{"doi":"10.1093/cid/ciae192","title":"COVID-19 Vaccine Efficacy in Participants With Weakened Immune Systems From 4 Randomized Controlled Trials","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.","journal":"Clinical Infectious Diseases","year":2024,"id":455654,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":6,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.6038,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":950032,"name":"Jessica Tuan","orcid":"0000-0001-7775-2444","position":1,"is_corresponding":false},{"id":104989,"name":"Valeria D Cantos","orcid":"0000-0001-5447-3469","position":2,"is_corresponding":false},{"id":1241292,"name":"Oladunni Adeyiga","orcid":"0000-0003-0019-0169","position":3,"is_corresponding":false},{"id":853993,"name":"Scott Mahoney","orcid":null,"position":4,"is_corresponding":false},{"id":429837,"name":"Ana M. Ortega‐Villa","orcid":"0000-0002-5589-9557","position":5,"is_corresponding":false},{"id":728659,"name":"Amy Tillman","orcid":"0000-0002-1777-9597","position":6,"is_corresponding":false},{"id":844021,"name":"Jennifer A. Whitaker","orcid":"0000-0002-7727-6086","position":7,"is_corresponding":false},{"id":686502,"name":"Amanda S. Woodward Davis","orcid":"0000-0002-6901-8271","position":8,"is_corresponding":false},{"id":218082,"name":"Brett Leav","orcid":"0000-0003-0907-0817","position":9,"is_corresponding":false},{"id":553744,"name":"Ian Hirsch","orcid":"0000-0003-1232-9770","position":10,"is_corresponding":false},{"id":328876,"name":"Jerald Sadoff","orcid":"0000-0002-4839-3013","position":11,"is_corresponding":false},{"id":804379,"name":"Lisa M. Dunkle","orcid":"0000-0003-2973-0245","position":12,"is_corresponding":false},{"id":96350,"name":"Peter B. 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Sobieszczyk","orcid":"0000-0002-7112-3118","position":21,"is_corresponding":false},{"id":331739,"name":"Yunda Huang","orcid":"0000-0003-1546-6172","position":22,"is_corresponding":false},{"id":38212,"name":"Kathleen M. Neuzil","orcid":"0000-0001-9480-2714","position":23,"is_corresponding":false},{"id":96348,"name":"Lawrence Corey","orcid":"0000-0002-2179-2436","position":24,"is_corresponding":false},{"id":314047,"name":"Beatriz Grinsztejn","orcid":"0000-0003-3692-5155","position":25,"is_corresponding":false},{"id":314444,"name":"Glenda Gray","orcid":"0000-0003-4649-1477","position":26,"is_corresponding":false},{"id":105609,"name":"Martha Nason","orcid":"0000-0002-0110-881X","position":27,"is_corresponding":false},{"id":3841,"name":"Lindsey R. Baden","orcid":null,"position":28,"is_corresponding":false},{"id":249715,"name":"Cynthia L. Gay","orcid":"0000-0002-3620-3059","position":29,"is_corresponding":false},{"id":237966,"name":"Amy C Sherman","orcid":"0000-0002-6075-3990","position":0,"is_corresponding":true}],"reference_count":42,"raw_metadata":null,"created_at":"2026-07-19T02:03:22.974789Z","pmid":"38598658","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}