Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002647375231 Date of Approval: 12/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title KEN SHE Study
Official scientific title Single-dose HPV catch-up vaccination efficacy: A blinded, randomized study of single-dose HPV vaccination among adolescent girls and young women in Kenya
Brief summary describing the background and objectives of the trial Introduction: Cervical cancer is the leading cause of new cancer cases among women in Kenya representing a substantial burden of disease for women. HPV infection is a necessary cause of cervical cancer and preliminary evidence suggests a single-dose of the HPV vaccine would provide efficacy in excess of 95%,1 supporting HPV vaccination as a scaleable intervention for cervical cancer prevention. An evidence gap exists on the efficacy and durability of single-dose HPV vaccine among young women in Africa. Objectives: The primary objective is to compare immediate, single-dose bivalent (HPV 16/18) and nonavalent (HPV 16/18/31/33/45/52/58/6/11) vaccination (and delayed meningococcal immunization) with delayed HPV vaccination (and immediate meningococcal immunization) among young women age 15-20 years. We will also conduct costing, budget impact, and cost-effectiveness analyses to provide evidence for decision makers
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 20/12/2018
Actual trial start date 20/12/2018
Anticipated date of last follow up 30/10/2026
Actual Last follow-up date 30/10/2026
Anticipated target sample size (number of participants) 2275
Actual target sample size (number of participants) 2275
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group cervarix Single dose 36-37 months single dose HPV vaccine 758
Experimental Group Gardasil 9 Single dose 36-37 months follow up HPV vaccine 759
Control Group Meningococcal Vaccine Single dose 36-37 months follow up Vaccination against meningococcal 758 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 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 • HIV positive rapid result • History of HPV vaccination • Allergies to vaccine components or latex, • Pregnancy • Hysterectomy • Autoimmune, degenerative, and genetic diseases • Investigator discretion Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 20 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/09/2018 KEMRI SCIENTIFIC AND ETHICS REVIEW UNIT
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. month 18 and month 36
Secondary Outcome 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 36-37 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kargeno Agoi Street Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation PO Box 23350 Seattle, WA 98102 Washington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Massachusetts General Hospital Boston, MA 02114-XXXX Boston United States of America Clinical Trials
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maricianah Onono maricianah@gmail.com +254732390992 19669
City Postal code Country Position/Affiliation
Kisumu 40123 Kenya Country Director
Role Name Email Phone Street address
Public Enquiries Maricianah Onono maricianah@gmail.com +254732390992 19669
City Postal code Country Position/Affiliation
Kisumu 40123 Kenya Country Director
Role Name Email Phone Street address
Scientific Enquiries Maricianah Onono maricianah@gmail.com +254732390992 19669
City Postal code Country Position/Affiliation
Kisumu 40123 Kenya Country Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol After 37 months follow up Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information