Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls
Year: 2017
Type: review
Abstract: Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under 'real world' conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls. Rigorous planning and preparation should focus on understanding the study context including healthcare-seeking and vaccination practices. Case-control vaccine effectiveness studies are best carried out soon after vaccine introduction because high coverage creates strong potential for confounding. Endpoints specific to the vaccine target are preferable to non-specific clinical syndromes since the proportion of non-specific outcomes preventable through vaccination may vary over time and place, leading to potentially confusing results. Controls should be representative of the source population from which cases arise, and are generally recruited from the community or health facilities where cases are enrolled. Matching of controls to cases for potential confounding factors is commonly used, although should be reserved for a limited number of key variables believed to be linked to both vaccination and disease. Case-control vaccine effectiveness studies can provide information useful to guide policy decisions and vaccine development, however rigorous preparation and design is essential.
Source: Vaccine
Authors: Jennifer R. Verani, Abdullah H. Baqui, Claire V. Broome, Thomas Cherian, Cheryl Cohen, Jennifer L. Farrar, Daniel R. Feikin, Michelle J. Groome, Rana A. Hajjeh, Hope L. Johnson, Shabir A. Madhi, Kim Mulholland, Katherine L. O'Brien, Umesh D. Parashar, Manish M. Patel, Laura C. Rodrigues, Mathuram Santosham, J. Anthony Scott, Peter G. Smith, Halvor Sommerfelt, Jacqueline E. Tate, J. Chris Victor, Cynthia G. Whitney, Anita K. Zaidi, Elizabeth R. Zell
Institutions: Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Johns Hopkins University, Emory University, World Health Organization, National Institute for Communicable Diseases, University of the Witwatersrand, Gavi, Royal Children's Hospital, London School of Hygiene & Tropical Medicine, Murdoch Children's Research Institute, Kenya Medical Research Institute, KEMRI-Wellcome Trust Research Programme, Norwegian Institute of Public Health, University of Bergen, Aga Khan University, Program for Appropriate Technology in Health
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: hybrid
Estimated APC paid: $3,620
Awards: Population impact of conjugate vaccine on pneumococcal transmission and disease in Kenya., G7888718989, Core Support for the East African Major Overseas Programme, RESEARCH ON THE EPIDEMIOLOGY,PREVENTION,VACCINE EFFECTIVENESS AND TREATMENT OF INFLUENZA AND OTHER RESPIRATORY VIRUSES IN SOUTH AFRICA.09
OpenAlex ID: W2605758023