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Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls
Open accessAbstract
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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“Vaccine effectiveness was estimated using the test-negative, case–control study design11,12, applying methodology that was developed earlier to assess duration of protection of the BNT162b213 and mRNA-127314 vaccines in the same population during pre-Omicron SARS-CoV-2 infection waves (Methods).”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [12]
In the citing paper
“Vaccine effectiveness against symptomatic SARS-CoV-2 Omicron (B.1.1.529)1 infection during the large Omicron wave in Qatar, between December 23, 2021 and February 28, 2022, was estimated using the test-negative, case–control study design, a standard design for assessing vaccine effectiveness11,12,36,40.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [12]
In the citing paper
“However, the cohort study design applied earlier to the same population of Qatar yielded findings similar to those of the test-negative case–control design36,38,39, supporting the validity of this standard approach in assessing vaccine effectiveness11,12,36,40.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [12]
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BNT162b2 and mRNA-1273 COVID-19 vaccine effectiveness against the SARS-CoV-2 Delta variant in Qatar
Tang, P., Hasan, M. R., Chemaitelly, H., Yassine, H. M., Benslimane, F. M., Al Khatib, H. A., AlMukdad, S., Coyle, P., Ayoub, H. H., Al Kanaani, Z., et al. (2021) · Nature Medicine · doi:10.1038/s41591-021-01583-4 · Cited by 450
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Metadata
- 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)
- 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
- 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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