Efficacy of Single-Dose Human Papillomavirus Vaccination among Young African Women
Open accessAbstract
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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Initial results from a vaccine trial in Kenya designed to compare the protection of single-dose versus multi-dose HPV vaccination corroborate the findings on single-dose HPV vaccination.
“Recently, initial results from a vaccine trial in Kenya12 designed to compare the protection of single-dose versus multi-dose HPV vaccination corroborate these findings.”
From Evidence-based impact projections of single-dose human papillomavirus vaccination in India: a modelling study (2022) · cites this paper as [12]
The Discussion reports that the Kenyan trial’s initial 18-month results showed high protection from single-dose HPV vaccination, building on earlier observational findings. But the Methods (Trial design and Oversight) state that the trial compared single-dose HPV vaccines with meningococcal vaccination, not with multidose HPV vaccination; similarity to multidose regimens was a conclusion, not a direct trial comparison. (LLM, conf=0.88)
Experimental — accuracy not yet measuredHigher valency vaccines are likely to be efficacious under a single-dose schedule.
“higher valency vaccines, which are also likely to be efficacious under a single-dose schedule.12”
From Evidence-based impact projections of single-dose human papillomavirus vaccination in India: a modelling study (2022) · cites this paper as [12]
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Human papillomaviruses: Knowns, mysteries, and unchartered territories
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HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine
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HPV vaccination programs in LMIC: is it time to optimize schedules and recommendations?
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Efficacy and Durability of Immune Response after Receipt of HPV Vaccines in People Living with HIV
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High-risk human papillomavirus genotyping in cervical cancers in Tanzania
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Global status of HPV vaccination two decades in: effective, safe and preventing cancer
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Acceptance of HPV vaccination in boys among mothers from selected churches in Accra, Ghana
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Evaluation of a single-dose HPV vaccine strategy for promoting vaccine, health, and gender equity
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Self-citationInforming HPV vaccine pricing for government-funded vaccination in mainland China: a modelling study
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Sexually transmitted human papillomavirus and related sequelae
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Area Socioeconomic Status, Vaccination Access, and Female Human Papillomavirus Vaccination
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de Carvalho, T. M., Man, I., Georges, D., Saraswati, L. R., Bhandari, P., Kataria, I., Siddiqui, M., Muwonge, R., Lucas, E., Sankaranarayanan, R., et al. (2023) · BMJ Global Health · doi:10.1136/bmjgh-2023-012580 · Cited by 12 · see citing works
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Unveiling the Role of Human Papillomavirus in Urogenital Carcinogenesis a Comprehensive Review
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Assessment of Human Papillomavirus Vaccination in Primary Care Among Swiss University Students
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Self-citationCurrent management of cervical cancer in women living with HIV
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Unraveling Immunological Dynamics: HPV Infection in Women—Insights from Pregnancy
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Effectiveness of HPV vaccination in reducing infection among young Brazilian women
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Development of a human papillomavirus (HPV) multiplex immunoassay to profile HPV antibodies
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Treatment of Cervical Precancers is the Major Remaining Challenge in Cervical Screening Research
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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
- Barnabas, Ruanne V.
- Brown, Elizabeth R.
- Onono, Maricianah A.
- Bukusi, Elizabeth A.
- Winer, Rachel L.
- Galloway, Denise A.
- Pinder, Leeya F.
- Donnell, Deborah
- Congo, Ouma
- Oluoch, Lynda
- Heller, Kate B.
- Leingang, Hannah
- Morrison, Susan
- Cherne, Stephen
- Schaafsma, Torin T.
- McClelland, R. Scott
- Celum, Connie
- Baeten, Jared M.
- Mugo, Nelly
- Venue
- NEJM Evidence
- Publisher
- Massachusetts Medical Society
- Published
- 2022-04-26
- Volume
- 1
- Issue
- 5
- Pages
- EVIDoa2100056-EVIDoa2100056
- ISSN
- 2766-5526 (ISSN-L)
- PMC
- PMC9172784
- OpenAlex
- W4223574449
- Cited by
- 223
- References
- 26
- Citations by year
- 2026: 49 · 2025: 48 · 2024: 54 · 2023: 52 · 2022: 19 · 2021: 1
- FWCI
- 31.22
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- 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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