Dataset Information

Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2.

ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) threatens global public health. The development of a vaccine is urgently needed for the prevention and control of COVID-19. Here, we report the pilot-scale production of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) that induces high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits, and nonhuman primates (cynomolgus monkeys and rhesus macaques) to provide protection against SARS-CoV-2. Two-dose immunizations using 2 ?g/dose of BBIBP-CorV provided highly efficient protection against SARS-CoV-2 intratracheal challenge in rhesus macaques, without detectable antibody-dependent enhancement of infection. In addition, BBIBP-CorV exhibits efficient productivity and good genetic stability for vaccine manufacture. These results support the further evaluation of BBIBP-CorV in a clinical trial.

SUBMITTER: Wang H

PROVIDER: S-EPMC7275151 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2.

Wang Hui H Zhang Yuntao Y Huang Baoying B Deng Wei W Quan Yaru Y Wang Wenling W Xu Wenbo W Zhao Yuxiu Y Li Na N Zhang Jin J Liang Hongyang H Bao Linlin L Xu Yanfeng Y Ding Ling L Zhou Weimin W Gao Hong H Liu Jiangning J Niu Peihua P Zhao Li L Zhen Wei W Fu Hui H Yu Shouzhi S Zhang Zhengli Z Xu Guangxue G Li Changgui C Lou Zhiyong Z Xu Miao M Qin Chuan C Wu Guizhen G Gao George Fu GF Tan Wenjie W Yang Xiaoming X

Cell 20200606 3

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) threatens global public health. The development of a vaccine is urgently needed for the prevention and control of COVID-19. Here, we report the pilot-scale production of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) that induces high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits, and nonhuman primates (cynomolgus monkeys and rhesus maca ...[more]

PMID: 32778225

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Project description:Several observational studies have confirmed that the severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) might substantially affect the gastrointestinal (GI) system by replicating in human small intestine enterocytes. Yet, so far, no study has reported the effects of inactivated SARS-CoV-2 virus vaccines on gut microbiota alterations. In this study, we examined the effects of the BBIBP-CorV vaccine (ChiCTR2000032459, sponsored by the Beijing Institute of Biological Products/Sinopharm), on gut microbiota. Fecal samples were collected from individuals whoreceived two doses of intramuscular injection of BBIBP-CorV and matched unvaccinated controls. DNA extracted from fecal samples was subjected to 16S ribosomal RNA sequencing analysis. The composition and biological functions of the microbiota between vaccinated and unvaccinated individuals were compared. Compared with unvaccinated controls, vaccinated subjects exhibited significantly reduced bacterial diversity, elevated firmicutes/bacteroidetes (F/B) ratios, a tendency towards Faecalibacterium-predominant enterotypes, and altered gut microbial compositions and functional potentials. Specifically, the intestinal microbiota in vaccine recipients was enriched with Faecalibacterium and Mollicutes and with a lower abundance of Prevotella, Enterococcus, Leuconostocaceae, and Weissella. Microbial function prediction by phylogenetic investigation of communities using reconstruction of unobserved states (PICRUSt) analysis further indicated that Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways involved in carbohydrate metabolism and transcription were positively associated with vaccine inoculation, whereas capacities in neurodegenerative diseases, cardiovascular diseases, and cancers were negatively affected by vaccines. Vaccine inoculation was particularly associated with gut microbiota alterations, as was demonstrated by the improved composition and functional capacities of gut microbiota.

Project description:ObjectiveTo estimate the prevalence of post-vaccination seropositivity against SARS-CoV-2 and identify its predictors in Peruvian Social Health Insurance (EsSalud) personnel in 2021.MethodsWe conducted a cross-sectional study in a representative simple stratified sample of EsSalud workers. We evaluated IgG anti-SARS-CoV-2 antibodies response (seropositivity) by passive (previous infection) and active immunization (vaccination), and epidemiological and occupational variables obtained by direct interview and a data collection form. Descriptive and inferential statistics were used with correction of sample weights adjusted for non-response rate, and crude and adjusted odds ratio (OR) and geometric mean ratio (GMR) with their respective 95% confidence intervals (95%CI) were estimated.ResultsWe enrolled 1077 subjects. Seropositivity was 67.4% (95%CI: 63.4-71.1). Predictors of seropositivity were age (negative relation; p < 0.001), previous infection (aOR = 11.7; 95%CI: 7.81-17.5), working in COVID-19 area (aOR = 1.47; 95%CI: 1.02-2.11) and time since the second dose. In relation to antibody levels measured by geometric means, there was an association between male sex (aGMR = 0.77; 95%CI: 0.74-0.80), age (negative relation; p < 0.001), previous infection (aGMR = 13.1; 95%CI:4.99-34.40), non-face-to-face/licensed work modality (aGMR = 0.78; 95%CI: 0.73-0.84), being a nursing technician (aGMR = 1.30; 95%CI: 1.20-1.41), working in administrative areas (aGMR = 1.17; 95%CI: 1.10-1.25), diagnostic support (aGMR = 1.07; 95%CI: 1.01-1.15), critical care (aGMR = 0.85; 95%CI: 0.79-0.93), and in a COVID-19 area (aGMR = 1.30; 95%CI: 1.24-1.36) and time since receiving the second dose (negative relation; p < 0.001).ConclusionsSeropositivity and antibody levels decrease as the time since receiving the second dose increases. Older age and no history of previous infection were associated with lower seropositivity and antibody values. These findings may be useful for sentinel antibody surveillance and the design of booster dose strategies.

Project description:BackgroundWe provide national estimates of the real-world Vaccine effectiveness (VE) based on nationally available surveillance data. The study aimed to estimate the effectiveness of the inactivated Covid-19 vaccine BBIBP-CorV (Vero Cells) Sinopharm vaccine currently deployed in Morocco against SARS- CoV-2 severe disease/ hospitalization" within 9 months after vaccination.MethodsWe conducted a test-negative, case-control study among a population aged 18 years or older who were tested by rt-PCR for SARS-CoV-2 infection from February to October 2021 in Morocco. From the national laboratory COVID-19 database; we identified cases who were rt-PCR positive amongst severe and critical COVID-19 cases and controls who had a negative rt-PCR test for SARS-CoV-2. From the national vaccination register (NVR); individuals vaccinated with COVID-19 Vaccine (Vero Cell) and those unvaccinated were identified and included in the study. The linkage between databases was conducted for the study of Vaccination status based on the timing of the vaccine receipt relative to the SARS-CoV-2 rt-PCR test date. For each person, who tested positive for SARS-CoV-2, we identified a propensity score-matched control participant who was tested negative. We estimated vaccine effectiveness against SARS- CoV-2 severe disease/ hospitalization using conditional logistic regression.ResultsAmong 12884 persons who tested positive and 12885 propensity score-matched control participants, the median age was 62 years, 47.2% of whom were female. As a function of time after vaccination of second dose vaccination, vaccine effectiveness during the first month was 88% (95% CI, 84-91), 87% (95% CI: 83-90) during the second and third month, 75% (95% CI: 67-80) during the fourth month, 61% (95% CI: 54-67) during the fifth month, and 64% (95% CI: 59-69) beyond the sixth month. VE remained high and stable during the first three months in the two-age subgroup. In the fourth month, the VE in the older population aged 60 years and above (64%) was reduced by 20 points compared to VE in the younger population (84%).ConclusionA Sinopharm vaccine is highly protective against serious SARS-CoV-2 infection under real-world conditions. Protection remained high and stable during the first three months following the second dose and decreases slightly beyond the fourth month especially beyond 60 years.

Dataset Information

Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2.

Publications

Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2.

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