Evidence map›Paper›PMID 38598658›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

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

Amy C Sherman, Jessica Tuan, Valeria D Cantos, Oladunni Adeyiga, Scott Mahoney, Ana M Ortega-Villa, Amy Tillman, Jennifer Whitaker, Amanda S Woodward Davis, Brett Leav and 20 more

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Historical Advances in Clinical Trial Design and Expanding Representation as the New Frontier for Innovation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Amy C ShermanDepartment of Medicine, Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-6075-3990
Jessica TuanYale School of Medicine, Section of Infectious Diseases, New Haven, Connecticut, USA.
Valeria D CantosDivision of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
Oladunni AdeyigaDepartment of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, California, USA.
Scott MahoneyDepartment of Medicine, University of Cape Town, Desmond Tutu HIV Centre, Cape Town, South Africa.
Ana M Ortega-VillaNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Amy TillmanFrederick National Laboratory for Cancer Research, Clinical Monitoring Research Program Directorate, Frederick, Maryland, USA.
Jennifer WhitakerDepartment of Molecular Virology and Microbiology and Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Amanda S Woodward DavisVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Brett LeavModerna Inc., Cambridge, Massachusetts, USA.
Ian HirschVaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
Jerald SadoffJanssen Vaccines and Prevention, Leiden, Netherlands.
Lisa M DunkleNovavax, Gaithersburg, Maryland, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Holly E JanesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Paul A GoepfertDepartment of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Karen KotloffDepartment of Pediatrics and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Nadine RouphaelHope Clinic, Emory University, Atlanta, Georgia, USA.
Ann R FalseyInfectious Disease Division, University of Rochester, Rochester, New York, USA.
Hana M El SahlyDepartment of Molecular Virology and Microbiology and Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Magdalena E SobieszczykDepartment of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Yunda HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Beatriz GrinsztejnNational Institute of Infectious Diseases-Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
Glenda GrayPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Martha NasonNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Lindsey R BadenDepartment of Medicine, Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Cynthia L GayDepartment 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.

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
VTEU SupplementUM1AI148689 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Karen L. Kotloff · 2020 to 2026
$52.7M
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
Vaccine and Treatment Evaluation Units - DMID 21-0012UM1AI148576 · NIAID · EMORY UNIVERSITY · PI Nadine Georges Rouphael, Carlos del Rio · 2020 to 2026
$41.7M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric StudyUM1AI148450 · NIAID · UNIVERSITY OF ROCHESTER · PI Angela Ramona Branche, Ann R Falsey · 2020 to 2026
$20.6M
Columbia Collaborative HIV/AIDS Clinical Trials UnitU01AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2007 to 2011
$15.4M
AIDS Clinical Trials GroupBiomedical Advanced Research and Development AuthorityHIV Prevention Trials NetworkHIV Vaccine Trials NetworkInfectious Diseases Clinical Research ConsortiumNational Institute of Allergy and Infectious DiseasesNCATS NIH HHS UL1 TR001863NIAID NIH HHS R38 AI174306NIAID NIH HHS U01 AI069470NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069476NIAID NIH HHS UM1 AI148450NIAID NIH HHS UM1 AI148576NIAID NIH HHS UM1 AI148684NIAID NIH HHS UM1 AI148689NIA NIH HHS U54 AG062334NIH HHS UM1 AI068614US governmentVaccine Treatment and Evaluation Units
6 · The paper itself

Abstract

backgroundAlthough 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.

methodsA 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.

resultsA 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.

conclusionsFor 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.

Indexed as

COVID-19COVID-19 VaccinesSARS-CoV-2Vaccine EfficacyAdultAgedFemaleHumansImmunocompromised HostMaleMiddle AgedRandomized Controlled Trials as TopicCOVID-19 VaccinesCOVID-19HIVimmunocompromisedvaccinevaccine efficacy

Identifiers

PMID38598658
PMCPMC11327800

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.