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Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults

医学 随机对照试验 不利影响 2019年冠状病毒病(COVID-19) 中期分析 入射(几何) 临时的 内科学 严重急性呼吸综合征冠状病毒2型(SARS-CoV-2) 疾病 历史 光学 物理 考古 传染病(医学专业)
作者
Nawal Al Kaabi,Yuntao Zhang,Shengli Xia,Yunkai Yang,Manaf M. Al Qahtani,Najiba M. Abdulrazzaq,Majed Al Nusair,Mohamed Hassany,Jaleela S. Jawad,Jehad Abdalla,Salah Eldin Hussein,Shamma K. Al Mazrouei,Maysoon Al Karam,Xinguo Li,Xuqin Yang,Wei Wang,Bonan Lai,Wei Chen,Shihe Huang,Qian Wang
出处
期刊:JAMA [American Medical Association]
被引量:772
标识
DOI:10.1001/jama.2021.8565
摘要

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 < .001 for both). Two severe cases of COVID-19 occurred in the alum-only group and none occurred in the vaccine groups. Adverse reactions 7 days after each injection occurred in 41.7% to 46.5% of participants in the 3 groups; serious adverse events were rare and similar in the 3 groups (WIV04: 64 [0.5%]; HB02: 59 [0.4%]; alum-only: 78 [0.6%]).

Conclusions and Relevance

In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19, and serious adverse events were rare. Data collection for final analysis is pending.

Trial Registration

ClinicalTrials.gov Identifier:NCT04510207; Chinese Clinical Trial Registry:ChiCTR2000034780
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