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The KEN SHE Study on HPV-vaccine Efficacy

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ClinicalTrials.gov Identifier: NCT03675256
Recruitment Status : Enrolling by invitation
First Posted : September 18, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Kenya Medical Research Institute
Information provided by (Responsible Party):
Ruanne Barnabas, University of Washington

Brief Summary:

Study Description

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 15 clinic visits over a period of 37 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.


Condition or disease Intervention/treatment Phase
Papillomavirus Infections Biological: immediate Gardasil 9, delayed MenVeo vaccine Biological: immediate MenVeo vaccine, delayed Gardasil 9 Biological: immediate Cervarix, delayed MenVeo vaccine Phase 4

Detailed Description:

Cervical cancer is the leading cause of new cancer cases among women in Africa. Preliminary evidence suggests a single-dose of the HPV vaccine would be over 95% effective in preventing vaccine type-specific HIV infection, supporting HPV vaccination as a scaleable intervention for cervical cancer prevention. The overall aim of the study is to provide timely results of both single-dose HPV vaccine efficacy and estimates of the cost, cost-effectiveness, and budget impact for dissemination and translation to policy. Several HPV vaccines are available. The KEN SHE Study will determine the efficacy of two HPV vaccines: bivalent and nonavalent vaccines.

At the start of the study, young women will be randomly sorted into three arms. In arm 1, the women will receive the bivalent HPV vaccine. In arm 2, the women will receive the nonavalent HPV vaccine. And in arm 3, the women will receive a meningococcal vaccine. At the end of the study, those in arms 1 and 2 will receive the meningococcal vaccine, while those in arm 3 will receive either the bivalent or nonavalent HPV vaccine. The three-arm study structure makes it possible to compare the women who received an HPV vaccine to those who did not receive an HPV vaccine during the study.

The principal results of the study will demonstrate whether the single-dose HPV vaccine strategy prevents incident persistent HPV vaccine type specific infection among young women, by comparing the rate of new HPV infections among women who receive the vaccine immediately to those receiving delayed vaccination. Further, among the women who receive immediate HPV vaccine, investigators will estimate the durability of the bivalent and nonavalent HPV vaccines by measuring the antibody response and cumulative incidence of persistent cervical HPV over the duration of follow-up. Specifically, investigators will compare the incidence of high-risk vaccine HPV types overall and the distribution of HPV types by study arm. Investigators will assess the immunologic response to single-dose HPV vaccination, specifically regarding long lasting B cell responses to support the durability of the single-dose vaccination approach. Data on the magnitude of the antibody response at months 1 and 24 will support immunobridging analyses to young girls and adolescents. The 24 month antibody result will be used to assess durability of the response and will be directly comparable to other studies of the single-dose HPV vaccine which are uniformly using the month 24 antibody result as the primary outcome. Costing analyses will assess the resources required for scale-up of single-dose HPV vaccination.

Enrollment is anticipated to take 12 months, with 37 months of follow-up for each participant. A formal interim analysis will be conducted after 18 months of follow-up to provide early evidence on single-dose HPV vaccine efficacy. The endpoint-driven trial design among women at risk of HPV acquisition will provide interim results after 18 months of follow-up, and, with the extended follow-up, evidence on durability over three years. The study duration is 60 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: At the start of our study, young women will be randomly sorted into three arms. In arm 1, the women will receive the bivalent HPV vaccine. In arm 2, the women will receive the nonavalent HPV vaccine. And in arm 3, the women will receive a meningococcal vaccine. At the end of the study, those in arms 1 and 2 will receive the meningococcal vaccine, while those in arm 3 will receive either the bivalent or nonavalent HPV vaccine. The three arm study structure makes it possible to compare the women who received an HPV vaccine to those who did not receive an HPV vaccine during the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study is blinded. The pharmacists, unblinded data manager, and unblinded statistician are the only ones who will know treatment assignment.
Primary Purpose: Prevention
Official Title: KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Arm 1
immediate Cervarix, delayed MenVeo vaccine
Biological: immediate Cervarix, delayed MenVeo vaccine
Intervention is immediate administration of bivalent HPV vaccine and delayed MenVeo vaccine

Experimental: Arm 2
immediate Gardasil 9, delayed MenVeo vaccine
Biological: immediate Gardasil 9, delayed MenVeo vaccine
Intervention is immediate administration of 9-valent HPV vaccine and delayed MenVeo vaccine

Active Comparator: Arm 3
immediate MenVeo, delayed Gardasil 9 vaccine
Biological: immediate MenVeo vaccine, delayed Gardasil 9
Intervention is immediate administration of MenVeo vaccine and delayed administration of Gardasil 9




Primary Outcome Measures :
  1. Persistent HPV 16/18 infection across arms [ Time Frame: Analysis at month 36 ]
    Incident persistent HPV 16/18 infection across arms

  2. Persistent HPV 16/18/21/33/45/52/58 infection across arms [ Time Frame: Analysis at month 36 ]
    Incident persistent HPV 16/18/21/33/45/52/58 infection across the nonavalent and delayed HPV vaccine arms

  3. Non-inferiority of vaccine response in girls aged 15-20 compared to girls age 9-14 [ Time Frame: Analysis at month 36 ]
    Antibody response after single-dose bivalent or nonavalent vaccination in 15-20 year old adolescents compared to 9-14 year old girls in the DoRIS study


Secondary Outcome Measures :
  1. Cost of single-dose HPV vaccination [ Time Frame: Analysis at month 36 ]
    Cost of single-dose HPV vaccination to support implementation strategies for single-dose HPV vaccination following World Health Organization recommendation in high cervical cancer burden settings.

  2. immune memory following single-dose HPV vaccination [ Time Frame: Analysis at month 37 ]
    B-cell marker levels following single-dose bivalent and nonavalent vaccination.

  3. Cost-effectiveness of single-dose HPV vaccination [ Time Frame: Analysis at month 36 ]
    Cost-effectiveness of single-dose HPV vaccination to support implementation strategies for single-dose HPV vaccination following World Health Organization recommendation in high cervical cancer burden settings.

  4. Budget impact of single-dose HPV vaccination [ Time Frame: Analysis at month 36 ]
    Budget impact of single-dose HPV vaccination to support implementation strategies for single-dose HPV vaccination following World Health Organization recommendation in high cervical cancer burden settings.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born female
  • Age 15 to 20 years
  • HIV-negative
  • No history of HPV vaccination
  • Sexually active: history of 1-5 lifetime partners
  • Resident within study area without plans to move away in the next 37 months

Exclusion Criteria:

  • Allergies to vaccine components or latex,
  • Pregnancy
  • Hysterectomy
  • Autoimmune, degenerative, and genetic diseases
  • Investigator discretion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675256


Locations
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Kenya
Kargeno Research and Policy Hub
Kisumu, Nyanza, Kenya
Sponsors and Collaborators
University of Washington
Bill and Melinda Gates Foundation
Kenya Medical Research Institute
Investigators
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Principal Investigator: Ruanne Barnabas, MBChB, DPhil University of Washington
Principal Investigator: Nelly Mugo, MBChB, MPH Kenya Medical Research Institute

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Responsible Party: Ruanne Barnabas, Associate Professor, School of Medicine: Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT03675256     History of Changes
Other Study ID Numbers: STUDY00004913
OPP1188693 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs