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The KEN SHE Study on HPV-vaccine Efficacy

NCT03675256 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2275

Last updated 2023-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Papillomavirus Infections

Interventions

BIOLOGICAL

immediate Gardasil 9, delayed MenVeo vaccine

Intervention is immediate administration of 9-valent HPV vaccine and delayed MenVeo vaccine

BIOLOGICAL

immediate MenVeo vaccine, delayed Gardasil 9

Intervention is immediate administration of MenVeo vaccine and delayed administration of Gardasil 9

BIOLOGICAL

immediate Cervarix, delayed MenVeo vaccine

Intervention is immediate administration of bivalent HPV vaccine and delayed MenVeo vaccine

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Kenya Medical Research Institute

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ruanne Barnabas, MBChB, DPhil · Massachusetts General Hospital

  • Nelly Mugo, MBChB, MPH · Kenya Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2024-02-15
Completion
2024-02-15

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675256 on ClinicalTrials.gov