%) and headache (21%). Arthralgia (41,42 % vs 25 %, p = 0.02) and pain at injection site (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. No patients had a flare after vaccination. The titers of anti-RBDafter two doses of ChAdOx1 were higher compared to two doses of CoronaVac (6,03 BAU/mL vs 4,67 BAU/mL, p alpha 0,001). Conclusion(s): The frequency of local adverse effects, particularly pain at injection site, was high. AEs were more frequent with ChAdOx1, especially after the first dose. The use of the immunizers dis not change the degree of inflammatory activity of the disease. In patients with RA, ChAdOx1 was more immunogenic than CoronaVac. .
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Objectives: To evaluate the humoral immune response to the third dose (booster) of vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases who were seronegative after a two-dose regimen. Method(s): Observational study. Patients with autoimmune rheumatic diseases who had not achieved seroconversion after a two-dose vaccine schedule against SARS-CoV-2 were included. To assess the humoral immune response, anti-RBD IgG (S protein receptor binding domain) neutralizing antibody titers were determined by ELISA (cutoff titer 200). The determination was made between 30 to 45 days after the third dose. Result(s): From 66 patients who received SARS-CoV-2 vaccination, 18 patients (29.5%) were seronegative after a two-dose schedule. 61% had SLE, 77% had comorbidities (61% with hypertension, p = 0.03). Patients were on treatment: 10 with prednisone (8 with doses greater than 10 mg/d, p = 0.01), 10 with hydroxychloroquine, one with methotrexate, one with leflunomide, four with azathioprine, five with my cophenolatemofetil and five with rituximab (they are the total number of non-responders on biological treatment, p = 0.03). Regarding the primary vaccination regimen, 11 received BBIBP-CorV (p = 0.01), 5 AZD1222, 1 Gam-COVID-Vac and 1 mRNA1273/Gam-COVID-Vac heterologous scheme. Of these 18 non-responders, 14 received a third dose;nine patients (62%) presented anti-RBD IgG detectable. Of the five patients who did not respond to the booster vaccination, three had received BBIBP-CorV as the initial schedule and the vaccines applied as a third dose were Ad5-nCoV (1), BNT162b2 (1), AZD 1222 (2) and Gam-COVID-Vac (1). They were being treated with: rituximab (2), azathioprine (2) and mycophenolate mofetil (1). Treatment with higher doses of prednisone was the only factor associated with non-seroconversion to the third dose (8 +/- 4.5;p 0.02). Conclusion(s): The third dose of SARS-CoV-2 vaccine allowed to improve the serological response to vaccination, achieving a seroconversion of 62% in this group of patients.
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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. .
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