Evidence map›Paper›PMID 35693874›Full record

Trial reportNEJM evidence2022

Efficacy of single-dose HPV vaccination among young African women.

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 Wakhungu and 14 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in NEJM evidence, 2022. 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 130 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 5 pooled it
27.6field-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

130 citing papers in PubMed, 5 syntheses or guidelines pooled it, 192 citations in OpenAlex.

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70 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 6 institutions in 3 countries.

Ruanne V BarnabasDepartment of Global Health, University of Washington, Seattle, USA.
Elizabeth R BrownDepartment of Biostatistics, University of Washington, Seattle, USA.
Maricianah A OnonoCenter for Microbiology Research, Kenya Medical Research Institute, Kenya.
Elizabeth A BukusiDepartment of Global Health, University of Washington, Seattle, USA.
Betty NjorogeCenter for Clinical Research, Kenya Medical Research Institute, Kenya.
Rachel L WinerDepartment of Epidemiology, University of Washington, Seattle, USA.
Denise A GallowayPublic Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, USA.
Leeya F PinderDepartment of Obstetrics and Gynecology, University of Washington, Seattle, USA.
Deborah DonnellDepartment of Global Health, University of Washington, Seattle, USA.
Imelda WakhunguCenter for Microbiology Research, Kenya Medical Research Institute, Kenya.
Ouma CongoCenter for Clinical Research, Kenya Medical Research Institute, Kenya.
Charlene BiwottCenter for Clinical Research, Kenya Medical Research Institute, Kenya.
Syovata KimanthiCenter for Clinical Research, Kenya Medical Research Institute, Kenya.
Linda OluochCenter for Clinical Research, Kenya Medical Research Institute, Kenya.
Kate B HellerDepartment of Global Health, University of Washington, Seattle, USA.
Hannah LeingangDepartment of Global Health, University of Washington, Seattle, USA.
Susan MorrisonDepartment of Global Health, University of Washington, Seattle, USA.
Elena RechkinaDepartment of Global Health, University of Washington, Seattle, USA.
Stephen CherneDepartment of Pathology, University of Washington, Seattle, USA.
Torin T SchaafsmaDepartment of Global Health, University of Washington, Seattle, USA.
R Scott McClellandDepartment of Global Health, University of Washington, Seattle, USA.
Connie CelumDepartment of Global Health, University of Washington, Seattle, USA.
Jared M BaetenDepartment of Global Health, University of Washington, Seattle, USA.
Nelly MugoDepartment of Global Health, University of Washington, Seattle, USA.
University of Washington · USKenya Medical Research Institute · KECancer Research Center · USCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZAGilead Sciences (United States) · USMassachusetts General Hospital · US

Funding

TRAINING IN CANCER BIOLOGY &TRANSPLANTATIONT32CA009515 · NCI · UNIVERSITY OF WASHINGTON · PI NANCY ELLEN DAVIDSON, Effie W Petersdorf · 1985 to 2026
$16.2M
Human Papillomavirus and Polyomavirus Associated Malignancies.R35CA209979 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GALLOWAY, DENISE A. · 2017 to 2023
$6.5M
HPV CAPSID ANTIBODIESR01AI038382 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GALLOWAY, DENISE A. · 1995 to 2020
$4.4M
NCI NIH HHS R35 CA209979NCI NIH HHS T32 CA009515NIAID NIH HHS R01 AI038382
6 · The paper itself

Abstract

backgroundSingle-dose human papillomavirus (HPV) vaccination, if efficacious, would be tremendously advantageous, simplifying implementation and decreasing costs.

methodsWe performed a randomized, multicenter, double-blind, controlled trial of single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11 infection) or bivalent (HPV 16/18 infection) HPV vaccination compared with meningococcal vaccination among Kenyan women 15 to 20 years of age. Enrollment and 6-monthly cervical swabs and a month 3 vaginal swab were tested for HPV deoxyribonucleic acid (DNA). Enrollment sera were tested for HPV antibodies. The modified intent-to-treat (mITT) cohort comprised participants who had an HPV antibody-negative result at enrollment and an HPV DNA-negative result at enrollment and month 3. The primary outcome was incident persistent vaccine-type HPV infection by month 18.

resultsBetween December 2018 and June 2021, 2275 women were randomly assigned and followed. A total of 758 participants received the nonavalent HPV vaccine, 760 received the bivalent HPV vaccine, and 757 received the meningococcal vaccine; retention was 98%. Thirty-eight incident persistent infections were detected in the HPV 16/18 mITT cohort: one each among participants assigned to the bivalent and nonavalent groups and 36 among those assigned to the meningococcal group. Nonavalent vaccine efficacy (VE) was 97.5% (95% confidence interval [CI], 81.7 to 99.7%; P≤0.0001), and bivalent VE was 97.5% (95% CI, 81.6 to 99.7%; P≤0.0001). Thirty-three incident persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: four in the nonavalent group and 29 in the meningococcal group. Nonavalent VE for HPV 16/18/31/33/45/52/58 was 88.9% (95% CI, 68.5 to 96.1; P<0.0001). The rate of serious adverse events was 4.5% to 5.2% by group.

conclusionsOver the 18-month timeframe we studied, single-dose bivalent and nonavalent HPV vaccines were each highly effective in preventing incident persistent oncogenic HPV infection, similar to multidose regimens. (Funded by the National Institutes of Health, the Bill and Melinda Gates Foundation, and the University of Washington; ClinicalTrials.gov number, NCT03675256.)

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesAdolescentAfricaFemaleHumansUterine Cervical NeoplasmsYoung AdultPapillomavirus Vaccines

Identifiers

PMID35693874
PMCPMC9172784
OpenAlexW4223574449

What OpenQuestion holds

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LicenceCC BY
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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.