Challenges of conducting an international observational study to assess immunogenicity of multiple COVID-19 vaccines.

ABSTRACT: The International Study on COVID-19 Vaccines to Assess Immunogenicity, Reactogenicity, and Efficacy is an observational study to assess the immunogenicity of COVID-19 vaccines used in Democratic Republic of Congo, Guinea, Indonesia, Liberia, Mali, Mexico, and Mongolia. The study, which has enrolled 5,401 adults, is prospectively following participants for approximately two years. This study is important as it has enrolled participants from resource-limited settings that have largely been excluded from COVID-19 research studies during the pandemic. There are significant challenges to mounting a study during an international health emergency, especially in resource-limited settings. Here we focus on challenges and hurdles encountered during the planning and implementation of the study with r

SUBMITTER: Sardana R 

PROVIDER: S-EPMC10281570 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature