Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
2275 participants
INTERVENTIONAL
2018-12-19
2024-02-15
Brief Summary
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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.
Detailed Description
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At the start of the study, young women were randomly sorted into three arms. In arm 1, the women received the bivalent HPV vaccine. In arm 2, the women received the nonavalent HPV vaccine. And in arm 3, the women received a meningococcal 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. A formal primary analysis was planned to be conducted after 18 months of follow-up to provide early evidence on single-dose HPV vaccine efficacy.
The principal results of the primary analysis conducted 18 months after enrollment were to 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. Single dose HPV vaccination was highly effective at the month 18 primary analysis timepoint. Thus, as recommended by the Data Saftey Monitoring Board, participants should receive a blinded crossover vaccination. Participants who received the HPV vaccine at enrollment will receive the meningococcal vaccine and participants who received the meningococcal vaccine at enrollment, will receive the HPV vaccine (i.e. crossover vaccination). Questions remain regarding the durability of single-dose HPV vaccine efficacy which may limit the uptake of single-dose HPV vaccination. To ensure that vaccine efficacy is durable, crossover vaccination and follow-up will be conducted using a blinded crossover study design. This design will allow comparison of the early and late vaccine efficacy to ensure that single-dose HPV vaccine clinical efficacy does not wane over time. Thus, the study will contribute data on both single-dose HPV vaccine efficacy and durability of the effect. A final analysis will be conducted with the conclusion of up to 55 months of follow-up; if waning protection is detected, participants will receive the World Health Organization recommended course of HPV vaccination.
With the introduction of the crossover vaccination, the primary study endpoint is now persistent vaccine type specific HPV infection at months 18 and 18 months after blinded crossover vaccination. 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. 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. Further, among the women who received immediate HPV vaccine, investigators will estimated 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. Costing analyses will assess the resources required for scale-up of single-dose HPV vaccination.
Enrollment took 12 months and there are 55 months of follow-up for each participant. The endpoint-driven trial design among women at risk of HPV acquisition will provide primary results after 18 months of follow-up, and, with the extended follow-up, evidence on durability over three years. The study duration is 78 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Arm 1
immediate Cervarix, delayed MenVeo vaccine
immediate Cervarix, delayed MenVeo vaccine
Intervention is immediate administration of bivalent HPV vaccine and delayed MenVeo vaccine
Arm 2
immediate Gardasil 9, delayed MenVeo vaccine
immediate Gardasil 9, delayed MenVeo vaccine
Intervention is immediate administration of 9-valent HPV vaccine and delayed MenVeo vaccine
Arm 3
immediate MenVeo, delayed Gardasil 9 vaccine
immediate MenVeo vaccine, delayed Gardasil 9
Intervention is immediate administration of MenVeo vaccine and delayed administration of Gardasil 9
Interventions
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immediate Gardasil 9, delayed MenVeo vaccine
Intervention is immediate administration of 9-valent HPV vaccine and delayed MenVeo vaccine
immediate MenVeo vaccine, delayed Gardasil 9
Intervention is immediate administration of MenVeo vaccine and delayed administration of Gardasil 9
immediate Cervarix, delayed MenVeo vaccine
Intervention is immediate administration of bivalent HPV vaccine and delayed MenVeo vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Hysterectomy
* Autoimmune, degenerative, and genetic diseases
* Investigator discretion
15 Years
20 Years
FEMALE
Yes
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Kenya Medical Research Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Ruanne Barnabas, MBChB, MSc, DPhil.
Principal Investigator
Principal Investigators
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Ruanne Barnabas, MBChB, DPhil
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Nelly Mugo, MBChB, MPH
Role: PRINCIPAL_INVESTIGATOR
Kenya Medical Research Institute
Locations
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Partners in Health, Research and Development
Thika, Kiambu County, Kenya
Kargeno Research and Policy Hub
Kisumu, Nyanza, Kenya
Center for Clinical Research
Nairobi, , Kenya
Countries
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References
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Barnabas RV, Brown ER, Onono MA, Bukusi EA, Njoroge B, Winer RL, Galloway DA, Pinder LF, Donnell D, N Wakhungu I, Biwott C, Kimanthi S, Heller KB, Kanjilal DG, Pacella D, Morrison S, A Rechkina E, L Cherne S, Schaafsma TT, McClelland RS, Celum C, Baeten JM, Mugo NR; KEN SHE Study Team. Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results. Nat Med. 2023 Dec;29(12):3224-3232. doi: 10.1038/s41591-023-02658-0. Epub 2023 Dec 4.
Barnabas RV, Brown ER, Onono MA, Bukusi EA, Njoroge B, Winer RL, Galloway DA, Pinder LF, Donnell D, Wakhungu I, Congo O, Biwott C, Kimanthi S, Oluoch L, Heller KB, Leingang H, Morrison S, Rechkina E, Cherne S, Schaafsma TT, McClelland RS, Celum C, Baeten JM, Mugo N. Efficacy of single-dose HPV vaccination among young African women. NEJM Evid. 2022 Jun;1(5):EVIDoa2100056. doi: 10.1056/EVIDoa2100056. Epub 2022 Apr 11.
Barnabas RV, Brown ER, Onono M, Bukusi EA, Njoroge B, Winer RL, Donnell D, Galloway D, Cherne S, Heller K, Leingang H, Morrison S, Rechkina E, McClelland RS, Baeten JM, Celum C, Mugo N; KEN SHE Study Team. Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial. Trials. 2021 Sep 27;22(1):661. doi: 10.1186/s13063-021-05608-8.
Teppler H, Bautista O; Thomas Group; Flores S, McCauley J, Luxembourg A. Design of a Phase III immunogenicity and safety study evaluating two-dose regimens of 9-valent human papillomavirus (9vHPV) vaccine with extended dosing intervals. Contemp Clin Trials. 2021 Jun;105:106403. doi: 10.1016/j.cct.2021.106403. Epub 2021 Apr 12.
Kreimer AR, Cernuschi T, Rees H, Saslow D, Porras C, Schiller J. Prioritisation of the human papillomavirus vaccine in a time of constrained supply. Lancet Child Adolesc Health. 2020 May;4(5):349-351. doi: 10.1016/S2352-4642(20)30038-9. Epub 2020 Feb 17. No abstract available.
Other Identifiers
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OPP1188693
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022P001178
Identifier Type: -
Identifier Source: org_study_id