KEN SHE Study
Phase 4
- Conditions
- Cancer
- Registration Number
- PACTR202002647375231
- Lead Sponsor
- niversity of Wshington
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 2275
Inclusion Criteria
•Born female
•Age 15 to 20 years
•Sexually active: history of 1-5 lifetime partners
•Resident within study area without plans to move away in the next 37 months
Exclusion Criteria
•HIV positive rapid result
•History of HPV vaccination
•Allergies to vaccine components or latex,
•Pregnancy
•Hysterectomy
•Autoimmune, degenerative, and genetic diseases
•Investigator discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study endpoint is persistent vaccine type specific HPV infection at months 18 and 36. The quantitative antibody response will be documented at months 1 and 24 to support immunobridging analyses to girls and adolescents for the single-dose bivalent and nonavalent vaccines. Using the data on persistent infections and health economic models, we will assess the impact on cervical cancer incidence.
- Secondary Outcome Measures
Name Time Method The cost, cost-effectiveness and budget impact of single-dose bivalent and nonavalent HPV vaccine per dysplastic lesion and incident cervical cancer case prevented compared to the standard of care <br>Baseline HPV 16/18/31/33/45/52/58 DNA prevalence by age among young, sexually active women in Kenya<br>Baseline HPV 16/18/31/33/45/52/58 antibody prevalence by age among young, sexually active women in Kenya<br>Breadth, magnitude and established central memory of the immune response to a single-dose of the bivalent and nonavalent vaccines among women age 15-20 years in Kenya<br>Non-inferiority of the antibody GMTs at months 1 and 24 of young girls (9-14 years in the DoRIS Study) compared to the titers observed in the KEN-SHE Study among young women age 15-20 years<br>