KEN SHE Study

Single-dose HPV catch-up vaccination efficacy: A blinded, randomized study of single-dose HPV vaccination among adolescent girls and young women in Kenya

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202002647375231

Enrollment

2275

Registered

2020-02-12

Start date

2018-12-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

cervarix

Gardasil 9

Meningococcal Vaccine

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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 Baseline HPV 16/18/31/33/45/52/58 DNA prevalence by age among young, sexually active women in Kenya Baseline HPV 16/18/31/33/45/52/58 antibody prevalence by age among young, sexually active women in Kenya 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 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	—

Measure

Time frame

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 Baseline HPV 16/18/31/33/45/52/58 DNA prevalence by age among young, sexually active women in Kenya Baseline HPV 16/18/31/33/45/52/58 antibody prevalence by age among young, sexually active women in Kenya 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 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

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Countries

Kenya

Contacts

Public ContactMaricianah Onono

Country Director

maricianah@gmail.com+254732390992

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026