Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Vaccines, Journal Year: 2024, Volume and Issue: 12(3), P. 241 - 241

Published: Feb. 26, 2024

In all pivotal trials of COVID-19 vaccines, the history previous SARS-CoV-2 infection was mentioned as one main exclusion criteria. absence clinical trials, observational studies are primary source for evidence generation. This study aims to describe patient-reported adverse drug reactions (ADRs) following first vaccination cycle, well administration booster doses different vaccine brands, in people with prior infection, compared infection-free matched cohorts vaccinees. A web-based prospective conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries period February 2021–February 2023. baseline questionnaire and up six follow-up collected data on vaccinee’s characteristics, solicited unsolicited reactions. Overall, 3886 902 vaccinees having received dose or a dose, respectively, were included analysis. After reported at least ADR higher frequency than those without (3470 [89.6%] vs. 2916 [75.3%], 614 [68.2%] 546 [60.6%], respectively). On contrary side, after second lower frequency, controls (1443 [85.0%] 1543 [90.9%]). The median time onset recovery similar across cohorts. individuals who Vaxzevria Spikevax doses. serious ADRs low Data this large-scale could be used inform likelihood effects based their age, sex, type administered. line safety profile vaccines also confirmed infection.

Language: Английский

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Durability of ChAdOx1 nCoV-19 (AZD1222) vaccine and hybrid humoral immunity against variants including omicron BA.1 and BA.4 6 months after vaccination (COV005): a post-hoc analysis of a randomised, phase 1b–2a trial

The Lancet Infectious Diseases, Journal Year: 2022, Volume and Issue: 23(3), P. 295 - 306

Published: Oct. 20, 2022

BackgroundCOVID-19 vaccine rollout is lagging in Africa, where there has been a high rate of SARS-CoV-2 infection. We aimed to evaluate the effect infection before vaccination with ChAdOx-nCoV19 (AZD1222) on antibody responses through 180 days.MethodsWe did an unmasked post-hoc immunogenicity analysis after first and second doses AZD1222 randomised, placebo-controlled, phase 1b–2a study done seven locations South Africa. recipients who were HIV-uninfected, stratified into baseline seropositive or seronegative groups using serum anti-nucleocapsid (anti-N) immunoglobulin G (IgG) electroluminescence immunoassay establish dose AZD1222. Binding IgG spike (anti-S) receptor binding domain (anti-RBD) measured (day 0), 28), day 42, 180. Neutralising (NAb) against variants D614G, beta, delta, gamma, A.VOI.V2, omicron BA1 BA.4 variants, by pseudovirus assay 28, 180). This trial registered ClinicalTrials.gov, NCT04444674, Pan African Clinicals Trials Registry, PACTR202006922165132.FindingsOf 185 individuals randomly assigned AZD1222, we included 91 58 seronegative, final analysis. In group, was little change anti-S (and anti-RBD IgG) neutralising titres at 42 compared 28. Anti-S anti-RBD) geometric mean concentrations (GMCs) higher throughout including (GMCs 517·8 [95% CI 411·3–651·9] vs 82·1 [55·2–122·3] BAU/mL). Also D614G NAb (GMTs) group than as percentage least (80% putative risk reduction threshold [PRRT] wild-type–alpha COVID-19), (92·0% [74·0–99·0] 18·2% [2·3–51·8). Similar findings observed for gamma. For BA.1, BA.4, GMTs proportion above PRRT substantially 28 but no longer differed between 180.InterpretationA single general population, COVID-19 coverage low seropositivity 90%, could enhance magnitude quality SARS-CoV-2.FundingThe Bill & Melinda Gates Foundation, Medical Research Council, UK Innovation, National Institute Health Research, Council.TranslationFor Zulu translation abstract see Supplementary Materials section.

