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Clinical Trial
. 2022 Aug;39(8):3789-3798.
doi: 10.1007/s12325-022-02206-1. Epub 2022 Jun 30.

Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 Trial

Jingxin Li #  1 , Ai-Min Hui #  2 , Xiang Zhang  3 , Lei Ge  4 , Yuanzheng Qiu  4 , Rong Tang  1 , Huayue Ye  5   6 , Xiyuan Wang  4 , Mei Lin  7 , Zhongkui Zhu  3 , Jianfei Zheng  4 , Jingjun Qiu  4 , Eleni Lagkadinou  8 , Svetlana Shpyro  8 , Orkun Ozhelvaci  8 , Özlem Türeci  8 , Zakaria Khondker  9 , Wanrong Yin  9 , Yoana Shishkova  8 , Siyue Jia  1 , Hongxing Pan  1 , Fuzhong Peng  5 , Zhilong Ma  3 , Zhenggang Wu  7 , Xiling Guo  1 , Yunfeng Shi  1 , Alexander Muik  8 , Uğur Şahin  8 , Li Zhu  10 , Fengcai Zhu  11   12
Affiliations
Clinical Trial

Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 Trial

Jingxin Li et al. Adv Ther. 2022 Aug.

Abstract

Introduction: BNT162b1 is a lipid nanoparticle-formulated, nucleoside-modified mRNA SARS-CoV-2 vaccine. Here, we report safety and immune persistence data following a primary two-dose vaccination schedule administered 21 days apart.

Methods: Immune persistence was determined at month 3 in 72 younger participants (aged 18-55 years) and at month 6 in 70 younger and 69 older participants (aged 65-85 years).

Results: In younger participants, neutralizing antibody (nAb) geometric mean titers (GMTs) for the 10 and 30 µg dose levels declined from 233 and 254 (21 days after dose 2) to 55 and 87 at month 3, respectively, and to 16 and 27 at month 6, respectively. In older participants, nAb GMTs declined from 80 and 160 (21 days after dose 2) to 10 and 21 at month 6. Overall, higher antibody titers were observed in younger participants, and the 30 µg dose induced higher levels of nAb, which declined more slowly by month 6. No serious adverse events were reported in the vaccine group.

Conclusion: This study showed BNT162b1 maintains a favorable safety profile in younger and older participants in the 6 months after vaccination. This study further extends our understanding of immune persistence and the safety of the BNT162b1 vaccine as a candidate vaccine in the BioNTech pipeline.

Trial registration number: NCT04523571, registered August 21, 2020.

Keywords: COVID; Immune persistence; SARS-CoV-2; mRNA vaccine.

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Figures

Fig. 1
Fig. 1
Longitudinal geometric mean titer of virus-neutralizing antibody, anti-S1 IgG and anti-RBD IgG in healthy participants over 6 months. A GMT of neutralizing SARS-CoV-2 antibodies. B GMT of anti-S1 antibodies. C GMT of anti-RBD antibodies. Participants received two doses of BNT162b1 (10 or 30 µg) or placebo (saline) on days 1 and 22. Blood samples were not collected from older participants (aged 65–85 years) at day 8 and 3 months after dose 1. The error bar was standard error. anti-RBD IgG antibody to receptor binding domain, anti-S1 IgG antibody to S1 protein, GMT geometric mean titer, SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
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