Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial
| Autor: | Wei Wang, Islam Eltantawy, Yuxiu Zhao, Hui Wang, Salah Eldin Hussein, Majed Al Nusair, Shamma K Al Mazrouei, Jaleela S Jawad, Walid Abbas Zaher, Yan-Bo Zhang, Sally Mahmoud, Xinguo Li, Shengli Xia, Wei Chen, Guoqing Zhao, Zhiqiang Xie, Wangyang You, Yuntao Zhang, Xuqin Yang, Tian Yang, Xiaoming Yang, Zaidoon M Hussain, Peng Xiao, Maysoon Al Karam, An Pan, Manaf M Al Qahtani, Najiba Abdulrazzaq, Mohammed Saifuddin Fasihuddin, Rui Ma, Kai Duan, Tehmina Khan, Mohamed Hassany, Shihe Huang, Nawal Al Kaabi, Jehad Abdalla, Yunkai Yang, Qian Wang, Bonan Lai, Ashish Koshy, Liu Yang, Zhiwei Jiang |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization COVID-19 Vaccines Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Datasets as Topic 01 natural sciences Injections Intramuscular law.invention 03 medical and health sciences Middle East 0302 clinical medicine Immunogenicity Vaccine Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans 030212 general & internal medicine 0101 mathematics Adverse effect Original Investigation business.industry Incidence (epidemiology) 010102 general mathematics COVID-19 General Medicine Middle Aged Interim analysis Vaccine efficacy Clinical trial Vaccines Inactivated Female business |
| Zdroj: | JAMA |
| Popis: | IMPORTANCE: Although effective vaccines against COVID-19 have been developed, additional vaccines are still needed. OBJECTIVE: To evaluate the efficacy and adverse events of 2 inactivated COVID-19 vaccines. DESIGN, SETTING, AND PARTICIPANTS: Prespecified interim analysis of an ongoing randomized, double-blind, phase 3 trial in the United Arab Emirates and Bahrain among adults 18 years and older without known history of COVID-19. Study enrollment began on July 16, 2020. Data sets used for the interim analysis of efficacy and adverse events were locked on December 20, 2020, and December 31, 2020, respectively. INTERVENTIONS: Participants were randomized to receive 1 of 2 inactivated vaccines developed from SARS-CoV-2 WIV04 (5 µg/dose; n = 13 459) and HB02 (4 µg/dose; n = 13 465) strains or an aluminum hydroxide (alum)–only control (n = 13 458); they received 2 intramuscular injections 21 days apart. MAIN OUTCOMES AND MEASURES: The primary outcome was efficacy against laboratory-confirmed symptomatic COVID-19 14 days following a second vaccine dose among participants who had no virologic evidence of SARS-CoV-2 infection at randomization. The secondary outcome was efficacy against severe COVID-19. Incidence of adverse events and reactions was collected among participants who received at least 1 dose. RESULTS: Among 40 382 participants randomized to receive at least 1 dose of the 2 vaccines or alum-only control (mean age, 36.1 years; 32 261 [84.4%] men), 38 206 (94.6%) who received 2 doses, contributed at least 1 follow-up measure after day 14 following the second dose, and had negative reverse transcriptase–polymerase chain reaction test results at enrollment were included in the primary efficacy analysis. During a median (range) follow-up duration of 77 (1-121) days, symptomatic COVID-19 was identified in 26 participants in the WIV04 group (12.1 [95% CI, 8.3-17.8] per 1000 person-years), 21 in the HB02 group (9.8 [95% CI, 6.4-15.0] per 1000 person-years), and 95 in the alum-only group (44.7 [95% CI, 36.6-54.6] per 1000 person-years), resulting in a vaccine efficacy, compared with alum-only, of 72.8% (95% CI, 58.1%-82.4%) for WIV04 and 78.1% (95% CI, 64.8%-86.3%) for HB02 (P |
| Databáze: | OpenAIRE |
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