{"doi":"10.1093/infdis/jiaf572","title":"A Test-Negative Design for Immune Correlates Approximates a Traditional Exposure-Proximal Design but Requires Far Fewer Blood Samples","abstract":"Traditional vaccine clinical trials sample blood from all participants. In contrast, the test-negative immune correlates (TNIC) design only samples blood from participants who develop symptoms. We compared traditional to test-negative immune correlates methods in the mRNA-1273 severe acute respiratory syndrome coronavirus 2 vaccine efficacy clinical trial. Using a neutralizing antibody assay, hazard ratios were 0.48 (95% confidence interval [CI], .29-.73) and 0.55 (95% CI, .28-1.06) for traditional and test-negative methods, respectively. Analogous ratios for binding antibody assay were 0.69 (95% CI, .52-.94) and 0.78 (95% CI, .50-1.20). The results support use of the logistically simpler TNIC design.","journal":"The Journal of Infectious Diseases","year":2025,"id":583155,"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":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9529,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1302650,"name":"Lauren Dang","orcid":"0009-0003-2865-1155","position":1,"is_corresponding":false},{"id":1109695,"name":"Eric Chun‐Pu Chu","orcid":"0000-0002-0893-556X","position":2,"is_corresponding":false},{"id":231228,"name":"Jonathan Fintzi","orcid":"0000-0002-6361-702X","position":3,"is_corresponding":false},{"id":30696,"name":"Holly Janes","orcid":"0000-0002-3237-984X","position":4,"is_corresponding":false},{"id":96350,"name":"Peter B. Gilbert","orcid":"0000-0002-2662-9427","position":5,"is_corresponding":false},{"id":659023,"name":"Leah Andrews","orcid":"0000-0002-3418-9468","position":6,"is_corresponding":false},{"id":846676,"name":"Leonid Serebryannyy","orcid":"0000-0003-0213-1779","position":7,"is_corresponding":false},{"id":843102,"name":"Robin Carroll","orcid":null,"position":8,"is_corresponding":false},{"id":218077,"name":"Bob C. Lin","orcid":"0000-0002-1373-1406","position":9,"is_corresponding":false},{"id":290824,"name":"Richard A. Koup","orcid":"0000-0002-3090-7282","position":10,"is_corresponding":false},{"id":1495784,"name":"Jon Toma","orcid":null,"position":11,"is_corresponding":false},{"id":1495785,"name":"L Weiping Deng","orcid":null,"position":12,"is_corresponding":false},{"id":636335,"name":"Frances Priddy","orcid":"0000-0002-2533-3982","position":13,"is_corresponding":false},{"id":646754,"name":"Avika Dixit","orcid":"0000-0002-8381-3298","position":14,"is_corresponding":false},{"id":98417,"name":"Honghong Zhou","orcid":null,"position":15,"is_corresponding":false},{"id":3841,"name":"Lindsey R. Baden","orcid":null,"position":16,"is_corresponding":false},{"id":98392,"name":"Hana M. El Sahly","orcid":"0000-0003-0489-0074","position":17,"is_corresponding":false},{"id":390353,"name":"Dean Follmann","orcid":"0000-0003-4073-0393","position":0,"is_corresponding":true}],"reference_count":12,"raw_metadata":null,"created_at":"2026-07-19T02:59:03.725721Z","pmid":"41287255","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":[]}