{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T12:44:51Z","timestamp":1767876291808,"version":"3.49.0"},"reference-count":85,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T00:00:00Z","timestamp":1755734400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100023581","name":"National Science Foundation Graduate Research Fellowship Program","doi-asserted-by":"publisher","award":["DGE-2140004"],"award-info":[{"award-number":["DGE-2140004"]}],"id":[{"id":"10.13039\/100023581","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Infectious Diseases Clinical Research Consortium leadership group 5","award":["UM1 AI148684-03"],"award-info":[{"award-number":["UM1 AI148684-03"]}]},{"name":"AIDS Clinical Trials Group Leadership and Operations Center","award":["UM1 AI 68636"],"award-info":[{"award-number":["UM1 AI 68636"]}]},{"name":"HIV Prevention Trials Network Leadership and Operations Center","award":["UM1 AI 68619"],"award-info":[{"award-number":["UM1 AI 68619"]}]},{"name":"HVTN Laboratory Center","award":["UM1 AI 68618"],"award-info":[{"award-number":["UM1 AI 68618"]}]},{"name":"Statistics and Data Management Center","award":["UM1 AI 68635"],"award-info":[{"award-number":["UM1 AI 68635"]}]},{"name":"Leadership and Operations Center","award":["UM1 AI 68614HVTN"],"award-info":[{"award-number":["UM1 AI 68614HVTN"]}]},{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["75A50120C00034"],"award-info":[{"award-number":["75A50120C00034"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Negative control outcomes (NCOs) are useful tools for hidden bias detection, but empirical evidence validating NCOs for COVID-19 is lacking. To address this gap, we examined the blinded phase of the randomized, placebo-controlled Coronavirus Vaccine Efficacy (COVE; NCT04470427) trial of the mRNA-1273 COVID-19 vaccine. We confirmed that acute respiratory illness with a positive test for a non-SARS-CoV-2 respiratory pathogen on a multiplex PCR panel was a valid NCO for COVID-19, considering that it was unaffected by vaccination (vaccine efficacy, VE\u00a0=\u00a03.3% (95% CI, \u221222.3 to 23.6)) yet strongly associated with COVID-19 (odds ratio\u00a0=\u00a02.95 (95% CI, 2.00, 4.24)). Subsequently, we leveraged non-SARS-CoV-2 infections to detect bias in time-varying VE estimates from COVE\u2019s blinded and booster phases. Balanced incidence of non-SARS-CoV-2 infection between vaccinated and unvaccinated COVID-19-free risk sets suggested low selection bias in VE estimates of two-dose mRNA-1273 against COVID-19 during the blinded phase (VE\u00a0=\u00a092.5% (95% CI, 88.8, 94.9) 14\u00a0days post-dose-two, stable for 5\u00a0months). In COVE\u2019s booster phase, higher non-SARS-CoV-2 incidence was observed after the single booster (intensity ratio, IR\u00a0=\u00a02.38 (95% CI, 1.75, 3.25) 14\u00a0days post-boost), suggesting that booster VE estimates may underestimate the true VE against COVID-19. Our findings demonstrate the potential of off-target infections for unraveling complex biases in COVID-19 vaccine studies.<\/jats:p>\n                  <jats:p>Trial registration: NCT04470427, https:\/\/clinicaltrials.gov\/study\/NCT04470427<\/jats:p>","DOI":"10.1093\/aje\/kwaf176","type":"journal-article","created":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T11:37:58Z","timestamp":1755603478000},"page":"168-177","source":"Crossref","is-referenced-by-count":0,"title":["Validating and leveraging non-SARS-CoV-2 respiratory infection as a negative control outcome in a phase 3 COVID-19 vaccine trial with extended observational follow-up"],"prefix":"10.1093","volume":"195","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-3713-4489","authenticated-orcid":false,"given":"Ethan","family":"Ashby","sequence":"first","affiliation":[{"name":"Department of Biostatistics, University of Washington , Seattle, WA 98195 ,","place":["United States"]},{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center , Seattle, WA 98109 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3237-984X","authenticated-orcid":false,"given":"Holly","family":"Janes","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center , Seattle, WA 98109 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4073-0393","authenticated-orcid":false,"given":"Dean","family":"Follmann","sequence":"additional","affiliation":[{"name":"Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases , Bethesda, MD 20892-9820 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2662-9427","authenticated-orcid":false,"given":"Peter B","family":"Gilbert","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center , Seattle, WA 98109 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Honghong","family":"Zhou","sequence":"additional","affiliation":[{"name":"Infectious Disease Development, Moderna, Inc. , Cambridge, MA 02142 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaowei","family":"Wang","sequence":"additional","affiliation":[{"name":"Infectious Disease Development, Moderna, Inc. , Cambridge, MA 02142 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9390-230X","authenticated-orcid":false,"given":"Bethany","family":"Girard","sequence":"additional","affiliation":[{"name":"Infectious Disease Development, Moderna, Inc. , Cambridge, MA 02142 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frances","family":"Priddy","sequence":"additional","affiliation":[{"name":"Infectious Disease Development, Moderna, Inc. , Cambridge, MA 02142 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1279-3741","authenticated-orcid":false,"given":"James G","family":"Kublin","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center , Seattle, WA 98109 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2179-2436","authenticated-orcid":false,"given":"Lawrence","family":"Corey","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center , Seattle, WA 98109 ,","place":["United States"]},{"name":"Department of Laboratory Medicine and Pathology, University of Washington , Seattle, WA 98115 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9480-2714","authenticated-orcid":false,"given":"Kathleen M","family":"Neuzil","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development and Global Health, University of Maryland School of Medicine , Baltimore, MD 21201-1509 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lindsey R","family":"Baden","sequence":"additional","affiliation":[{"name":"Brigham and Women\u2019s Hospital, Harvard Medical School , Boston, MA 02115 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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, TX 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