Journal Article

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

Galloway, Denise A., Bukusi, Elizabeth A., A. Rechkina, Elena, Kimanthi, Syovata, Barnabas, Ruanne V., Pinder, Leeya F., L. Cherne, Stephen, Onono, Maricianah A., Winer, Rachel L., Baeten, Jared M., N. Wakhungu, Imelda, McClelland, R. Scott, Kanjilal, Diane G., Pacella, Daniel, Celum, Connie, Morrison, Susan, Mugo, Nelly R., Schaafsma, Torin T., Donnell, Deborah, Heller, Kate B., Brown, Elizabeth R., Njoroge, Betty, Biwott, Charlene

2023

Overview

Cervical 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 . In a prespecified 3-year analysis of the KEN SHE trial, single-dose HPV vaccination was shown to be well tolerated and provided durable protection against cervical HPV infection in Kenyan women aged 15–20 years.

• Publisher: Nature Publishing Group US,Nature Publishing Group
• Subject: 692/308/575 / 692/700/459/1748 / Biomedical and Life Sciences / Biomedicine / Cancer Research / Cervical cancer / Double-Blind Method / Durability / Female / Human papillomavirus / Human papillomavirus 16 / Human papillomavirus 18 / Humans / Immunization / Infections / Infectious Diseases / Kenya - epidemiology / Metabolic Diseases / Molecular Medicine / Neurosciences / Papillomaviridae / Papillomavirus Infections - prevention & control / Papillomavirus Vaccines - adverse effects / Persistent Infection / Uterine Cervical Neoplasms - prevention & control / Vaccination - methods / Vaccine efficacy / Vaccines