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

Autor:	Barnabas RV; Department of Global Health, University of Washington, Seattle, USA.; Division of Allergy and Infectious Diseases, University of Washington, Seattle, USA.; Department of Epidemiology, University of Washington, Seattle, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA.; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA., Brown ER; Department of Biostatistics, University of Washington, Seattle, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA.; Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, USA., Onono MA; Center for Microbiology Research, Kenya Medical Research Institute, Kenya., Bukusi EA; Department of Global Health, University of Washington, Seattle, USA.; Department of Obstetrics and Gynecology, University of Washington, Seattle, USA.; Center for Microbiology Research, Kenya Medical Research Institute, Kenya., Njoroge B; Center for Clinical Research, Kenya Medical Research Institute, Kenya., Winer RL; Department of Epidemiology, University of Washington, Seattle, USA., Galloway DA; Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, USA., Pinder LF; Department of Obstetrics and Gynecology, University of Washington, Seattle, USA.; Human Biology Division, Fred Hutchinson Cancer Research Center, Seattle, USA., Donnell D; Department of Global Health, University of Washington, Seattle, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA., Wakhungu I; Center for Microbiology Research, Kenya Medical Research Institute, Kenya., Congo O; Center for Clinical Research, Kenya Medical Research Institute, Kenya., Biwott C; Center for Clinical Research, Kenya Medical Research Institute, Kenya., Kimanthi S; Center for Clinical Research, Kenya Medical Research Institute, Kenya., Oluoch L; Center for Clinical Research, Kenya Medical Research Institute, Kenya., Heller KB; Department of Global Health, University of Washington, Seattle, USA., Leingang H; Department of Global Health, University of Washington, Seattle, USA., Morrison S; Department of Global Health, University of Washington, Seattle, USA., Rechkina E; Department of Global Health, University of Washington, Seattle, USA., Cherne S; Department of Pathology, University of Washington, Seattle, USA., Schaafsma TT; Department of Global Health, University of Washington, Seattle, USA., McClelland RS; Department of Global Health, University of Washington, Seattle, USA.; Division of Allergy and Infectious Diseases, University of Washington, Seattle, USA.; Department of Epidemiology, University of Washington, Seattle, USA., Celum C; Department of Global Health, University of Washington, Seattle, USA.; Division of Allergy and Infectious Diseases, University of Washington, Seattle, USA.; Department of Epidemiology, University of Washington, Seattle, USA., Baeten JM; Department of Global Health, University of Washington, Seattle, USA.; Division of Allergy and Infectious Diseases, University of Washington, Seattle, USA.; Department of Epidemiology, University of Washington, Seattle, USA.; Gilead Sciences, Foster City, CA, USA., Mugo N; Department of Global Health, University of Washington, Seattle, USA.; Center for Clinical Research, Kenya Medical Research Institute, Kenya.
Jazyk:	angličtina
Zdroj:	NEJM evidence [NEJM Evid] 2022 Jun; Vol. 1 (5), pp. EVIDoa2100056. Date of Electronic Publication: 2022 Apr 11.
DOI:	10.1056/EVIDoa2100056
Abstrakt:	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.) (Copyright: © 2022 Author(s), Massachusetts Medical Society. All rights reserved.)
Databáze:	MEDLINE
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