{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T22:38:42Z","timestamp":1792363122581,"version":"4.4.0"},"reference-count":58,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>SARS-CoV-2 viral load (VL) in the nasopharynx is difficult to quantify and standardize across settings, but it may inform transmission potential and disease severity.<\/jats:p><\/jats:sec>Objective<\/jats:title>To characterize VL at COVID-19 diagnosis among previously uninfected and unvaccinated individuals by evaluating the association of demographic and clinical characteristics, viral variant, and trial with VL, as well as the ability of VL to predict severe disease.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This secondary cross-protocol analysis used individual-level data from placebo recipients from 4 harmonized, phase 3 COVID-19 vaccine efficacy trials sponsored by Moderna, AstraZeneca, Janssen, and Novavax. Participants were SARS-CoV-2 negative at baseline and acquired COVID-19 during the blinded phase of the trials. The setting included the US, Brazil, South Africa, Colombia, Argentina, Peru, Chile, and Mexico; start dates were July 27, 2020, to December 27, 2020; data cutoff dates were March 26, 2021, to July 30, 2021. Statistical analysis was performed from November 2022 to June 2023.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>Linear regression was used to assess the association of demographic and clinical characteristics, viral variant, and trial with polymerase chain reaction\u2013measured log10<\/jats:sub> VL in nasal and\/or nasopharyngeal swabs taken at the time of COVID-19 diagnosis.<\/jats:p><\/jats:sec>Results<\/jats:title>Among 1667 participants studied (886 [53.1%] male; 995 [59.7%] enrolled in the US; mean [SD] age, 46.7 [14.7] years; 204 [12.2%] aged 65 years or older; 196 [11.8%] American Indian or Alaska Native, 150 [9%] Black or African American, 1112 [66.7%] White; 762 [45.7%] Hispanic or Latino), median (IQR) log10<\/jats:sub> VL at diagnosis was 6.18 (4.66-7.12) log10<\/jats:sub> copies\/mL. Participant characteristics and viral variant explained only 5.9% of the variability in VL. The independent factor with the highest observed differences was trial: Janssen participants had 0.54 log10<\/jats:sub> copies\/mL lower mean VL vs Moderna participants (95% CI, 0.20 to 0.87 log10<\/jats:sub> copies\/mL lower). In the Janssen study, which captured the largest number of COVID-19 events and variants and used the most intensive post-COVID surveillance, neither VL at diagnosis nor averaged over days 1 to 28 post diagnosis was associated with COVID-19 severity.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this study of placebo recipients from 4 randomized phase 3 trials, high variability was observed in SARS-CoV-2 VL at the time of COVID-19 diagnosis, and only a fraction was explained by individual participant characteristics or viral variant. These results suggest challenges for future studies of interventions seeking to influence VL and elevates the importance of standardized methods for specimen collection and viral load quantitation.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.12835","type":"journal-article","created":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T15:33:34Z","timestamp":1716478414000},"page":"e2412835","source":"Crossref","is-referenced-by-count":8,"title":["SARS-CoV-2 Viral Load in the Nasopharynx at Time of First Infection Among Unvaccinated Individuals"],"prefix":"10.1001","volume":"7","author":[{"given":"Leigh H.","family":"Fisher","sequence":"first","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia Jin","family":"Kee","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert","family":"Liu","sequence":"additional","affiliation":[{"name":"Bridge HIV, San Francisco Department of Public Health, San Francisco, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia M.","family":"Espinosa","sequence":"additional","affiliation":[{"name":"University of South Florida Morsani College of Medicine, Tampa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"April K.","family":"Randhawa","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Ludwig","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig 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