Evidence map›Paper›PMID 38049621›Full record

Trial reportNature medicine2023

Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results.

Ruanne V Barnabas, Elizabeth R Brown, Maricianah A Onono, Elizabeth A Bukusi, Betty Njoroge, Rachel L Winer, Denise A Galloway, Leeya F Pinder, Deborah Donnell, Imelda N Wakhungu and 14 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2023. 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. Cited by 65 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 7 pooled it
16.7field-weighted citation impact, top 1% of its field
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

65 citing papers in PubMed, 7 syntheses or guidelines pooled it, 78 citations in OpenAlex.

  1. Guideline
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5 more citing papers are in PubMed but not listed here.

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

24 authors at 8 institutions in 2 countries.

Ruanne V BarnabasDivision of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA. rbarnabas@mgh.harvard.edu.ORCID 0000-0002-1793-6003
Elizabeth R BrownVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-4286-2111
Maricianah A OnonoCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Elizabeth A BukusiCenter for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
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.
Leeya F PinderDepartment of Global Health, University of Washington, Seattle, WA, USA.
Deborah DonnellVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Imelda 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, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Diane G KanjilalDivision of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.ORCID 0000-0001-7300-5556
Daniel PacellaDivision of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.ORCID 0009-0003-3735-2499
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 Laboratory Medicine and Department of Pathology, University of Washington, Seattle, WA, USA.
Torin T SchaafsmaDepartment of Global Health, University of Washington, Seattle, WA, USA.
R Scott McClellandDepartment of Global Health, University of Washington, Seattle, WA, USA.ORCID 0000-0003-2574-4201
Connie CelumDepartment of Global Health, University of Washington, Seattle, WA, USA.
Jared M BaetenDepartment of Global Health, University of Washington, Seattle, WA, USA.ORCID 0000-0001-8242-8438
Nelly R MugoDepartment of Global Health, University of Washington, Seattle, WA, USA.
KEN SHE Study Team
Kenya Medical Research Institute · KEUniversity of Washington · USTechnical University of Mombasa · KEGates Foundation · USFred Hutch Cancer Center · USMassachusetts General Hospital · USHarvard University · USUniversity of Cincinnati · US

Funding

Human Papillomavirus and Polyomavirus Associated Malignancies.R35CA209979 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GALLOWAY, DENISE A. · 2017 to 2023
$6.5M
NCI NIH HHS R35 CA209979
6 · The paper itself

Abstract

Cervical cancer burden is high where prophylactic vaccination and screening coverage are low. We demonstrated in a multicenter randomized, double-blind, controlled trial that single-dose human papillomavirus (HPV) vaccination had high vaccine efficacy (VE) against persistent infection at 18 months in Kenyan women. Here, we report findings of this trial through 3 years of follow-up. Overall, 2,275 healthy women aged 15-20 years were recruited and randomly assigned to receive bivalent (n = 760), nonavalent (n = 758) or control (n = 757) vaccine. The primary outcome was incident-persistent vaccine type-specific cervical HPV infection. The primary evaluation was superiority analysis in the modified intention-to-treat (mITT) HPV 16/18 and HPV 16/18/31/33/45/52/58 cohorts. The trial met its prespecified end points of vaccine type-specific persistent HPV infection. A total of 75 incident-persistent infections were detected in the HPV 16/18 mITT cohort: 2 in the bivalent group, 1 in the nonavalent group and 72 in the control group. Nonavalent VE was 98.8% (95% CI 91.3-99.8%, P < 0.0001) and bivalent VE was 97.5% (95% CI 90.0-99.4%, P < 0.0001). Overall, 89 persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: 5 in the nonavalent group and 84 in the control group; nonavalent VE was 95.5% (95% CI 89.0-98.2%, P < 0.0001). There were no vaccine-related severe adverse events. Three years after vaccination, single-dose HPV vaccination was highly efficacious, safe and conferred durable protection. ClinicalTrials.gov no. NCT03675256 .

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesUterine Cervical NeoplasmsDouble-Blind MethodFemaleHuman papillomavirus 16Human papillomavirus 18HumansKenyaPapillomaviridaePersistent InfectionVaccinationPapillomavirus Vaccines

Identifiers

PMID38049621
PMCPMC10719107
OpenAlexW4389306522

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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.