Study Background

Cervical cancer is one of the most common types of cancers worldwide and is the leading cause of new cancer cases among women in Africa. In Kenya, about 2,500 women die from this condition each year. Cervical cancer is caused by an infection with Human papillomavirus, also called HPV, but there are highly effective and safe vaccines that can prevent HPV infections and, therefore, cervical cancer.

While Kenya has plans to roll out HPV vaccination for 9-10 year-old girls, and the Global Alliance for Vaccines and Immunization (GAVI) supports vaccination to age 14 years, a gap exists in prevention strategies for young women age 15-20 years. The primary challenge to vaccinating this age group is the cost associated with a 2-dose vaccine schedule. Reducing the vaccine dose to one could address this barrier.

Preliminary evidence from other studies conducted in Costa Rica and India suggest a single-dose of the HPV vaccine could be 95% effective in preventing lasting HPV infection. The results of this study will demonstrate whether the single-dose HPV vaccine would be effective in preventing lasting HPV infection among 15-20 year-old women in Kenya. Using a single dose will lower the cost of providing HPV vaccination (compared to two doses) and will make it possible for more women to receive the vaccination and be protected from cervical cancer.

 

Quick Facts About the Study

Title of Project: Single-dose HPV catch-up vaccination efficacy: A blinded, randomized study of singledose HPV vaccination among adolescent girls and young women in Kenya
Study Name: KENya Single-dose HPV vaccine Efficacy – The KEN SHE Study
Funding Agency: Bill and Melinda Gates Foundation (OPP1188693)
Sample Size: 2,250
Study Population: Adolescent girls and young women age 15-20 years old
Study Sites: 1) Nairobi, 2) Thika, and 3) Kisumu, Kenya
Follow-up Duration: 36 or 37 months from vaccination
Overall Study Duration: Dec 2018-Dec 2022 (Enrollment until end of Dec 2019)