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

Abstract

Background:

Single-dose HPV vaccination, if efficacious, would be tremendously advantageous; simplifying implementation and decreasing costs.

Methods:

We performed a randomized, multi-center, double-blind, controlled trial of single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) or bivalent (HPV 16/18) HPV vaccination compared to meningococcal vaccination among Kenyan women aged 15-20 years. Enrollment and six monthly cervical swabs and a month three vaginal swab were tested for HPV DNA. Enrollment sera were tested for HPV antibodies. The modified intent-to-treat (mITT) cohort comprised participants who tested HPV antibody negative at enrollment and HPV DNA negative at enrollment and month three. The primary outcome was incident persistent vaccine-type HPV infection by month 18.

Results:

Between December 2018 and June 2021, 2,275 women were randomly assigned and followed; 758 received the nonavalent HPV vaccine, 760 the bivalent HPV vaccine, and 757 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%CI 81.7-99.7%, p=<0.0001), and bivalent VE was 97.5% (95%CI 81.6-99.7%, 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 68.5-96.1%, p<0.0001). The rate of SAEs was 4.5-5.2% by group.

Conclusions:

Over the 18 month time-frame we studied, single-dose bivalent and nonavalent HPV vaccines were each highly effective in preventing incident persistent oncogenic HPV infection, similar to multidose regimens.

• Authors: Ruanne V Barnabas, Elizabeth R Brown, Maricianah A Onono, Elizabeth A Bukusi, Betty Njoroge, Rachel L Winer, Denise A Galloway, Leeya F Pinder, Deborah Donnell, Imelda Wakhungu, Ouma Congo, Charlene Biwott, Syovata Kimanthi, Linda Oluoch, Kate B Heller, Hannah Leingang, Susan Morrison, Elena Rechkina, Stephen Cherne, Torin T Schaafsma, R Scott McClelland, Connie Celum, Jared M Baeten, Nelly Mugo
• Journal: NEJM evidence (NEJM Evid) Vol. 1 Issue 5 Pg. EVIDoa2100056 (Jun 2022) ISSN: 2766-5526 [Electronic] United States
• PMID: 35693874 (Publication Type: Journal Article)
• Copyright: Copyright: © 2022 Author(s), Massachusetts Medical Society. All rights reserved.