Evidence map›Paper›PMID 42115165›Full record

Trial reportNature communications2026

Efficacy and durability of immediate versus delayed single-dose HPV vaccination for persistent infection among young women in Kenya: a randomized, blinded, cross-over clinical trial.

Ruanne V Barnabas, Elizabeth R Brown, Elizabeth A Bukusi, Betty Njoroge, Rachel L Winer, Denise A Galloway, Imeldah N Wakhungu, Charlene Biwott, Syovata Kimanthi, Kate B Heller and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03675256 (KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT03675256 phase4unknown statusnot on this map

KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study

TypeinterventionalSponsorMassachusetts General HospitalRan2018 to 2024Enrolled2,275ConditionsPapillomavirus InfectionsArmsimmediate Gardasil 9, delayed MenVeo vaccine, immediate MenVeo vaccine, delayed Gardasil 9, immediate Cervarix, delayed MenVeo vaccine
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

17 authors.

Ruanne V BarnabasDivision of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA. rbarnabas@mgh.harvard.edu.ORCID http://orcid.org/0000-0002-1793-6003
Elizabeth R BrownVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-4286-2111
Elizabeth A BukusiDepartment of Global Health, University of Washington, Seattle, WA, USA.
Betty NjorogeCenter for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Rachel L WinerDepartment of Epidemiology, University of Washington, Seattle, WA, USA.
Denise A GallowayHuman Biology Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0002-6713-6127
Imeldah N WakhunguCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Charlene BiwottCenter for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Syovata KimanthiCenter for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Kate B HellerDivision of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA.ORCID http://orcid.org/0009-0002-8886-055X
Meighan KrowsDivision of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA.
Susan MorrisonDepartment of Global Health, University of Washington, Seattle, WA, USA.
Elena A RechkinaDepartment of Global Health, University of Washington, Seattle, WA, USA.
Stephen L CherneDepartment of Pathology, University of Washington, Seattle, WA, USA.
R Scott McClellandDepartment of Global Health, University of Washington, Seattle, WA, USA.
Nelly R MugoDepartment of Global Health, University of Washington, Seattle, WA, USA.
Maricianah A OnonoCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.

Funding

Bill and Melinda Gates Foundation (Bill & Melinda Gates Foundation) Inv-062781
6 · The paper itself

Abstract

Evidence is needed for single-dose human papillomavirus (HPV) vaccine efficacy (VE) durability to support vaccination guidelines. In this randomized crossover trial (NCT03675256), healthy young women aged 15-20 years, recruited through community-based screening in Kenya, were randomly allocated to immediate nonavalent or bivalent HPV vaccination and delayed control at month 30/36 (age 17-23 years), or immediate control and delayed nonavalent HPV vaccination. Cervical swabs collected every six months were tested for HPV DNA to determine incident persistent HPV infection. The primary outcome was VE at 54 months, estimated among participants who were HPV naive at enrollment vaccination using Cox proportional hazards models with time-varying covariates for HPV vaccine status and time; negative coefficients for time since vaccination indicate durability. For incident persistent HPV 16/18 infections, 104 were detected: 93 pre-crossover and 11 post-crossover; HPV 16/18 VE was 99.3% (95% CI: 96.2,99.9%). For incident persistent HPV 16/18/31/33/45/52/58, 117 infections occurred: 103 pre-crossover and 14 post-crossover; HPV 16/18/31/33/45/52/58 VE was 98.9% (95% CI: 94.9,99.8%). Coefficients for time since vaccination were -0.0014 (95% CI: -0.0027,-0.0002) for HPV 16/18 and -0.0016 (95% CI: -0.0028,-0.0004) for HPV 16/18/31/33/45/52/58. Single-dose HPV vaccination is highly efficacious ( > 98%) and durable over 54 months in young women.

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesPersistent InfectionVaccinationVaccine EfficacyAdolescentCross-Over StudiesFemaleHuman papillomavirus 16Human papillomavirus 18HumansImmunization ScheduleKenyaYoung AdultPapillomavirus Vaccines

Identifiers

PMID42115165
PMCPMC13377066

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Registered trials

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 OpenQuestion graph.