Safety and efficacy of COVID-19 prime-boost vaccinations: Homologous BBIBP-CorV versus heterologous BNT162b2 boosters in BBIBP-CorV-primed individuals.

Autor: Mallah SI; Royal College of Surgeons in Ireland - Bahrain, Bahrain., Alawadhi A; Bahrain Defence Force Hospital, Bahrain; National Taskforce for Combating the Coronavirus (COVID-19), Bahrain., Jawad J; National Taskforce for Combating the Coronavirus (COVID-19), Bahrain; Supreme Council of Health, Bahrain., Wasif P; Royal College of Surgeons in Ireland - Bahrain, Bahrain., Alsaffar B; Ministry of Health, Bahrain., Alalawi E; Ministry of Health, Bahrain., Mohamed AM; Ministry of Health, Bahrain., Butler AE; Royal College of Surgeons in Ireland - Bahrain, Bahrain., Alalawi B; Ministry of Health, Bahrain., Qayed D; Bahrain Defence Force Hospital, Bahrain., Almahari SA; Ministry of Health, Bahrain., Mubarak A; Ministry of Health, Bahrain., Mubarak A; Ministry of Health, Bahrain., Saeed S; Royal College of Surgeons in Ireland - Bahrain, Bahrain., Humaidan A; National Taskforce for Combating the Coronavirus (COVID-19), Bahrain., Kumar N; Royal College of Surgeons in Ireland - Bahrain, Bahrain., Atkin S; Royal College of Surgeons in Ireland - Bahrain, Bahrain., Alqahtani M; Royal College of Surgeons in Ireland - Bahrain, Bahrain; Bahrain Defence Force Hospital, Bahrain; National Taskforce for Combating the Coronavirus (COVID-19), Bahrain. Electronic address: mqahtani@rcsi-mub.com.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2023 Mar 17; Vol. 41 (12), pp. 1925-1933. Date of Electronic Publication: 2023 Jan 23.
DOI: 10.1016/j.vaccine.2023.01.032
Abstrakt: Background: Booster vaccine doses against SARS-CoV-2 have been advocated to address evidence of waning immunity, breakthrough infection, and the emergence of immune-evasive variants. A heterologous prime-boost vaccine strategy may offer advantages over a homologous approach, but the safety and efficacy of this approach with the mRNA vaccine BNT162b2 (BNT: Pfizer) and inactivated BBIBP-CorV (BBIBT: Sinopharm) vaccines have not been studied.
Methods: We conducted a non-randomized, non-blinded phase II observational community trial acrossBahrain, investigating the reactogenic and immunogenic responseof participants who had previously received two doses of BBIBP, followed by a third booster dose of either BBIBP (homologous booster) or BNT (heterologous booster). Immunogenicity through serological statuswas determined at baseline and on the following 8thweek. Reactogenicity data (safety and adverse events) were collected throughout study period, in addition to participant-led electronic journaling.
Results: 305 participants (152 BBIBP and 153 BNT booster) were enrolled in the study,with 246 (127 BBIBP and 119 BNT booster) included in the final analysis. There was a significant increase in anti-SARS-CoV-2 antibody levels post booster administration in both groups; however, the heterologous BNT arm demonstrated a significantly larger mean increase in the level of spike (S) antigen-specific antibodies (32.7-fold increase versus 2.6, p < 0.0001) and sVNT neutralising antibodies (3.4-fold increase versus 1.8, p < 0.0001), whereas the homologous arm demonstrated a significant increase in the levels of nucleocapsid (N) antigen-specific antibodies (3.8-fold increase versus none). Non-serious adverse events (injection site pain, fever, and fatigue) were more commonly reported in the heterologous arm, but no serious adverse events occurred.
Conclusion: Heterologous prime-boost vaccination with the mRNA BNT162b2 (Pfizer) vaccine in those who had received two doses of inactivated virus BBIBP-CorV (Sinopharm) vaccine demonstrated a more robust immune response against SARS-CoV-2 than the homologous BBIBP booster and appears safe and well tolerated. Clinical Trial Registry Number (ClinicalTrials.gov): NCT04993560.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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