{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T18:23:58Z","timestamp":1787163838961,"version":"build-2736575974"},"reference-count":12,"publisher":"Oxford University Press (OUP)","issue":"3","funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["HHSN261201500003I"],"award-info":[{"award-number":["HHSN261201500003I"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["75N91019D00024"],"award-info":[{"award-number":["75N91019D00024"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Biostatistics Research Branch"},{"DOI":"10.13039\/100016820","name":"Vaccine Research Center","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016820","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100030692","name":"Intramural Research Program","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100030692","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Traditional vaccine clinical trials sample blood from all participants. In contrast, the test-negative immune correlates (TNIC) design only samples blood from participants who develop symptoms. We compared traditional to test-negative immune correlates methods in the mRNA-1273 severe acute respiratory syndrome coronavirus 2 vaccine efficacy clinical trial. Using a neutralizing antibody assay, hazard ratios were 0.48 (95% confidence interval [CI], .29\u2013.73) and 0.55 (95% CI, .28\u20131.06) for traditional and test-negative methods, respectively. Analogous ratios for binding antibody assay were 0.69 (95% CI, .52\u2013.94) and 0.78 (95% CI, .50\u20131.20). The results support use of the logistically simpler TNIC design.<\/jats:p>","DOI":"10.1093\/infdis\/jiaf572","type":"journal-article","created":{"date-parts":[[2025,11,13]],"date-time":"2025-11-13T13:08:20Z","timestamp":1763039300000},"page":"e646-e650","source":"Crossref","is-referenced-by-count":2,"title":["A Test-Negative Design for Immune Correlates Approximates a Traditional Exposure-Proximal Design but Requires Far Fewer Blood Samples"],"prefix":"10.1093","volume":"233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4073-0393","authenticated-orcid":false,"given":"Dean","family":"Follmann","sequence":"first","affiliation":[{"name":"Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Dang","sequence":"additional","affiliation":[{"name":"Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Chu","sequence":"additional","affiliation":[{"name":"Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research , Frederick, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Fintzi","sequence":"additional","affiliation":[{"name":"Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly","family":"Janes","sequence":"additional","affiliation":[{"name":"Vaccine Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2662-9427","authenticated-orcid":false,"given":"Peter B","family":"Gilbert","sequence":"additional","affiliation":[{"name":"Vaccine Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3418-9468","authenticated-orcid":false,"given":"Leah I B","family":"Andrews","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, School of Public Health, University of Washington , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonid","family":"Serebryannyy","sequence":"additional","affiliation":[{"name":"Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland 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ModernaFP and ADClinical Development, Moderna , Cambridge, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Honghong","family":"Zhou","sequence":"additional","affiliation":[{"name":"Biometrics Department, ModernaFP and ADClinical Development, Moderna , Cambridge, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsey","family":"Baden","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0489-0074","authenticated-orcid":false,"given":"Hana M","family":"El Sahly","sequence":"additional","affiliation":[{"name":"Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine , Houston, Texas 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