Résumé
Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health.
Langue d'origine | English |
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Numéro d'article | 104799 |
Journal | eBioMedicine |
Volume | 96 |
DOI | |
Statut de publication | Published - oct. 2023 |
Financement
Funding: This work was supported by National Institutes of Health UM1 AI068614 to LC, GEG for CoVPN Operational Infrastructure; UM1 AI068635 to PBG, YuH, HEJ for CoVPN cross-protocol statistical analyses; K23AI159399 to AMR; UM1 AI069412 to LRB, SRW, P30 AI50410 to CLG; 3UM1AI148575-01S2 to HMES. National Institutes of Health.We are grateful to Victoria Salinas, BA, who provided support through data illustrations, Samuel T. Robinson, PhD, who provided technical writing and editing assistance, and Nicole Na, who provided administrative assistance. Co-authors have reported support for this manuscript from the following entities: National Institutes of Health (AMR, LRB, HMES, PBG, YuH, LC, SRW), AstraZeneca (IH), BARDA (FS), Johnson & Johnson (FS). Funding: This work was supported by National Institutes of Health UM1 AI068614 to LC, GEG for CoVPN Operational Infrastructure; UM1 AI068635 to PBG, YuH, HEJ for CoVPN cross-protocol statistical analyses; K23AI159399 to AMR; UM1 AI069412 to LRB, SRW, P30 AI50410 to CLG; 3UM1AI148575-01S2 to HMES.
Bailleurs de fonds | Numéro du bailleur de fonds |
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National Institutes of Health | UM1 AI069412, P30 AI50410, K23AI159399, 3UM1AI148575-01S2, UM1 AI068635, UM1 AI068614 |
AstraZeneca | |
Johnson and Johnson | |
Biomedical Advanced Research and Development Authority |
ASJC Scopus Subject Areas
- General Biochemistry,Genetics and Molecular Biology