The KEN SHE Study on HPV-vaccine Efficacy

The KEN SHE Study aims to identify effective cervical cancer prevention strategies. Cervical cancer is caused by an infection with Human Papillomavirus, also called HPV. In Kenya, about 2,500 women die from this condition each year. The study is conducted by Kenya Medical Research Institute (KEMRI) sites, based in Kisumu, Thika and Nairobi and the University of Washington, Seattle, USA. The purpose of this study is to learn whether a single dose of the HPV vaccine prevents HPV infection among adolescents and young women. 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. The study will involve approximately 21 clinic visits over a period of 55 months. All visits will involve blood draws and many will involve pelvic swabs. Participants will receive an FDA-approved HPV vaccine and a meningococcal vaccine.

Sex

Female

Minimum age

15 Years

Maximum age

20 Years

Inclusion Criteria:

* Born female
* Age 15 to 20 years
* HIV-negative
* No history of HPV vaccination
* Sexually active: history of 1-5 lifetime partners
* Resident within study area without plans to move away in the next 37 months

Exclusion Criteria:

* Allergies to vaccine components or latex,
* Pregnancy
* Hysterectomy
* Autoimmune, degenerative, and genetic diseases
* Investigator discretion

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