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Cited by 223Cervical Cancer and HPV ResearchGenital Health and DiseaseReproductive tract infections research

The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.

Efficacy of Single-Dose Human Papillomavirus Vaccination among Young African Women

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Barnabas, Ruanne V., Brown, Elizabeth R., Onono, Maricianah A., Bukusi, Elizabeth A., Njoroge, Betty, Winer, Rachel L., Galloway, Denise A., Pinder, Leeya F., Donnell, Deborah, Wakhungu, Imelda, Congo, Ouma, Biwott, Charlene, Kimanthi, Syovata, Oluoch, Lynda, Heller, Kate B., Leingang, Hannah, Morrison, Susan, Rechkina, Elena, Cherne, Stephen, Schaafsma, Torin T., McClelland, R. Scott, Celum, Connie, Baeten, Jared M., Mugo, Nelly·2022·NEJM Evidence
DOI 10.1056/evidoa2100056PMC PMC9172784
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Abstract

BACKGROUND: Single-dose human papillomavirus (HPV) vaccination, if efficacious, would be tremendously advantageous, simplifying implementation and decreasing costs. METHODS: We 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. RESULTS: Between 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. CONCLUSIONS: Over 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.)

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Figure 1: Randomized trial profile *of the 419 people who were ineligible for randomization, 132 (16%) had a positive pregnancy test, 51 (6%) were not willing to follow study procedures or be randomized, 34 (4%) had a positive rapid HIV diagnostic test, and 172 (21%) met other exclusion criteria. **Complete baseline data includes HPV antibody results at month 0 and HPV DNA results at month 0 and month 3.
Figure 1: Randomized trial profile *of the 419 people who were ineligible for randomization, 132 (16%) had a positive pregnancy test, 51 (6%) were not willing to follow study procedures or be randomized, 34 (4%) had a positive rapid HIV diagnostic test, and 172 (21%) met other exclusion criteria. **Complete baseline data includes HPV antibody results at month 0 and HPV DNA results at month 0 and month 3.CC BY · PubMed Central
Figure 2a: Kaplan-Meier curves for the primary, HPV 16/18 modified intention-to-treat analysis
Figure 2a: Kaplan-Meier curves for the primary, HPV 16/18 modified intention-to-treat analysisCC BY · PubMed Central
Figure 2b: Kaplan-Meier curves for the primary, HPV 16/18/31/33/45/52/58 modified intention-to-treat analysis
Figure 2b: Kaplan-Meier curves for the primary, HPV 16/18/31/33/45/52/58 modified intention-to-treat analysisCC BY · PubMed Central

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Research works printed but not linked: 1

  1. Watson-Jones D Changalucha J Whitworth H et al. Month 24 immunogenicity and safety of 1 2 and 3 doses of Gardasil-9 and Cervarix in Tanzanian girls aged 9-14Y: the DoRIS randomized trial. Presented at the 34th International Papillomavirus Virtual Conference; November 15–19 2021.

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Authors
Barnabas, R. V., Brown, E. R., Onono, M. A., Bukusi, E. A., Njoroge, B., Winer, R. L., Galloway, D. A., Pinder, L. F., Donnell, D., Wakhungu, I., Congo, O., Biwott, C., Kimanthi, S., Oluoch, L., Heller, K. B., Leingang, H., Morrison, S., Rechkina, E., Cherne, S., Schaafsma, T. T., McClelland, R. S., Celum, C., Baeten, J. M., & Mugo, N.
Affiliations
  • Harvard University (US)
  • University of Washington (US)
  • Kenya Medical Research Institute (KE)
  • Fred Hutch Cancer Center (US)
ORCID
Venue
NEJM Evidence
Publisher
Massachusetts Medical Society
Published
2022-04-26
Volume
1
Issue
5
Pages
EVIDoa2100056-EVIDoa2100056
ISSN
2766-5526 (ISSN-L)
DOI
10.1056/evidoa2100056
PMC
PMC9172784
OpenAlex
W4223574449
Cited by
223
References
26
Citations by year
2026: 49 · 2025: 48 · 2024: 54 · 2023: 52 · 2022: 19
FWCI
31.22
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • NEJM Evidence (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion, cc-by)
Funders
  • National Cancer Institute (R35CA209979, T32CA009515)
  • National Institute of Allergy and Infectious Diseases (R01AI038382)
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Health Sciences › Medicine › Surgery › Genital Health and Disease
  • Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
Keywords
HPV vaccine, nonavalent HPV vaccine, bivalent HPV vaccine, vaccine efficacy, persistent HPV infection, HPV 16/18, meningococcal vaccine, young women, Kenya, vaccine safety
MeSH terms
Adolescent, Africa, Uterine Cervical Neoplasms, Female, Humans, Papillomavirus Infections, Papillomavirus Vaccines, Young Adult

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