An Assessment of the Bivalent Vaccine as a Second Booster for COVID-19.
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ABSTRACT:
SUBMITTER: Gupta SL
PROVIDER: S-EPMC9863048 | biostudies-literature | 2022 Dec
REPOSITORIES: biostudies-literature
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An Assessment of the Bivalent Vaccine as a Second Booster for COVID-19.
Gupta Sneh Lata SL Jaiswal Rishi K RK
Vaccines 20221229 1
In the USA, two monovalent COVID-19 mRNA vaccines are primarily used for vaccination [...]. ...[more]
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Project description:BackgroundThe safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known.MethodsIn this ongoing, phase 2-3 study, we compared the 50-μg bivalent vaccine mRNA-1273.214 (25 μg each of ancestral Wuhan-Hu-1 and omicron B.1.1.529 [BA.1] spike messenger RNAs) with the previously authorized 50-μg mRNA-1273 booster. We administered mRNA-1273.214 or mRNA-1273 as a second booster in adults who had previously received a two-dose (100-μg) primary series and first booster (50-μg) dose of mRNA-1273 (≥3 months earlier). The primary objectives were to assess the safety, reactogenicity, and immunogenicity of mRNA-1273.214 at 28 days after the booster dose.ResultsInterim results are presented. Sequential groups of participants received 50 μg of mRNA-1273.214 (437 participants) or mRNA-1273 (377 participants) as a second booster dose. The median time between the first and second boosters was similar for mRNA-1273.214 (136 days) and mRNA-1273 (134 days). In participants with no previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the geometric mean titers of neutralizing antibodies against the omicron BA.1 variant were 2372.4 (95% confidence interval [CI], 2070.6 to 2718.2) after receipt of the mRNA-1273.214 booster and 1473.5 (95% CI, 1270.8 to 1708.4) after receipt of the mRNA-1273 booster. In addition, 50-μg mRNA-1273.214 and 50-μg mRNA-1273 elicited geometric mean titers of 727.4 (95% CI, 632.8 to 836.1) and 492.1 (95% CI, 431.1 to 561.9), respectively, against omicron BA.4 and BA.5 (BA.4/5), and the mRNA-1273.214 booster also elicited higher binding antibody responses against multiple other variants (alpha, beta, gamma, and delta) than the mRNA-1273 booster. Safety and reactogenicity were similar with the two booster vaccines. Vaccine effectiveness was not assessed in this study; in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster.ConclusionsThe bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.).
| S-EPMC9511634 | biostudies-literature
Project description:BackgroundBivalent booster mRNA vaccines containing the omicron-variant strains have been introduced worldwide in the autumn of 2022. Nevertheless, the omicron subvariants evoked another large coronavirus disease 2019 (COVID-19) pandemic wave in late 2022 and early 2023.MethodsA retrospective, test-negative, case-control study was conducted to estimate the vaccine effectiveness (VE) of bivalent COVID-19 vaccines in 8 university hospitals between January and February 2023. The case and control groups were divided based on nasopharyngeal COVID-19 real-time polymerase chain reaction results and matched based on age, sex, hospital, and date (week) of the test performed. The VE of the BA.1- or BA.4/BA.5-based mRNA vaccines were estimated. VE was calculated using the 1-adjusted odds ratio from multivariable logistic regression.ResultsIn total, 949 patients and 947 controls were enrolled in this study. VE for the BA.4/BA.5-based bivalent mRNA vaccine was 43% (95% confidence interval [CI], 17, 61%). In subgroup analysis based on age and underlying medical conditions, BA.4/BA.5-based bivalent mRNA vaccine was effective against old adults aged ≥ 65-years (VE, 55%; 95% CI, 23, 73%) and individuals with comorbidities (VE, 54%; 95% CI, 23, 73%). In comparison, the BA.1-based bivalent mRNA vaccine did not demonstrate statistically significant effectiveness (VE, 25%; 95% CI, -8, 49%).ConclusionThe BA.4/BA.5-based bivalent mRNA booster vaccine provided significant protection against COVID-19 in the Korean adults, especially in the older adults aged ≥ 65 years and in individuals with underlying medical conditions.
| S-EPMC10803207 | biostudies-literature
Project description:We previously presented day 29 interim safety and immunogenicity results from a phase 2/3 study (NCT04927065) comparing the Omicron-BA.1-containing bivalent vaccine mRNA-1273.214 (50-µg) to the 50-µg mRNA-1273 booster in adults who previously received the mRNA-1273 primary series (100-µg) and mRNA-1273 first booster (50-µg) dose. Primary endpoints were safety, non-inferiority of the neutralizing antibody (nAb) and seroresponse against Omicron BA.1, superiority of the nAb response against Omicron-BA.1, and non-inferiority of the nAb response against ancestral SARS-CoV-2 for second boosters of mRNA-1273.214 versus mRNA-1273 at days 29 and 91. The key secondary endpoint was the seroresponse difference of mRNA-1273.214 versus mRNA-1273 against ancestral SARS-CoV-2 at days 29 and day 91. Participants were sequentially enrolled and dosed with 50-µg of mRNA-1273 (n = 376) or mRNA-1273.214 (n = 437) as second booster doses. Here we present day 91 post-booster results. In participants with no pre-booster, severe acute respiratory syndrome coronavirus 2-infection (SARS-CoV-2), mRNA-1273.214 elicited Omicron-BA.1-nAb titers (95% confidence interval [CI]) that were significantly higher (964.4 [834.4-1114.7]) than those of mRNA-1273 (624.2 [533.1-730.9]) and similar to those of mRNA-1273 against ancestral SARS-CoV-2 at day 91. mRNA-1273.214 also induced higher binding antibody responses against Omicron BA.1 and alpha, gamma and delta variants than mRNA-1273. Safety profiles were similar for both vaccines. The Omicron-BA.1 bivalent vaccine improved antibody responses compared to mRNA-1273 through 90 days post-booster.
