KEN SHE
KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study
N = 2,275NCT03675256
- Population
- Women aged 15 to 20 years in Kenya; 2275 randomly assigned between December 2018 and June 2021.
- Design
- Randomised, multicentre, double-blind, controlled trial of single-dose nonavalent or bivalent HPV vaccination compared with meningococcal vaccination in Kenyan women. Enrolment and 6-monthly cervical swabs, and a month 3 vaginal swab, were tested for HPV DNA; the modified intention-to-treat (mITT) cohort comprised participants HPV antibody-negative at enrolment and HPV DNA-negative at enrolment and month 3. The primary outcome was incident persistent vaccine-type HPV infection (by month 18 in the first report, through 3 years in the follow-up report).
- Primary endpoint
- Persistent HPV infection
- Arms
- Single-dose bivalent HPV vaccine (experimental, n = 760): One dose of bivalent HPV vaccine (HPV 16/18)
- Single-dose nonavalent HPV vaccine (experimental, n = 758): One dose of nonavalent HPV vaccine
- Meningococcal vaccine (control, n = 757): Meningococcal vaccine (control)
- People
- Barnabas RV, senior author Mugo N