COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials.

COVID-19 HIV Vaccine immunocompromised vaccine efficacy

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
10 Apr 2024
Historique:
received: 28 12 2023
revised: 20 03 2024
accepted: 28 03 2024
medline: 10 4 2024
pubmed: 10 4 2024
entrez: 10 4 2024
Statut: aheadofprint

Résumé

Although the SARS-CoV-2 vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions. A post-hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, COVID-19 vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a "tempered immune system" (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS (NTIS) individuals starting at 14 days after completion of the primary series through the blinded phase for each of the four trials. An analysis of participants living with well-controlled HIV was conducted using the same methods. 3,852/30,351 (12.7%) Moderna participants, 3,088/29,868 (10.3%) Novavax participants, 3,549/32,380 (11.0%) AstraZeneca participants, and 5,047/43,788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (versus placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants vs NTIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with HIV. For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared to those with non-tempered immune systems in the four COVID-19 vaccine randomized controlled efficacy trials.

Sections du résumé

BACKGROUND BACKGROUND
Although the SARS-CoV-2 vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions.
METHODS METHODS
A post-hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, COVID-19 vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a "tempered immune system" (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS (NTIS) individuals starting at 14 days after completion of the primary series through the blinded phase for each of the four trials. An analysis of participants living with well-controlled HIV was conducted using the same methods.
RESULTS RESULTS
3,852/30,351 (12.7%) Moderna participants, 3,088/29,868 (10.3%) Novavax participants, 3,549/32,380 (11.0%) AstraZeneca participants, and 5,047/43,788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (versus placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants vs NTIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with HIV.
CONCLUSIONS CONCLUSIONS
For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared to those with non-tempered immune systems in the four COVID-19 vaccine randomized controlled efficacy trials.

Identifiants

DOI: 10.1093/cid/ciae192 PMID: 38598658
pubmed: 38598658
pii: 7643769
doi: 10.1093/cid/ciae192
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

Auteurs

Amy Sherman (A)

Brigham and Women's Hospital, Harvard Medical School, Department of Medicine, Division of Infectious Diseases, Boston, MA, USA.
ORCID: 0000-0002-6075-3990

Jessica Tuan (J)

Yale School of Medicine, Section of Infectious Diseases, New Haven, CT, USA.

Valeria D Cantos (VD)

Emory University, Division of Infectious Diseases, Atlanta, GA, USA.

Oladunni Adeyiga (O)

University of California, Los Angeles, Department of Medicine, Division of Infectious Diseases, Los Angeles, CA, USA.

Scott Mahoney (S)

University of Cape Town, Desmond Tutu HIV Centre, Department of Medicine, Cape Town, South Africa.

Ana M Ortega-Villa (AM)

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Amy Tillman (A)

Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.

Jennifer Whitaker (J)

Baylor College of Medicine, Department of Molecular Virology and Microbiology and Section of Infectious Diseases, Department of Medicine, Houston, TX, USA.

Amanda S Woodward Davis (AS)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

Brett Leav (B)

Moderna Inc., Cambridge, MA, USA.

Ian Hirsch (I)

Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.

Jerald Sadoff (J)

Janssen Vaccines and Prevention, Leiden, Netherlands.

Lisa M Dunkle (LM)

Novavax, Gaithersburg, MD, USA.

Peter B Gilbert (PB)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

Holly E Janes (HE)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

James G Kublin (JG)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

Paul A Goepfert (PA)

University of Alabama at Birmingham, Department of Medicine, Birmingham, AL, USA.

Karen Kotloff (K)

University of Maryland School of Medicine, Department of Pediatrics and the Center for Vaccine Development and Global Health, Baltimore, MD, USA.

Nadine Rouphael (N)

Hope Clinic, Emory University, Atlanta, GA, USA.

Ann R Falsey (AR)

University of Rochester, Infectious Disease Division, Rochester, NY, USA.

Hana M El Sahly (HM)

Baylor College of Medicine, Department of Molecular Virology and Microbiology and Section of Infectious Diseases, Department of Medicine, Houston, TX, USA.

Magdalena E Sobieszczyk (ME)

Columbia University Irving Medical Center, Department of Medicine, New York, NY, USA.

Yunda Huang (Y)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

Kathleen M Neuzil (KM)

University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.

Lawrence Corey (L)

University of Washington, Department of Laboratory Medicine and Pathology, Seattle, WA, USA.
Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

Beatriz Grinsztejn (B)

National Institute of Infectious Diseases-Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.

Glenda Gray (G)

University of the Witwatersrand, Perinatal HIV Research Unit, Faculty of Health Sciences, Johannesburg, South Africa; South African Medical Research Council, Cape Town, South Africa.

Martha Nason (M)

National Institute of Allergy and Infectious Diseases, National Institutes of Health Bethesda, MD, USA.

Lindsey R Baden (LR)

Brigham and Women's Hospital, Harvard Medical School, Department of Medicine, Division of Infectious Diseases, Boston, MA, USA.

Cynthia L Gay (CL)

University of North Carolina at Chapel Hill School of Medicine, Department of Medicine, Division of Infectious Diseases, UNC HIV Cure Center, Chapel Hill, NC, USA.

Classifications MeSH