KEN SHE Study on HPV-vaccine Efficacy
Study enrollment is complete and the primary results are published in NEJM Evidence.

The KENya Single-dose HPV-vaccine Efficacy (KEN SHE) Study is a clinical trial that will investigate if one dose of HPV vaccine is effective in preventing HPV infection in adolescents aged 15-20 years old. Currently, when people are vaccinated for HPV they receive multiple doses (multiple shots). A single dose of the HPV vaccine has not been fully studied before, but people who have received one dose seem to be fully protected from HPV infection.

The study will enroll 2,250 young women, aged 15-20 years, and be conducted at three sites in Kenya: 1) NorthEast of Nairobi, 2) Thika, a town in Kiambu County, and 3) Kisumu, in western Kenya. This study is conducted by Kenya Medical Research Institute (KEMRI) at the 3 Kenya sites and the University of Washington, Seattle, USA.

Two commercial, FDA-approved HPV vaccines will be used in this study – Cervarix & Gardasil 9. Both HPV vaccines are licensed products with extensive safety data. Adverse events related to HPV vaccines are rare. Enrollment is anticipated to take 12 months, with 36 or 37 months of follow-up for each participant.