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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results
Nature Medicine, Year 2023
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Description
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 . © 2023, The Author(s).
Authors & Co-Authors
Onono, Maricianah Atieno
Kenya, Nairobi
Kenya Medical Research Institute
Bukusi, Elizabeth Anne
Kenya, Nairobi
Kenya Medical Research Institute
United States, Seattle
University of Washington
Njoroge, Betty W.
Kenya, Nairobi
Kenya Medical Research Institute
Winer, Rachel L.
United States, Seattle
University of Washington
Donnell, Deborah J.
United States, Seattle
Fred Hutchinson Cancer Center
United States, Seattle
University of Washington
Biwott, Charlene
Kenya, Nairobi
Kenya Medical Research Institute
Kimanthi, Syovata
Kenya, Nairobi
Kenya Medical Research Institute
Heller, Kate B.
United States, Boston
Massachusetts General Hospital
United States, Seattle
University of Washington
Morrison, Susan A.
United States, Seattle
University of Washington
Schaafsma, Torin T.
United States, Seattle
University of Washington
McClelland, Raymond Scott
United States, Seattle
University of Washington
Celum, Connie L.
United States, Seattle
University of Washington
Baeten, Jared M.
United States, Seattle
University of Washington
Mugo, Nelly Rwamba
United States, Seattle
University of Washington
Kenya, Nairobi
Kenya Medical Research Institute
Dull, Peter M.
Unknown Affiliation
Ondrejcek, Lisa
United States, Seattle
Df/net Research
Brown, Elizabeth R.
United States, Seattle
Fred Hutchinson Cancer Center
United States, Seattle
University of Washington
Galloway, Denise A.
United States, Seattle
Fred Hutchinson Cancer Center
Pinder, Leeya F.
United States, Seattle
University of Washington
United States, Cincinnati
University of Cincinnati
Smith, Robin A.
United States, Seattle
Fred Hutchinson Cancer Center
Ondiek, Florence Awuor
Kenya, Nairobi
Kenya Medical Research Institute
Onyango, Kevin Omondi
Kenya, Nairobi
Kenya Medical Research Institute
Owenga, Mildred Anyango
Kenya, Nairobi
Kenya Medical Research Institute
Wakhungu, Imeldah N.
Kenya, Nairobi
Kenya Medical Research Institute
Ambiyo, Faith
United States, Cincinnati
University of Cincinnati
Anyango, Emily
United States, Cincinnati
University of Cincinnati
Chege, David
Kenya, Nairobi
Kenya Medical Research Institute
Gakuo, Stephen
Kenya, Nairobi
Kenya Medical Research Institute
Kiptinness, Catherine
Kenya, Nairobi
Kenya Medical Research Institute
Makena, Linnet
Kenya, Nairobi
Kenya Medical Research Institute
Mbaire, Sarah
Kenya, Nairobi
Kenya Medical Research Institute
Mugo, Edwin
Kenya, Nairobi
Kenya Medical Research Institute
R Mugo, Nelly
United States, Seattle
University of Washington
Kenya, Nairobi
Kenya Medical Research Institute
Njoroge, John Bosco M.
Kenya, Nairobi
Kenya Medical Research Institute
Nyokabi, Jacinta
Kenya, Nairobi
Kenya Medical Research Institute
Oluoch, Lynda Myra
Kenya, Nairobi
Kenya Medical Research Institute
Barnabas, Ruanne Vanessa
United States, Boston
Massachusetts General Hospital
United States, Boston
Harvard Medical School
United States, Boston
Harvard T.h. Chan School of Public Health
Kabare, Emmanuel
Unknown Affiliation
Mwinyikai, Khamis
Unknown Affiliation
Shafi, Juma
Unknown Affiliation
Cherne, Stephen L.
United States, Seattle
University of Washington
Johnson, Rachel E.
United States, Seattle
University of Washington
Lin, John
United States, Seattle
University of Washington
Quame-Amaglo, Justice
United States, Seattle
University of Washington
Rechkina, Elena A.
United States, Seattle
University of Washington
Statistics
Citations: 1
Authors: 45
Affiliations: 8
Identifiers
Doi:
10.1038/s41591-023-02658-0
ISSN:
10788956
Research Areas
Cancer
Disability
Health System And Policy
Study Design
Randomised Control Trial
Cohort Study
Study Approach
Quantitative
Participants Gender
Female