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      Booster shot of inactivated SARS‐CoV‐2 vaccine induces potent immune responses in people living with HIV

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          Abstract

          This study aimed to investigate the immunogenicity to SARS‐CoV‐2 and evasive subvariants BA.4/5 in people living with HIV (PLWH) following a third booster shot of inactivated SARS‐CoV‐2 vaccine. We conducted a cross‐sectional study in 318 PLWH and 241 healthy controls (HC) using SARS‐CoV‐2 immunoassays. Vaccine‐induced immunological responses were compared before and after the third dose. Serum levels of IgG anti‐RBD and inhibition rate of NAb were significantly elevated at the “post‐third dose” sampling time compared with the pre‐third dose in PLWH, but were relatively decreased in contrast with those of HCs. Induced humoral and cellular responses attenuated over time after triple‐dose vaccination. The neutralizing capacity against BA.4/5 was also intensified but remained below the positive inhibition threshold. Seropositivity of SARS‐CoV‐2‐specific antibodies in PLWH was prominently lower than that in HC. We also identified age, CD4 cell counts, time after the last vaccination, and WHO staging type of PLWH as independent factors associated with the seropositivity of antibodies. PLWH receiving booster shot of inactivated vaccines generate higher antibody responses than the second dose, but lower than that in HCs. Decreased anti‐BA.4/5 responses than that of WT impede the protective effect of the third dose on Omicron prevalence.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T-cell responses

            Ugur Sahin, Alexander Muik, Evelyna Derhovanessian … (2020)
            An effective vaccine is needed to halt the spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Recently, we reported safety, tolerability and antibody response data from an ongoing placebo-controlled, observer-blinded phase I/II coronavirus disease 2019 (COVID-19) vaccine trial with BNT162b1, a lipid nanoparticle-formulated nucleoside-modified mRNA that encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein1. Here we present antibody and T cell responses after vaccination with BNT162b1 from a second, non-randomized open-label phase I/II trial in healthy adults, 18-55 years of age. Two doses of 1-50 μg of BNT162b1 elicited robust CD4+ and CD8+ T cell responses and strong antibody responses, with RBD-binding IgG concentrations clearly above those seen in serum from a cohort of individuals who had recovered from COVID-19. Geometric mean titres of SARS-CoV-2 serum-neutralizing antibodies on day 43 were 0.7-fold (1-μg dose) to 3.5-fold (50-μg dose) those of the recovered individuals. Immune sera broadly neutralized pseudoviruses with diverse SARS-CoV-2 spike variants. Most participants had T helper type 1 (TH1)-skewed T cell immune responses with RBD-specific CD8+ and CD4+ T cell expansion. Interferon-γ was produced by a large fraction of RBD-specific CD8+ and CD4+ T cells. The robust RBD-specific antibody, T cell and favourable cytokine responses induced by the BNT162b1 mRNA vaccine suggest that it has the potential to protect against COVID-19 through multiple beneficial mechanisms.
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              Waning Immune Humoral Response to BNT162b2 Covid-19 Vaccine over 6 Months

              Einav Levin, Yaniv Lustig, Carmit Cohen … (2021)
              Background Despite high vaccine coverage and effectiveness, the incidence of symptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been increasing in Israel. Whether the increasing incidence of infection is due to waning immunity after the receipt of two doses of the BNT162b2 vaccine is unclear. Methods We conducted a 6-month longitudinal prospective study involving vaccinated health care workers who were tested monthly for the presence of anti-spike IgG and neutralizing antibodies. Linear mixed models were used to assess the dynamics of antibody levels and to determine predictors of antibody levels at 6 months. Results The study included 4868 participants, with 3808 being included in the linear mixed-model analyses. The level of IgG antibodies decreased at a consistent rate, whereas the neutralizing antibody level decreased rapidly for the first 3 months with a relatively slow decrease thereafter. Although IgG antibody levels were highly correlated with neutralizing antibody titers (Spearman’s rank correlation between 0.68 and 0.75), the regression relationship between the IgG and neutralizing antibody levels depended on the time since receipt of the second vaccine dose. Six months after receipt of the second dose, neutralizing antibody titers were substantially lower among men than among women (ratio of means, 0.64; 95% confidence interval [CI], 0.55 to 0.75), lower among persons 65 years of age or older than among those 18 to less than 45 years of age (ratio of means, 0.58; 95% CI, 0.48 to 0.70), and lower among participants with immunosuppression than among those without immunosuppression (ratio of means, 0.30; 95% CI, 0.20 to 0.46). Conclusions Six months after receipt of the second dose of the BNT162b2 vaccine, humoral response was substantially decreased, especially among men, among persons 65 years of age or older, and among persons with immunosuppression.
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                Author and article information

