Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variants
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Abstract
This is a comprehensive report on immunogenicity of COVAXIN ® booster dose against ancestral and Variants of Concern (VOCs) up to 12 months. It is well known that neutralizing antibodies induced by COVID-19 vaccines wane within 6 months of vaccination leading to questions on the effectiveness of two-dose vaccination against breakthrough infections. Therefore, we assessed the persistence of immunogenicity up to 6 months after a two or three-dose with BBV152 and the safety of a booster dose in an ongoing phase 2, double-blind, randomized controlled trial (ClinicalTrials.gov: NCT04471519). We report persistence of humoral and cell mediated immunity up to 12 months of vaccination, despite decline in the magnitude of antibody titers. Administration of a third dose of BBV152 increased neutralization titers against both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) with a slight increase in B cell memory responses. Thus, seronversion rate remain high in boosted recipients compared to non-booster, even after 6 months, post third dose against variants. No serious adverse events observed, except pain at the injection site, itching and redness. Hence, these results indicate that a booster dose of BBV152 is safe and necessary to ensure persistent immunity to minimize breakthrough infections of COVID-19, due to newly emerging variants.
Trial registration: Registered with the Clinical Trials Registry (India) No. CTRI/2021/04/032942, dated 19/04/2021 and on Clinicaltrials.gov: NCT04471519.
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SciScore for 10.1101/2022.01.05.22268777: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was approved by the National Regulatory Authority (India) and the respective hospital Ethics Committees and conducted in compliance with all International Council for Harmonization (ICH) Good Clinical Practice guidelines.
Consent: Following an amendment to the protocol 6 months after dose 2, new informed consent was obtained from participants who originally received the 6 µg dose of BBV152, including some who had “dropped out” of the parent study.Sex as a biological variable Trial Design and Participants: The parent study was a randomised, double-blind, multicentre phase 2 trial to evaluate the immunogenicity and safety of a whole-virion inactivated SARS-CoV-2 vaccine (BBV152) … SciScore for 10.1101/2022.01.05.22268777: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was approved by the National Regulatory Authority (India) and the respective hospital Ethics Committees and conducted in compliance with all International Council for Harmonization (ICH) Good Clinical Practice guidelines.
Consent: Following an amendment to the protocol 6 months after dose 2, new informed consent was obtained from participants who originally received the 6 µg dose of BBV152, including some who had “dropped out” of the parent study.Sex as a biological variable Trial Design and Participants: The parent study was a randomised, double-blind, multicentre phase 2 trial to evaluate the immunogenicity and safety of a whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy male and female volunteers in nine Indian hospitals [7]. Randomization Trial Design and Participants: The parent study was a randomised, double-blind, multicentre phase 2 trial to evaluate the immunogenicity and safety of a whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy male and female volunteers in nine Indian hospitals [7]. Blinding Peripheral blood mononuclear cells (PBMC) were collected from a subset of participants randomly selected using a code from the CRO and assessed SARS-CoV-2-specific T and B cell memory responses on Days 215 243 in a blinded manner at Immunitas Biosciences (Bengaluru, India) Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Outcomes: The primary endpoints were neutralising antibody titres against wild-type virus evaluated by two neutralisation assays; a plaque-reduction neutralisation test (PRNT) and a microneutralisation assay (MNT) done at Bharat Biotech laboratories (Hyderabad, India) as previously described [7–9]. MNTsuggested: NoneIgG-binding antibody binding titres were determined by ELISA against the SARS-CoV-2 specific proteins: Spike protein (S1), receptor-binding domain (RBD) and nucleocapsid protein (N). S1) , receptor-binding domain ( RBD ) and nucleocapsid protein ( N) .suggested: NoneFinally, we assessed for a Th1 biased immune response based on the ratio of IgG1 and IgG4 endpoint antibody titres in placebo and vaccine recipients on Days 215 and 243. IgG4suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04471519 Active, not recruiting Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COV… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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