Cited by 102Statistical Methods in EpidemiologyVaccine Coverage and HesitancyBacterial Infections and Vaccines

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Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls

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Verani, Jennifer R., Baqui, Abdullah H., Broome, Claire V., Cherian, Thomas, Cohen, Cheryl, Farrar, Jennifer L., Feikin, Daniel R., Groome, Michelle J., Hajjeh, Rana A., Johnson, Hope L., Madhi, Shabir A., Mulholland, Kim, O'Brien, Katherine L., Parashar, Umesh D., Patel, Manish M., Rodrigues, Laura C., Santosham, Mathuram, Scott, J. Anthony, Smith, Peter G., Sommerfelt, Halvor, Tate, Jacqueline E., Victor, J. Chris, Whitney, Cynthia G., Zaidi, Anita K., Zell, Elizabeth R.·2017·Vaccine

DOI 10.1016/j.vaccine.2017.04.037PMC PMC7007298

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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.

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An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia—Study Protocol
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“Case–control studies, by contrast, compare past exposure with vaccination between individuals who have and have not experienced the adverse event of interest 21 (termed ‘cases’ and ‘controls’, respectively).”
Upper and Lower Endoscopic Findings in Mesenteric Panniculitis Patients: A Case-Control Study
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Kinematic cervical rotation performance in patients with acute non-specific neck pain during the DidRen test improves after manual mobilizations regardless of the painful spinal levelPreprint
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Datta, R. (2021) · Medical Journal Armed Forces India · doi:10.1016/j.mjafi.2021.07.008
“Both types of study calculate the risk of infection and disease among vaccinated and unvaccinated persons, and determine the reduction in risk.(4) While vaccine efficacy is studied in an ideal setting, as a prospective randomized control trial (where effect of vaccination in prevention of infection or disease can be p…”
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Effectiveness of COVID-19 Vaccine in Prevention of Mortality Among Moderate-Severe Cases
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“%) in the 18–59-year CRD subgroup and limited sample size compared to the other age groups [41].”
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“While VE studies might be best done soon after vaccine introduction when coverage is below 80% [14], providing data from real world conditions on vaccine performance can help provide evidence to sustain vaccination programs.”
Quantitative systems pharmacology of HIV PrEP and PEP
Iannuzzi, S., Zhang, L., Liebenberg, A., Kim, H.-Y., & von Kleist, M. (2026) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2026.2715711
“Similar to assessing vaccine efficacy, prophylactic efficacy may also be confirmed in case-control studies [10].”

Authors: Verani, J. R., Baqui, A. H., Broome, C. V., Cherian, T., Cohen, C., Farrar, J. L., Feikin, D. R., Groome, M. J., Hajjeh, R. A., Johnson, H. L., Madhi, S. A., Mulholland, K., O'Brien, K. L., Parashar, U. D., Patel, M. M., Rodrigues, L. C., Santosham, M., Scott, J. A., Smith, P. G., Sommerfelt, H., Tate, J. E., Victor, J. C., Whitney, C. G., Zaidi, A. K., & Zell, E. R.
Affiliations: Centers for Disease Control and Prevention (US)
Johns Hopkins University (US)
Emory University (US)
World Health Organization (CH)
National Institute for Communicable Diseases (ZA)
University of the Witwatersrand (ZA)
Gavi (CH)
Royal Children's Hospital (AU)
London School of Hygiene & Tropical Medicine (GB)
Kenya Medical Research Institute (KE)
Norwegian Institute of Public Health (NO)
Aga Khan University (PK)
Corresponding author: Verani, Jennifer R.
ORCID: Verani, Jennifer R.
Baqui, Abdullah H.
Cherian, Thomas
Cohen, Cheryl
Farrar, Jennifer L.
Feikin, Daniel R.
Groome, Michelle J.
Hajjeh, Rana A.
Johnson, Hope L.
Madhi, Shabir A.
Mulholland, Kim
Parashar, Umesh D.
Patel, Manish M.
Rodrigues, Laura C.
Scott, J. Anthony
Smith, Peter G.
Sommerfelt, Halvor
Tate, Jacqueline E.
Victor, J. Chris
Whitney, Cynthia G.
Venue: Vaccine
Publisher: Elsevier BV
Published: 2017-06
Volume: 35
Issue: 25
Pages: 3295-3302
ISSN: 0264-410X (ISSN-L)
DOI: 10.1016/j.vaccine.2017.04.037
PMC: PMC7007298
OpenAlex: W2605758023
Cited by: 102
References: 82
Citations by year: 2026: 6 · 2025: 14 · 2024: 9 · 2023: 17 · 2022: 22 · 2021: 14 · 2020: 7 · 2019: 10 · 2018: 3
FWCI: 1.02
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Vaccine (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
PubMed Central (acceptedVersion, cc-by-nc-nd)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
NORA - Norwegian Open Research Archives (submittedVersion, cc-by-nc-nd)
NORA - Norwegian Open Research Archives (submittedVersion, other-oa)
Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
Funders: GAVI Alliance
World Health Organization
Wellcome Trust (098532/B/12/Z, 203077)
Centers for Disease Control and Prevention (U01IP001048)
Medical Research Council (MR/K012126/1)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Social Sciences › Health › Vaccine Coverage and Hesitancy
Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Keywords: vaccine effectiveness, case-control study, research design, confounding, vaccine introduction, health-seeking behavior, vaccination practices
MeSH terms: Immunogenicity, Vaccine, Female, Humans, Male, Vaccination, Vaccines, Case-Control Studies, Treatment Outcome, Immunization Programs, Control Groups

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Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls

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