COVID-19 Vaccine Efficacy in Participants With Weakened Immune Systems From 4 Randomized Controlled Trials-Reference-Cited by-同舟云学术

COVID-19 Vaccine Efficacy in Participants With Weakened Immune Systems From 4 Randomized Controlled Trials

Published:2024-04-10 Issue:2 Volume:79 Page:364-374
ISSN:1058-4838
Container-title:Clinical Infectious Diseases
language:en
Short-container-title:

Author:

Sherman Amy C¹^ORCID,Tuan Jessica²,Cantos Valeria D³,Adeyiga Oladunni⁴,Mahoney Scott⁵,Ortega-Villa Ana M⁶,Tillman Amy⁷,Whitaker Jennifer⁸,Woodward Davis Amanda S⁹,Leav Brett¹⁰,Hirsch Ian¹¹,Sadoff Jerald¹²,Dunkle Lisa M¹³,Gilbert Peter B⁹,Janes Holly E⁹,Kublin James G⁹,Goepfert Paul A¹⁴,Kotloff Karen¹⁵,Rouphael Nadine¹⁶,Falsey Ann R¹⁷,El Sahly Hana M⁸,Sobieszczyk Magdalena E¹⁸,Huang Yunda⁹,Neuzil Kathleen M¹⁹,Corey Lawrence⁹²⁰,Grinsztejn Beatriz²¹,Gray Glenda²²²³,Nason Martha⁶,Baden Lindsey R¹,Gay Cynthia L²⁴

Affiliation:

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

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

3. Division of Infectious Diseases, Emory University , Atlanta, Georgia , USA

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

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

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

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

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

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

10. Moderna Inc. , Cambridge, Massachusetts , USA

11. Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca , Cambridge , United Kingdom

12. Janssen Vaccines and Prevention , Leiden , Netherlands

13. Novavax , Gaithersburg, Maryland , USA

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

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

16. Hope Clinic, Emory University , Atlanta, Georgia , USA

17. Infectious Disease Division, University of Rochester , Rochester, New York , USA

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

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

20. Department of Laboratory Medicine and Pathology, University of Washington , Seattle, Washington , USA

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

22. Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand , Johannesburg , South Africa

23. South African Medical Research Council , Cape Town , South Africa

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

Abstract

Abstract Background Although the severe acute respiratory syndrome coronavirus 2 (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 A post hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, coronavirus disease 2019 (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 individuals starting at 14 days after completion of the primary series through the blinded phase for each of the 4 trials. An analysis of participants living with well-controlled human immunodeficiency virus was conducted using the same methods. Results A total of 3852/30 351 (12.7%) Moderna participants, 3088/29 868 (10.3%) Novavax participants, 3549/32 380 (11.0%) AstraZeneca participants, and 5047/43 788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (vs 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 versus non-TIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with human immunodeficiency virus. Conclusions For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared with those with non-TIS in the 4 COVID-19 vaccine randomized controlled efficacy trials.

Funder

US government

Biomedical Advanced Research and Development Authority

National Institute of Allergy and Infectious Diseases

HIV Vaccine Trials Network

Vaccine Treatment and Evaluation Units

HIV Prevention Trials Network

AIDS Clinical Trials Group

Infectious Diseases Clinical Research Consortium

National Institutes of Health

Publisher

Oxford University Press (OUP)