Language: Английский

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Durable immune responses after BNT162b2 vaccination in home-dwelling old adults

Vaccine X, Journal Year: 2023, Volume and Issue: 13, P. 100262 - 100262

Published: Jan. 10, 2023

Elderly are an understudied, high-risk group vulnerable to severe COVID-19. We comprehensively analyzed the durability of humoral and cellular immune responses after BNT162b2 vaccination SARS-CoV-2 infection in elderly younger adults.

Language: Английский

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Unpacking the Implications of SARS-CoV-2 Breakthrough Infections on COVID-19 Vaccination Programs

Vaccines, Journal Year: 2022, Volume and Issue: 10(2), P. 252 - 252

Published: Feb. 7, 2022

Despite an array of preventive global public health interventions, SARS-CoV-2 has continued to spread significantly, infecting millions people across the globe weekly. Newer variants interest and concern have emerge, placing need for policymakers rethink prevention strategies end pandemic. The approval vaccines use in December 2020 was seen as a significant development towards pandemic control possibly ending However, breakthrough infections be observed among 'fully vaccinated', duration sustainability vaccine-induced immunity remained topical discourse. In absence accurate communication, waning concepts potential further compound vaccine hesitancy. With this viewpoint, we discuss infections, immunity, COVID-19 booster shots, inequities, address hesitancy adequately propel vaccination programs forward.

Language: Английский

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Effects of SARS-CoV-2 vaccination on the severity of COVID-19 infection in patients on chronic dialysis

Journal of Nephrology, Journal Year: 2023, Volume and Issue: 36(5), P. 1321 - 1328

Published: April 5, 2023

Language: Английский

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Safety, immunogenicity, and breakthrough infections during 1-year follow-up after COVISHIELD™ vaccination among healthcare workers in a teaching institute in North India: A prospective longitudinal study

Journal of Family Medicine and Primary Care, Journal Year: 2025, Volume and Issue: 14(2), P. 655 - 661

Published: Feb. 1, 2025

A prospective longitudinal study was planned to assess immunogenicity, safety, and breakthrough infection rates among health care workers (HCWs) after COVISHIELD™ vaccination in a teaching institute North India. total of 518 HCWs were enrolled at baseline for receiving first dose COVISHIELD™, 429 continued participation second dose, 415 followed up 28 days 405 6 months, 403 1 year from February 2021 November 2022. At each visit prior, 2 ml blood sample collected plasma separated. Anti-SARS-Cov-2 IgG antibodies against spike protein detected by Chemiluminescent Immuno-Assay on the VITROS 3600 platform (Ortho-clinical Diagnostics, NJ, USA). Data analysed (completed all follow-ups), using Statistical Package Social Sciences version 21.0. The mean age participants 35.3 years (SD ± 11.11), males 50.2%. (N = 518), proportion reactive 25% (95% CI, 21-29%), which increased significantly 92% 89-95%) 403), 95% 92-96%) declined 85% 83-93%) six months 403). year, reactivity 89.3% 86-90%; P value < 0.0001). Fever reported 31.2% HCWs, pain injection site (27.6%), malaise (16.4%), headache (3.7%), dizziness (3.7%). Immunogenicity post-COVISHIELD™ doses but inclined dose. safety profile within acceptable limits.

Language: Английский

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SARS-Cov-2 vaccination strategies in hospitalized recovered COVID-19 patients: a randomized clinical trial (VATICO Trial)

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: March 22, 2025

The impact on immunogenicity and efficacy of SARS-CoV-2 vaccination in people with prior COVID-19 could differ depending timing number doses. VATICO study randomized 66 hospitalized recovered individuals to receive either immediate or deferred vaccination, one two doses mRNA vaccines. We measured binding neutralizing antibodies against at enrollment longitudinally. Median (IQR) time from infection first was 68 (53–75) days the group, 151 (137–173) group. At week 48, vaccine did not influence change antibody levels relative baseline. Adherence assigned regimen lower particularly participants receiving Although ultimately lacked adequate power draw firm conclusions, these results suggest possible benefits prompt after recovery COVID-19.

