{"doi":"10.1056/evidoa2300194","title":"Immunogenicity of 2 or 3 Doses of 9vHPV Vaccine in U.S. Female Individuals 15 to 26 Years of Age","abstract":"BACKGROUND: Within the United States, a 9-valent human papillomavirus (9vHPV) vaccine (HPV-6/11/16/18/31/33/45/52/58) is recommended as a two-dose series among individuals 9 to 14 years of age and a three-dose series among those 15 to 26 years of age. Data comparing two versus three doses of 9vHPV vaccine among individuals 15 to 26 years of age are limited. METHODS: We report on an ongoing, single-blinded, randomized noninferiority trial of the 9vHPV vaccine among individuals 15 to 26 years of age in the United States. Participants were randomly assigned to a two-dose (0 and 6 months) or three-dose (0, 2, and 6 months) schedule. Blood draws to assess antibody titers were planned before the first vaccination and at 1 and 6 months after the final vaccination. The primary outcome was the rate of seroconversion at 1 month after final vaccination. The secondary outcome was the two-dose versus three-dose ratio of antibody geometric mean titers (GMTs) for each of the 9vHPV genotypes at 1 and 6 months after final vaccination. This interim analysis reports results of female participants at 1 month after final vaccination. RESULTS: Of 860 participants screened, 438 were enrolled and randomly assigned to the two-dose (n=217) or three-dose (n=221) group. At 1 month after the final vaccine dose, the seroconversion rate for each of the nine HPV genotypes in the vaccine was 100% among participants in the two-dose group and 99% in the three-dose group. The point estimates of the two-dose versus three-dose ratios of antibody GMTs for eight of the nine HPV genotypes were above unity; the ratio for HPV-45 was 0.86 (95% confidence interval [CI], 0.66 to 1.13). This was also the smallest value for the lower bound of the 95% CI for all nine ratios (ratios above 1 favor the two-dose schedule). No serious adverse events were observed. CONCLUSIONS: In this unplanned interim analysis of U.S. female participants 15 to 26 years of age, two doses of 9vHPV vaccine appear to elicit responses similar to three doses at 1 month postvaccination. We await final results at 6 months following the last vaccine dose. (ClinicalTrials.gov number, NCT03943875.)","journal":"NEJM Evidence","year":2024,"id":455212,"datarank":0.40515152791359127,"base_score":1.9459101490553132,"endowment":1.9459101490553132,"self_citation_contribution":0.29188652235829704,"citation_network_contribution":0.11326500555529424,"self_endowment_contribution":0.29188652235829704,"citer_contribution":0.11326500555529424,"corpus_percentile":null,"corpus_rank":null,"citation_count":6,"citer_count":6,"citers_with_citation_signal":4,"citers_with_endowment":4,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9222,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03943875"]},"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":472574,"name":"Gitika Panicker","orcid":null,"position":1,"is_corresponding":false},{"id":355575,"name":"Elizabeth R. Unger","orcid":"0000-0002-2925-5635","position":2,"is_corresponding":false},{"id":803915,"name":"Richard Rupp","orcid":"0000-0002-9659-1217","position":3,"is_corresponding":false},{"id":339830,"name":"Yong‐Fang Kuo","orcid":"0000-0003-1927-0927","position":4,"is_corresponding":false},{"id":528657,"name":"Abbey B. Berenson","orcid":"0000-0002-5007-1080","position":0,"is_corresponding":true}],"reference_count":25,"raw_metadata":null,"created_at":"2026-07-19T02:03:17.458329Z","pmid":"38320488","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":[]}