The KEN SHE Study on HPV-vaccine Efficacy

NCT03675256 | Unknown Phase 4 DMC

• 2 other identifiers: 2022P001178OPP1188693
• Study Type: interventional
• Target: 2,275
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (3)

• Persistent HPV 16/18 infection across arms

  Incident persistent HPV 16/18 infection across arms to measure HPV16/18 and HPV 16/18/31/33/45/52/58/6/11 vaccine efficacy

  Primary analysis at month 18

• Persistent HPV 16/18/21/33/45/52/58 infection across arms

  Incident persistent HPV 16/18/21/33/45/52/58 infection across the HPV 16/18/31/33/45/52/58/6/11 and immediate meningococcal (delayed HPV) vaccine arms to measure HPV 16/18/31/33/45/52/58/6/11 vaccine efficacy

  Primary analysis at month 18

• Durability of HPV vaccine efficacy using blinded crossover vaccination design

  Incident persistent HPV 16/18/21/33/45/52/58 infection will be compared between the early and late vaccine efficacy periods

  Primary analysis 18 months after crossover vaccination

Secondary Outcomes (5)

• Non-inferiority of vaccine response in girls aged 15-20 compared to girls age 9-14

  Secondary analysis at 24 months after enrollment and 18 months post crossover vaccination

• Cost of single-dose HPV vaccination

  Secondary analysis at 18 months post crossover vaccination

• Cost-effectiveness of single-dose HPV vaccination

  Secondary analysis at 18 months post crossover vaccination

• Budget impact of single-dose HPV vaccination

  Secondary analysis at 18 months post crossover vaccination

• Immune memory following single-dose HPV vaccination

  Secondary analysis at 19 months post crossover vaccination

Study Arms (3)

Arm 1

EXPERIMENTAL

immediate Cervarix, delayed MenVeo vaccine

Biological: immediate Cervarix, delayed MenVeo vaccine

Arm 2

EXPERIMENTAL

immediate Gardasil 9, delayed MenVeo vaccine

Biological: immediate Gardasil 9, delayed MenVeo vaccine

Arm 3

ACTIVE COMPARATOR

immediate MenVeo, delayed Gardasil 9 vaccine

Biological: immediate MenVeo vaccine, delayed Gardasil 9

Interventions

immediate Gardasil 9, delayed MenVeo vaccine BIOLOGICAL

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

Arm 2

immediate MenVeo vaccine, delayed Gardasil 9 BIOLOGICAL

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

Arm 3

immediate Cervarix, delayed MenVeo vaccine BIOLOGICAL

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

Arm 1

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bill and Melinda Gates Foundation: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (3)

Partners in Health, Research and Development

Thika, Kiambu County, Kenya

Location

Kargeno Research and Policy Hub

Kisumu, Nyanza, Kenya

Location

Center for Clinical Research

Nairobi, Kenya

Location

Related Publications (5)

• 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.

  PMID: 38049621 DERIVED

• 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.

  PMID: 35693874 DERIVED

• 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.

  PMID: 34579786 DERIVED

• 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.

  PMID: 33857679 DERIVED

• 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.

  PMID: 32078808 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruanne Barnabas, MBChB, DPhil

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Nelly Mugo, MBChB, MPH

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is blinded. The pharmacists, unblinded data manager, and unblinded statistician are the only ones who will know treatment assignment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 crossover vaccine timepoint, 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.

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 18, 2018
• Study Start: December 19, 2018
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

KE (3)