Presenter of 3 Presentations
STATE OF THE SCIENCE ON HPV VACCINATION
ONE DOSE HPV VACCINATION OVERVIEW AND A FOCUS ON THE KENSHE DATA
A RANDOMIZED TRIAL OF SINGLE-DOSE HPV VACCINATION EFFICACY AMONG YOUNG WOMEN: FINAL EFFICACY RESULTS
Abstract
Introduction
Single-dose HPV 16/18 vaccination efficacy (VE) of 97.5% at month 18 is comparable to multi-dose regimens at months 24-36. Data on single-dose durability over several years are needed.
Methods
We conducted a randomized, multicenter, double-blind, controlled, cross-over trial to estimate the efficacy of single-dose HPV vaccination at three study sites in Kenya. Healthy, 15- to 20-year-old women were randomly assigned (1:1:1) to single-dose bivalent (HPV 16/18), nonavalent (HPV 16/18/31/33/45/52/58/6/11), or control (meningococcal) vaccination. The modified intent-to-treat (mITT) HPV 16/18 and HPV 16/18/31/33/45/52/58 cohorts included HPV naïve participants (i.e., participants who tested negative for vaccine type-specific HPV DNA at enrollment and month three and HPV antibody negative at enrollment). During follow-up, clinicians collected cervical swabs every six months, which were tested for HPV DNA for endpoints. The outcome was incident persistent vaccine type-specific HPV infection. We analyzed VE up to the cross-over study visit at month 36.
Results
Between December 2018 and November 2019, we recruited and randomly assigned 2,275 participants to receive bivalent (n=760), nonavalent (n=758), or control (n=757) vaccine. From enrollment to January 2023, 2,061/2,275 (90.7%) randomized participants provided at least five swabs for HPV DNA testing before cross-over vaccination. The median follow-up up to cross-over was 35 months. Seventy-five incident persistent infections were detected in the HPV 16/18 mITT cohort: two in the bivalent group, one in the nonavalent group, and 72 in the control group; nonavalent VE was 98.8% (95%CI 91.3-99.8%, p=<0.0001); bivalent VE was 97.5% (95%CI 90.0-99.4%, p=<0.0001). Eighty-nine persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: five in the nonavalent group and 84 in the control group; nonavalent VE was 95.5% (95%CI 89.0-98.2%, p<0.0001). The rate of SAEs was 7.8-9.5% by group; none were vaccine-related.
Conclusions
In a randomized trial among young women with HPV exposure, single-dose HPV vaccination was highly efficacious (>95%) over three years.