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Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial.

ABSTRACT: NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, are randomized 1:1 to receive either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The incidence of adverse reactions is low, and the overall safety profile is quite similar between two booster regimens. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster are significantly higher than those by BBIBP-CorV booster against not only SARS-CoV-2 prototype strain but also multiple variants of concerns (VOCs). Especially, the neutralizing antibody GMT against Omicron variant induced by heterologous NVSI-06-08 booster reaches 367.67, which is substantially greater than that boosted by BBIBP-CorV (GMT: 45.03). In summary, NVSI-06-08 is safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which is immunogenically superior to the homologous boost with another dose of BBIBP-CorV.

SUBMITTER: Kaabi NA

PROVIDER: S-EPMC9237056 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial.

Kaabi Nawal Al NA Yang Yun Kai YK Du Li Fang LF Xu Ke K Shao Shuai S Liang Yu Y Kang Yun Y Su Ji Guo JG Zhang Jing J Yang Tian T Hussein Salah S ElDein Mohamed Saif MS Yang Sen Sen SS Lei Wenwen W Gao Xue Jun XJ Jiang Zhiwei Z Cong Xiangfeng X Tan Yao Y Wang Hui H Li Meng M Mekki Hanadi Mekki HM Zaher Walid W Mahmoud Sally S Zhang Xue X Qu Chang C Liu Dan Ying DY Zhang Jing J Yang Mengjie M Eltantawy Islam I Hou Jun Wei JW Lei Ze Hua ZH Xiao Peng P Wang Zhao Nian ZN Yin Jin Liang JL Mao Xiao Yan XY Zhang Jin J Qu Liang L Zhang Yun Tao YT Yang Xiao Ming XM Wu Guizhen G Li Qi Ming QM

Nature communications 20220627 1

NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of ...[more]

PMID: 35760812

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Project description:BackgroundThe immunity induced by primary vaccination is effective against COVID-19; however, booster vaccines are needed to maintain vaccine-induced immunity and improve protection against emerging variants. Heterologous boosting is believed to result in more robust immune responses. This study investigated the safety and immunogenicity of the Razi Cov Pars vaccine (RCP) as a heterologous booster dose in people primed with Beijing Bio-Institute of Biological Products Coronavirus Vaccine (BBIBP-CorV).MethodsWe conducted a randomized, double-blind, active-controlled trial in adults aged 18 and over primarily vaccinated with BBIBP-CorV, an inactivated SARS-CoV-2 vaccine. Eligible participants were randomly assigned (1:1) to receive a booster dose of RCP or BBIBP-CorV vaccines. The primary outcome was neutralizing antibody activity measured by a conventional virus neutralization test (cVNT). The secondary efficacy outcomes included specific IgG antibodies against SARS-CoV-2 spike (S1 and receptor-binding domain, RBD) antigens and cell-mediated immunity. We measured humoral antibody responses at 2 weeks (in all participants) and 3 and 6 months (a subgroup of 101 participants) after the booster dose injection. The secondary safety outcomes were solicited and unsolicited immediate, local, and systemic adverse reactions.ResultsWe recruited 483 eligible participants between December 7, 2021, and January 13, 2022. The mean age was 51.9 years, and 68.1% were men. Neutralizing antibody titers increased about 3 (geometric mean fold increase, GMFI = 2.77, 95% CI 2.26-3.39) and 21 (GMFI = 21.51, 95% CI 16.35-28.32) times compared to the baseline in the BBIBP-CorV and the RCP vaccine groups. Geometric mean ratios (GMR) and 95% CI for serum neutralizing antibody titers for RCP compared with BBIBP-CorV on days 14, 90, and 180 were 6.81 (5.32-8.72), 1.77 (1.15-2.72), and 2.37 (1.62-3.47) respectively. We observed a similar pattern for specific antibody responses against S1 and RBD. We detected a rise in gamma interferon (IFN-γ), tumor necrosis factor (TNF-α), and interleukin 2 (IL-2) following stimulation with S antigen, particularly in the RCP group, and the flow cytometry examination showed an increase in the percentage of CD3 + /CD8 + lymphocytes. RCP and BBIBP-CorV had similar safety profiles; we identified no vaccine-related or unrelated deaths.ConclusionsBBIBP-CorV and RCP vaccines as booster doses are safe and provide a strong immune response that is more robust when the RCP vaccine is used. Heterologous vaccines are preferred as booster doses.Trial registrationThis study was registered with the Iranian Registry of Clinical Trial at www.irct.ir , IRCT20201214049709N4. Registered 29 November 2021.

Project description:BackgroundBooster 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.MethodsWe 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.Results305 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.ConclusionHeterologous 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.

Project description:AimsSevere acute respiratory syndrome coronavirus type 2 (SARS-COV-2) infection may increase the risk of developing dangerous symptoms among the elderly with underlying medical conditions. The aim of this study was to evaluate the safety and immunogenicity of the SARS-CoV-2 inactivated vaccine (Vero) in patients over 60 years of age with hypertension and/or diabetes.MethodsAn open-label, multi-center, prospective clinical trial was conducted at three medical sites in Fujian, China. Participants aged 60 years and above with hypertension, diabetes, and healthy controls were included in four groups: hypertension, diabetes, combined disease, and healthy controls. Volunteers received two doses of the inactivated SARS-COV-2 vaccine (BBIBP-CorV) on days 0 and 21. Adverse events were recorded for 21 days after each dose. Blood samples were taken before the first vaccination and 28 days after the second vaccination to detect the serum conversion rate and geometric mean titer (GMT) of neutralizing antibodies.ResultsA total of 480 participants (110 hypertension, 110 diabetes, 100 combined hypertension and diabetes, and 160 healthy controls) were recruited. The incidences of adverse events in the four groups were 10 (9.1%) in the hypertension group, 19 (17.3%) in the diabetes group, 11 (11.0%) in the combined disease group, and 11 (6.9%) in healthy controls, with no statistical significance (P > 0.05). At 28 days after the second vaccination, the positive conversion rates of serum neutralizing antibody in the four groups were 97.3%(107/110), 97.3% (107/110), 100.0% (99/99),and 98.7%(155/157), respectively, and the GMTs were 75.28 (95% CI 64.03-88.50), 69.4 (95% CI 59-81.63), 77.21 (95% CI 66.68-89.41), and 78.64 (95% CI 69.87-88.50), respectively. There was no significant difference in neutralizing antibody responses among the four groups (P > 0.05). Additionally, the GMT after immunization was higher in females than in males (OR = 2.59, 95% CI 1.31-5.12).ConclusionsThe BBIBP-CorV vaccine is safe and elicits an adequate antibody response in patients over 60 years of age with hypertension and/or diabetes.Trial registrationClinicalTrials.gov identifier, NCT05065879.

Dataset Information

Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial.

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Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial.

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