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Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial.
Fong, Youyi; Huang, Yunda; Benkeser, David; Carpp, Lindsay N; Áñez, Germán; Woo, Wayne; McGarry, Alice; Dunkle, Lisa M; Cho, Iksung; Houchens, Christopher R; Martins, Karen; Jayashankar, Lakshmi; Castellino, Flora; Petropoulos, Christos J; Leith, Andrew; Haugaard, Deanne; Webb, Bill; Lu, Yiwen; Yu, Chenchen; Borate, Bhavesh; van der Laan, Lars W P; Hejazi, Nima S; Randhawa, April K; Andrasik, Michele P; Kublin, James G; Hutter, Julia; Keshtkar-Jahromi, Maryam; Beresnev, Tatiana H; Corey, Lawrence; Neuzil, Kathleen M; Follmann, Dean; Ake, Julie A; Gay, Cynthia L; Kotloff, Karen L; Koup, Richard A; Donis, Ruben O; Gilbert, Peter B.
  • Fong Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Huang Y; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Benkeser D; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Carpp LN; Department of Global Health, University of Washington, Seattle, WA, 98195, USA.
  • Áñez G; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
  • Woo W; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • McGarry A; Novavax, Inc., Gaithersburg, MD, USA.
  • Dunkle LM; Novavax, Inc., Gaithersburg, MD, USA.
  • Cho I; Novavax, Inc., Gaithersburg, MD, USA.
  • Houchens CR; Novavax, Inc., Gaithersburg, MD, USA.
  • Martins K; Novavax, Inc., Gaithersburg, MD, USA.
  • Jayashankar L; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Castellino F; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Petropoulos CJ; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Leith A; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Haugaard D; LabCorp-Monogram Biosciences, South San Francisco, CA, USA.
  • Webb B; Nexelis, Seattle, WA, USA.
  • Lu Y; Nexelis, Seattle, WA, USA.
  • Yu C; Nexelis, Seattle, WA, USA.
  • Borate B; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • van der Laan LWP; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Hejazi NS; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Randhawa AK; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Andrasik MP; Department of Statistics, University of Washington, Seattle, WA, USA.
  • Kublin JG; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Hutter J; Department of Biostatistics, T.H. Chan School of Public Health, Harvard University, Boston, MA, USA.
  • Keshtkar-Jahromi M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Beresnev TH; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Corey L; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Neuzil KM; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD, USA.
  • Follmann D; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD, USA.
  • Ake JA; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD, USA.
  • Gay CL; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Kotloff KL; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
  • Koup RA; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
  • Donis RO; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Gilbert PB; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.
Nat Commun ; 14(1): 331, 2023 01 19.
Article in English | MEDLINE | ID: covidwho-2185838
ABSTRACT
In the PREVENT-19 phase 3 trial of the NVX-CoV2373 vaccine (NCT04611802), anti-spike binding IgG concentration (spike IgG), anti-RBD binding IgG concentration (RBD IgG), and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured two weeks post-dose two are assessed as correlates of risk and as correlates of protection against COVID-19. Analyses are conducted in the U.S. cohort of baseline SARS-CoV-2 negative per-protocol participants using a case-cohort design that measures the markers from all 12 vaccine recipient breakthrough COVID-19 cases starting 7 days post antibody measurement and from 639 vaccine recipient non-cases. All markers are inversely associated with COVID-19 risk and directly associated with vaccine efficacy. In vaccine recipients with nAb ID50 titers of 50, 100, and 7230 international units (IU50)/ml, vaccine efficacy estimates are 75.7% (49.8%, 93.2%), 81.7% (66.3%, 93.2%), and 96.8% (88.3%, 99.3%). The results support potential cross-vaccine platform applications of these markers for guiding decisions about vaccine approval and use.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2023 Document Type: Article Affiliation country: S41467-022-35768-3

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2023 Document Type: Article Affiliation country: S41467-022-35768-3