{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T20:22:15Z","timestamp":1787170935541,"version":"build-2736575974"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"2","funder":[{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,4,13]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>Determining the effect of vaccine-induced immune response on disease risk is an important goal of vaccinology. Typically, immune correlates analyses are conducted prospectively with immune response measured shortly after vaccination and subsequent disease status regressed on immune response. In outbreaks and rare disease settings, collecting samples from all vaccinees is not feasible. The test negative design is a retrospective design used to measure vaccine efficacy where symptomatic individuals who present at a clinic are assessed for relevant disease (cases) or some other disease (controls) and vaccination status ascertained. This article proposes that test negative vaccinees have immune response to vaccine assessed both for relevant (e.g., Ebola) and irrelevant (e.g., vector) proteins. If the latter immune response is unaffected by active (Ebola) infection, and is correlated with the relevant immune response, it can serve as a proxy for the immune response of interest proximal to infection. We show that logistic regression using imputed immune response as the covariate and case disease as outcome can estimate the prospective immune response slope and detail the assumptions needed for unbiased inference. The method is evaluated by simulation under various scenarios including constant and decaying immune response. A simulated dataset motivated by ring vaccination for an ongoing Ebola outbreak is analyzed.<\/jats:p>","DOI":"10.1093\/biostatistics\/kxaa037","type":"journal-article","created":{"date-parts":[[2020,8,18]],"date-time":"2020-08-18T16:08:35Z","timestamp":1597766915000},"page":"507-521","source":"Crossref","is-referenced-by-count":11,"title":["Immune correlates analysis using vaccinees from test negative designs"],"prefix":"10.1093","volume":"23","author":[{"given":"Dean A","family":"Follmann","sequence":"first","affiliation":[{"name":"Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases , Bethesda MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lori","family":"Dodd","sequence":"additional","affiliation":[{"name":"Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases , Bethesda 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assessment of influenza vaccine effectiveness","volume":"184","author":"Sullivan,","year":"2016","journal-title":"American Journal of Epidemiology"},{"key":"2022062217114281400_B16","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1093\/aje\/kww063","article-title":"Invited commentary: beware the test-negative design","volume":"184","author":"Westreich,","year":"2016","journal-title":"American Journal of Epidemiology"},{"key":"2022062217114281400_B17","volume-title":"Preliminary Results on the Efficacy of rVSV-ZEBOV-GP Ebola Vaccine using the Ring Vaccination Strategy in the Control of an Ebola Outbreak in the Democratic Republic of the Congo: An Example of Integration of Research into Epidemic 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