                Contributors
                Erhei Dai: daieh2008@126.com
                Yongzhe Li: yongzhelipumch@126.com
                Journal
                Journal ID (nlm-ta): J Med Virol
                Journal ID (iso-abbrev): J Med Virol
                Journal ID (doi): 10.1002/(ISSN)1096-9071
                Journal ID (publisher-id): JMV
                Title: Journal of Medical Virology
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 0146-6615
                ISSN (Electronic): 1096-9071
                Publication date (Electronic): 03 January 2023
                Publication date (Print): January 2023
                Publication date PMC-release: 03 January 2023
                Volume: 95
                Issue: 1 ( doiID: 10.1002/jmv.v95.1 )
                Electronic Location Identifier: e28428
                Affiliations
                [ 1 ] Department of Clinical Laboratory, State key Laboratory of Complex, Severe and Rare Diseases, Peking Union Medical College Hospital Chinese Academy of Medical Science and Peking Union Medical College Beijing China
                [ 2 ] Department of Laboratory Medicine, The Fifth Hospital of Shijiazhuang North China University of Science and Technology Tangshan China
                [ 3 ] School of Public Health North China University of Science and Technology Tangshan China
                [ 4 ] Department of Medical Research Center, Peking Union Medical College Hospital Chinese Academy of Medical Science and Peking Union Medical College Beijing China
                [ 5 ] Department of AIDS, The Fifth Hospital of Shijiazhuang North China University of Science and Technology Tangshan China
                Author notes
                [*] [* ] Correspondence Yongzhe Li, Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, 1 Shuaifuyuan, Dongcheng District, Beijing 100730, China.

                Email: yongzhelipumch@ 123456126.com

                Erhei Dai, Department of Laboratory Medicine, The Fifth Hospital of Shijiazhuang, North China University of Science and Technology, No.42 Ta'nan Rd, Yuhua District, Shijiazhuang, Heibei 050021, China.

                Email: daieh2008@ 123456126.com

                Author information
                http://orcid.org/0000-0001-5934-9141
                Article
                Publisher ID: JMV28428
                DOI: 10.1002/jmv.28428
                PMC ID: 9880704
                PubMed ID: 36571267
                SO-VID: e4ecbab5-6ca5-4472-9f5f-84bf15a45689
                Copyright © © 2022 Wiley Periodicals LLC.
                License:

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                Date revision received : 12 December 2022
                Date received : 14 November 2022
                Date accepted : 21 December 2022
                Page count
                Figures: 6, Tables: 2, Pages: 14, Words: 7831
                Funding
                Funded by: National Key Research and Development Program of China (2018YFE0207300)
                Funded by: Beijing Municipal Science & Technology Commission (Z211100002521021)
                Funded by: Key R&D project of Hebei Province (22377744D)
                Categories
                Subject: Research Article
                Subject: Research Articles
                Custom metadata
                source-schema-version-number 2.0
                cover-date January 2023
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.4 mode:remove_FC converted:27.01.2023

                ScienceOpen disciplines: Microbiology & Virology
                Keywords: antibodies,immune response,people with hiv,sars‐cov‐2,vaccination
                Data availability:
                ScienceOpen disciplines: Microbiology & Virology
                Keywords: antibodies, immune response, people with hiv, sars‐cov‐2, vaccination

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