Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials
| Autor: | Ya-Fei Liu, Jing-Liang Wu, Xiao-Yu Xu, Gui-Fan Li, Hongxing Pan, Wenling Wang, Jingxin Li, Jian-Kai Liu, Meng Wang, Baoying Huang, Kai Chu, Li Zhang, Wenjie Tan, Fengcai Zhu, Xian-Yun Chang, Dan-Dan Zhu, Wei-Jin Huang, Jialei Hu |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty COVID-19 Vaccines Phases of clinical research Placebo law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans Seroconversion Adverse effect Inactivated vaccine business.industry SARS-CoV-2 COVID-19 General Medicine Original Articles Neutralizing antibody Immunogenicity Clinical trial Regimen Vaccines Inactivated 030220 oncology & carcinogenesis Medicine Safety business 030217 neurology & neurosurgery |
| Zdroj: | Chinese Medical Journal, Vol 134, Iss 11, Pp 1289-1298 (2021) Chinese Medical Journal |
| ISSN: | 2542-5641 0366-6999 |
| DOI: | 10.1097/CM9.0000000000001573 |
| Popis: | BACKGROUND: The significant morbidity and mortality resulted from the infection of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) call for urgent development of effective and safe vaccines. We report the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, KCONVAC, in healthy adults. METHODS: Phase 1 and phase 2 randomized, double-blind, and placebo-controlled trials of KCONVAC were conducted in healthy Chinese adults aged 18 to 59 years. The participants in the phase 1 trial were randomized to receive two doses, one each on Days 0 and 14, of either KCONVAC (5 or 10 µg/dose) or placebo. The participants in the phase 2 trial were randomized to receive either KCONVAC (at 5 or 10 µg/dose) or placebo on Days 0 and 14 (0/14 regimen) or Days 0 and 28 (0/28 regimen). In the phase 1 trial, the primary safety endpoint was the proportion of participants experiencing adverse reactions/events within 28 days following the administration of each dose. In the phase 2 trial, the primary immunogenicity endpoints were neutralization antibody seroconversion and titer and anti-receptor-binding domain immunoglobulin G seroconversion at 28 days after the second dose. RESULTS: In the phase 1 trial, 60 participants were enrolled and received at least one dose of 5-µg vaccine (nâ=â24), 10-µg vaccine (nâ=â24), or placebo (nâ=â12). In the phase 2 trial, 500 participants were enrolled and received at least one dose of 5-µg vaccine (nâ=â100 for 0/14 or 0/28 regimens), 10-µg vaccine (nâ=â100 for each regimen), or placebo (nâ=â50 for each regimen). In the phase 1 trial, 13 (54%), 11 (46%), and seven (7/12) participants reported at least one adverse event (AE) after receiving 5-, 10-µg vaccine, or placebo, respectively. In the phase 2 trial, 16 (16%), 19 (19%), and nine (18%) 0/14-regimen participants reported at least one AE after receiving 5-, 10-µg vaccine, or placebo, respectively. Similar AE incidences were observed in the three 0/28-regimen treatment groups. No AEs with an intensity of grade 3+ were reported, expect for one vaccine-unrelated serious AE (foot fracture) reported in the phase 1 trial. KCONVAC induced significant antibody responses; 0/28 regimen showed a higher immune responses than that did 0/14 regimen after receiving two vaccine doses. CONCLUSIONS: Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-µg vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial. TRIAL REGISTRATION: http://www.chictr.org.cn/index.aspx (No. ChiCTR2000038804, http://www.chictr.org.cn/showproj.aspx?proj=62350; No. ChiCTR2000039462, http://www.chictr.org.cn/showproj.aspx?proj=63353). |
| Databáze: | OpenAIRE |
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