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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; N. Wakhungu, Imelda; Biwott, Charlene; Kimanthi, Syovata; Heller, Kate B.; Kanjilal, Diane G.; Pacella, Daniel; Morrison, Susan; A. Rechkina, Elena; L. Cherne, Stephen; Schaafsma, Torin T.; McClelland, R. Scott; Celum, Connie; Baeten, Jared M.; Mugo, Nelly R.; Dull, Peter; [...]

Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results

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  • Media type: E-Article
  • Title: Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results
  • Contributor: 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; N. Wakhungu, Imelda; Biwott, Charlene; Kimanthi, Syovata; Heller, Kate B.; Kanjilal, Diane G.; Pacella, Daniel; Morrison, Susan; A. Rechkina, Elena; L. Cherne, Stephen; Schaafsma, Torin T.; McClelland, R. Scott; Celum, Connie; Baeten, Jared M.; Mugo, Nelly R.; Dull, Peter; [...]
  • Published: Springer Science and Business Media LLC, 2023
  • Published in: Nature Medicine, 29 (2023) 12, Seite 3224-3232
  • Language: English
  • DOI: 10.1038/s41591-023-02658-0
  • ISSN: 1078-8956; 1546-170X
  • Origination:
  • Footnote:
  • Description: AbstractCervical 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.