Immunogenicity and Safety of a 3-Dose Regimen of a SARS-CoV-2 Inactivated Vaccine in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
| Autor: | Jiankai, Liu, Baoying, Huang, Guifan, Li, Xianyun, Chang, Yafei, Liu, Kai, Chu, Jialei, Hu, Yao, Deng, Dandan, Zhu, Jingliang, Wu, Li, Zhang, Meng, Wang, Weijin, Huang, Hongxing, Pan, Wenjie, Tan |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
safety COVID-19 Vaccines Adolescent SARS-CoV-2 three-dose regimen COVID-19 Middle Aged immunogenicity Antibodies Viral Antibodies Neutralizing Young Adult Immunogenicity Vaccine AcademicSubjects/MED00290 Infectious Diseases Double-Blind Method Vaccines Inactivated Immunoglobulin G Major Article Humans Immunology and Allergy SARS-CoV-2 inactivated vaccine |
| Zdroj: | The Journal of Infectious Diseases |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/jiab627 |
| Popis: | Background Control of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic needs effective vaccines. Methods In a phase 2 randomized, double-blind, placebo-controlled trial, 500 adults aged 18–59 years or ≥60 years were randomized in 2:2:1 ratio to receive 3 doses of 5 μg or 10 μg of a SARS-CoV-2 inactivated vaccine, or placebo separated by 28 days. Adverse events (AEs) were recorded through day 28 after each dosing. Live virus or pseudovirus neutralizing antibodies, and receptor binding domain immunoglobulin G (RBD-IgG) antibody were tested after the second and third doses. Results Two doses of the vaccine elicited geometric mean titers (GMTs) of 102–119, 170–176, and 1449–1617 for the 3 antibodies in younger adults. Pseudovirus neutralizing and RBD-IgG GMTs were similar between older and younger adults. The third dose slightly ( Conclusions Two doses of this vaccine induced robust immune response and had good safety profile. A third dose given 28 days after the second dose elicited limited boosting antibody response. |
| Databáze: | OpenAIRE |
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