Language: Английский

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Modelling SARS-CoV-2 Binding Antibody Waning 8 Months after BNT162b2 Vaccination

Vaccines, Journal Year: 2022, Volume and Issue: 10(2), P. 285 - 285

Published: Feb. 13, 2022

Several lines of evidence suggest that binding SARS-CoV-2 antibodies such as anti-SARS-CoV-2 RBD IgG (anti-RBD) and neutralising (NA) are correlates protection against SARS-CoV-2, the correlation anti-RBD NA is very high. The effectiveness (VE) BNT162b2 in preventing infection wanes over time, this reduction mainly associated with waning immunity, suggesting kinetics might be interest to predict VE. In a study 97 health care workers (HCWs) vaccinated vaccine, we assessed 30-250 days after vaccination using 388 individually matched plasma samples. Anti-RBD levels declined by 85%, 92%, 95% at 4th, 6th, 8th month from peak, respectively. were estimated trajectories various models. restricted cubic splines model had better fit observed data. declines statistically significantly lower for risk factors severe COVID-19 absence side effects. Moreover, previous was divergent consistent slower decline time. These results may serve harbinger vaccine (VE), it should explored predictor breakthrough infections

Language: Английский

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High avidity of vaccine-induced immunoglobulin G against SARS-CoV-2: potential relevance for protective humoral immunity

Exploration of Immunology, Journal Year: 2022, Volume and Issue: unknown, P. 133 - 156

Published: March 16, 2022

Avidity of immunoglobulin G (IgG) is defined as its binding strength to target antigen. As a consequence affinity maturation the IgG response, avidity maturing well. Therefore, acute infections are characterized by low-avidity IgG, whereas past usually associated with high-avidity IgG. also observed optimal vaccination. has been shown play significant role in protective humoral immunity many microbial systems. After severe respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, situation different compared other viral infections, moderate degree reached most cases infection similar that after only one vaccination step. In contrast, two steps lead much higher directed towards spike protein S1 (S1) majority vaccinated individuals. it seems allow for more extended affinity/avidity than natural infection. The heterogeneous. It can be further enhanced third Complete depend on sustained availability antigen during process. Variants concern seem increase their receptor-binding domain (RBD) angiotensin-converting enzyme-2 (ACE2) and/or decrease susceptibility neutralizing antibodies. Classical neutralization tests do not necessarily reflect they operationally dissect reaction between and from ACE2. This approach fades out critical competition reactions ACE RBD S1. Quantitative determination might an essential tool define individuals possess suboptimal therefore benefit additional booster immunization.

Language: Английский

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Anti‐spike IgG antibody kinetics following the second and third doses of BNT162b2 vaccine in nursing home residents

Journal of the American Geriatrics Society, Journal Year: 2022, Volume and Issue: 70(9), P. 2552 - 2560

Published: April 29, 2022

Duration of post-vaccination protection against COVID-19 in nursing home (NH) residents is a critical issue. The objective this study was to estimate the duration IgG(S) response mRNA BNT162b2 vaccine NH with (COV-Yes) or without (COV-No) history SARS-CoV-2 infection.A 574 COV-Yes and COV-No were included 2 cohorts: Main (n = 115, median age 87 years) Confirmatory 459, 89 years). quantification carried out at three different time points following vaccine: (1st) seven (2nd) months after 2nd dose, 1 month 3rd dose (3rd quantification) cohort, twice (2nd 3rd) cohort. seroneutralization capacity according also measured subgroup patients.Neutralization strongly correlated levels (R2 :76%) any difference between groups for same IgG(S). After assumed robust (IgG(S) >264 BAU/ml) two-fold higher vs. group: 12.60 (10.69-14.44) versus 5.76 (3.91-8.64) months, advantage mainly due titers secondary slower decay over time. estimated 11.87 (9.88-14.87) 8.95 (6.85-11.04) months. These results similar both cohorts.In old subjects living NH, infection provides clear magnitude high dose. Importantly, induces much more pronounced than subjects, effect which should be able ensure prolonged severe forms these subjects.

Language: Английский

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