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. 2022 Dec;11(1):639-647.
doi: 10.1080/22221751.2022.2025746.

Safety and immunogenicity of a third-dose homologous BBIBP-CorV boosting vaccination: interim results from a prospective open-label study

Affiliations

Safety and immunogenicity of a third-dose homologous BBIBP-CorV boosting vaccination: interim results from a prospective open-label study

Jingwen Ai et al. Emerg Microbes Infect. 2022 Dec.

Abstract

A COVID-19 booster vaccination is being comprehensively evaluated globally due to the emerging concern of reduced protection rate of previous vaccination and circulating Variants of Concern (VOC). But the safety and immunogenicity of homologous BBIBP-CorV boosting vaccination are yet to be thoroughly evaluated. We conducted this prospective, open-label study in Huashan Hospital using a third 6.5U BBIBP-CorV administered at an interval of 4-8 months following the previous two doses in healthy adults. Safety, anti-RBD response and neutralizing titers against SARS-CoV-2 and VOCs were examined. Sixty-three and forty participants entered the booster and the control group, respectively. A significant increase in IFN-γ SFU per million PBMCs was observed on day 14 against N peptide (20 vs. 5, P < 0.001). On day 14, pVNT GMTs increased over 15 folds of the baseline levels against prototype to reach 404.54 titers and over 9-13 folds against 4 VOCs and continuously increased by day 28. sVNT GMTs increased 112.51 and 127.45 folds by days 14 and 28 compared to the baseline level. Median anti-RBD antibody and IgG level significantly increased from 11.12 to 2607.50 BAU/ml and 4.07 to 619.20 BAU/ml on day 14. On day 14, females showed a significantly higher cell-mediated immune response against S1 peptide. The 7-8 months interval group had a higher humoral response than the 4-6 months interval group. No severe adverse event was reported. A third homologous BBIBP-CorV boosting vaccination was safe and highly immunogenic for healthy adults and broadened participants' immunity against VOCs.

Keywords: SARS-CoV-2 inactivated vaccines; booster vaccination shot; homologous; immunogenicity; safety.

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Conflict of interest statement

No potential conflict of interest was reported by the authors.

Figures

Figure 1.
Figure 1.
The flowchart of the study.
Figure 2.
Figure 2.
Immune response after the third-dose vaccination. (a) IFN-γ SFU/million PBMCs after the third-dose vaccination. (b) Humoral immune responses against prototype and variants of SARS-CoV-2 after the third-dose vaccination evaluated by pVNT. (c) Humoral immune responses after the third-dose vaccination evaluated by sVNT. (d) Humoral immune responses after the third-dose vaccination evaluated by an anti-RBD antibody. (e) Humoral immune responses after the third-dose vaccination evaluated by anti-RBD IgG.
Figure 3.
Figure 3.
Impact of the interval among three doses of BBIBP-CorV vaccinations on humoral immune responses and T-cell response. (a) pVNT titer against prototype and variants of SARS-CoV-2 in participants administered with third doses at 4–6 months and 7–8 months intervals after second doses; (b) T-cell response in participants administered with third doses at 4–6 months and 7–8 months intervals after second doses.

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