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Project description:Israel became the first country to offer the second COVID-19 booster vaccination. The study tested for the first time, the predictive role of booster-related sense of control (SOC_B), trust and vaccination hesitancy (VH) on adoption of the second-booster among older adults, 7 months later. Four hundred Israelis (≥60 years-old), eligible for the first booster, responded online, two weeks into the first booster campaign. They completed demographics, self-reports, and first booster vaccination status (early-adopters or not). Second booster vaccination status was collected for 280 eligible responders: early- and late-adopters, vaccinated four and 75 days into the second booster campaign, respectively, versus non-adopters. Multinomial logistic regression was conducted with pseudo R2 = .385. Higher SOC_B, and first booster early-adoption were predictive of second booster early-vs.-non-adoption, 1.934 [1.148-3.257], 4.861 [1.847-12.791]; and late-vs.-non-adoption, 2.031 [1.294-3.188], 2.092 [0.979-4.472]. Higher trust was only predictive of late-vs.-non-adoption (1.981 [1.03-3.81]), whereas VH was non-predictive. We suggest that older-adult bellwethers, second booster early-adopters, could be predicted by higher SOC_B, and first booster early-adoption, 7 months earlier.
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Project description:ObjectiveWe evaluated the immunogenicity of a bivalent BA.1 COVID-19 booster vaccine in people with HIV (PWH).DesignProspective observational cohort study.MethodsPWH aged ≥45 years received Wuhan-BA.1 mRNA-1273.214 and those <45 years Wuhan-BA.1 BNT162b2. Participants were propensity score-matched 1 : 2 to people without HIV (non-PWH) by age, primary vaccine platform (mRNA-based or vector-based), number of prior COVID-19 boosters and SARS-CoV-2 infections, and spike (S1)-specific antibodies on the day of booster administration. The primary endpoint was the geometric mean ratio (GMR) of ancestral S1-specific antibodies from day 0 to 28 in PWH compared to non-PWH. Secondary endpoints included humoral responses, T-cell responses and cytokine responses up to 180 days post-vaccination.ResultsForty PWH received mRNA-1273.214 ( N = 35) or BNT162b2 ( N = 5) following mRNA-based ( N = 29) or vector-based ( N = 11) primary vaccination. PWH were predominantly male (87% vs. 26% of non-PWH) and median 57 years [interquartile range (IQR) 53-59]. Their median CD4 + T-cell count was 775 (IQR 511-965) and the plasma HIV-RNA load was <50 copies/ml in 39/40. The GMR of S1-specific antibodies by 28 days post-vaccination was comparable between PWH [4.48, 95% confidence interval (CI) 3.24-6.19] and non-PWH (4.07, 95% CI 3.42-4.83). S1-specific antibody responses were comparable between PWH and non-PWH up to 180 days, and T-cell responses up to 90 days post-vaccination. Interferon-γ, interleukin (IL)-2, and IL-4 cytokine concentrations increased 28 days post-vaccination in PWH.ConclusionA bivalent BA.1 booster vaccine was immunogenic in well treated PWH, eliciting comparable humoral responses to non-PWH. However, T-cell responses waned faster after 90 days in PWH compared to non-PWH.
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Project description:To compare the effects of different types of SARS-CoV-2 vaccines in booster immunization, this study established a population cohort vaccinated with inactivated vaccine and protein subunit vaccine as the third booster vaccine, respectively. We collected serum and PBMC samples from participants in chronological order, and performed a systematic review of distinct antibody signatures and microtranscriptomics to provide data support for booster immunization.
2022-10-19 | GSE206023 | GEO
Project description:Aims and objectivesTo assess the levels of second COVID-19 booster dose/new COVID-19 vaccine hesitancy among nurses and explore the potential predictors of vaccine hesitancy.BackgroundCOVID-19 full vaccination seems to be highly effective against highly contagious variants of SARS-CoV-2. Healthcare workers are at high-risk group since they have experienced high levels of COVID-19-associated morbidity and mortality.DesignAn on-line cross-sectional study was carried out in Greece in May 2022, using a self-administered questionnaire.MethodsThe study population included nurses in healthcare services who were fully vaccinated against COVID-19 at the time of study. We considered socio-demographic characteristics, COVID-19-related variables, and attitudes toward COVID-19 vaccination and pandemic as potential predictors of vaccine hesitancy. We applied the STROBE checklist in our study.ResultsAmong 795 nurses, 30.9% were hesitant toward a second booster dose or a new COVID-19 vaccine. Independent predictors of hesitancy included lower educational level, absence of a chronic condition, good/very good self-perceived physical health, lack of flu vaccination during 2021, front-line nurses that provided healthcare to COVID-19 patients, nurses that had not been diagnosed with COVID-19 and nurses that had at least one relative/friend that has died from COVID-19. Moreover, increased compliance with hygiene measures, increased fear of a second booster dose/new COVID-19 vaccine and decreased trust in COVID-19 vaccination were associated with increased hesitancy.ConclusionsOur study shows that a significant percentage of nurses are hesitant toward a second booster dose/new COVID-19 vaccine. This initial hesitancy could be a barrier to efforts to control the COVID-19 pandemic.Relevance to clinical practiceNurses' role during the COVID-19 pandemic is essential since they are the front-line healthcare workers empowering the public with their passion and empathy. There is a need to communicate COVID-19 vaccine science in a way that is accessible to nurses in order to decrease COVID-19 vaccine hesitancy.Patient or public contributionNo patient or public contribution.
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