학술논문

Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.
Document Type
article
Source
Vaccine. 41(33)
Subject
COVID-19 Prevention Network CoVPN
Humans
Adult
COVID-19
COVID-19 Vaccines
2019-nCoV Vaccine mRNA-1273
Ad26COVS1
ChAdOx1 nCoV-19
Comorbidity
Effect modifier
Environmental exposure
Epidemiologic
Occupational exposure
SARS-CoV-2
Vaccine efficacy
Clinical Research
Prevention
Clinical Trials and Supportive Activities
Infectious Diseases
Vaccine Related
Immunization
Evaluation of treatments and therapeutic interventions
6.1 Pharmaceuticals
Prevention of disease and conditions
and promotion of well-being
3.4 Vaccines
Infection
Good Health and Well Being
Biological Sciences
Agricultural and Veterinary Sciences
Medical and Health Sciences
Virology
Language
Abstract
Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802.