{"entity":{"id":"ken-she","kind":"trial","name":"KEN SHE (single-dose HPV vaccine)","aka":[],"tldr":"One shot of HPV vaccine was 97.5% effective against the two most dangerous HPV types, making it realistic to vaccinate the whole world.","summary":"Vaccine efficacy 97.5% against persistent HPV16/18 infection at 18 months (NEJM Evidence 2022), sustained at 36 months. Together with the IARC India cohort and Costa Rica trial data, it underpinned the WHO 2022 recommendation for one- or two-dose schedules, adopted by more than 60 countries by 2025 and roughly doubling the number of girls a fixed vaccine supply can protect.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03675256","url":"https://clinicaltrials.gov/study/NCT03675256"},{"label":"Single-dose evidence, Lancet Global Health 2024","url":"https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(24)00009-3/fulltext"}],"tags":[],"related":[],"cancers":["cervical","head-and-neck"],"sections":[],"technologies":["hpv-vaccine"],"targets":[],"drugs":["gardasil-9"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ian-frazer"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03675256","phase":"4","setting":"Kenyan women aged 15-20: single dose of bivalent or nonavalent HPV vaccine vs meningococcal control, endpoint persistent HPV16/18 infection","sponsor":"University of Washington / Bill & Melinda Gates Foundation","result":"Single-dose efficacy 97.5% against persistent HPV16/18.","started":"2018-12-19","startedType":"actual","yearReported":2022,"enrolled":2275,"enrolledBasis":"registry","outcomes":[{"endpoint":"Vaccine efficacy against persistent HPV16/18 infection","primary":true,"unit":"%","arms":[{"name":"Single dose nonavalent HPV","value":97.5}],"source":"https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/03-Barnabas-HPV-508.pdf"}],"replication":"IARC India cohort (Basu 2021) and Costa Rica ESCUDDO/CVT data show similar single-dose protection."},"route":"/trials/ken-she/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"}],"technology":[{"id":"hpv-vaccine","kind":"technology","name":"HPV & HBV vaccination","route":"/technologies/hpv-vaccine/"}],"drug":[{"id":"gardasil-9","kind":"drug","name":"Nonavalent HPV vaccine","route":"/drugs/gardasil-9/"}],"person":[{"id":"ian-frazer","kind":"person","name":"Ian Frazer","route":"/people/ian-frazer/"}],"idea":[{"id":"idea-single-dose-hpv-self-sampling-elimination","kind":"idea","name":"Single-dose HPV vaccination plus HPV self-sampling to reach WHO elimination in low-income countries","route":"/ideas/idea-single-dose-hpv-self-sampling-elimination/"}],"bottleneck":[{"id":"b-prevention-adoption","kind":"bottleneck","name":"Prevention we already have is not deployed","route":"/bottlenecks/b-prevention-adoption/"}],"trial":[{"id":"iarc-india-hpv-dose-study","kind":"trial","name":"IARC India HPV vaccine dose study (one, two or three doses)","route":"/trials/iarc-india-hpv-dose-study/"}],"paper":[{"id":"paper-basu-single-dose-hpv-lancet-oncol-2021","kind":"paper","name":"Vaccine efficacy against persistent HPV 16/18 infection at 10 years after one, two and three doses of quadrivalent HPV vaccine in girls in India","route":"/key-papers/paper-basu-single-dose-hpv-lancet-oncol-2021/"}],"roadmap":[{"id":"prevention-roadmap","kind":"roadmap","name":"Cancer prevention roadmap: tobacco control and vaccines → biomarker-guided chemoprevention → interception in carriers","route":"/roadmaps/prevention-roadmap/"},{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}