Papillomavirus InfectionsPhase 4NCT03675256
The KEN SHE Study on HPV-vaccine Efficacy
A Phase 4 study testing immediate Gardasil 9, delayed MenVeo vaccine, immediate MenVeo vaccine, delayed Gardasil 9 and immediate Cervarix, delayed MenVeo vaccine in people with Papillomavirus Infections, run by Massachusetts General Hospital at 3 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- immediate Gardasil 9, delayed MenVeo vaccine, immediate MenVeo vaccine, delayed Gardasil 9 and immediate Cervarix, delayed MenVeo vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,275 participants
- Where
- 3 sitesKenya
- Study dates
- 19 Dec 2018to 15 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Allergies to vaccine components or latex,
- Pregnancy
- Hysterectomy
- Autoimmune, degenerative, and genetic diseases
- Investigator discretion
Trial locations and contacts
3 sites in 1 country.
Kenya3 sites
Kargeno Research and Policy Hub
Kisumu, Nyanza
Center for Clinical Research
Nairobi
Partners in Health, Research and Development
Thika, Kiambu County
About this study
Official title: KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study
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.
Read the detailed description
Cervical cancer is the leading cause of new cancer cases among women in Africa. Preliminary evidence suggested 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 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
- Papillomavirus Infections
- Being tested
- immediate Gardasil 9, delayed MenVeo vaccine, immediate MenVeo vaccine, delayed Gardasil 9, immediate Cervarix, delayed MenVeo vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate Gardasil 9, delayed MenVeo vaccineBiological
Intervention is immediate administration of 9-valent HPV vaccine and delayed MenVeo vaccine
immediate MenVeo vaccine, delayed Gardasil 9Biological
Intervention is immediate administration of MenVeo vaccine and delayed administration of Gardasil 9
immediate Cervarix, delayed MenVeo vaccineBiological
Intervention is immediate administration of bivalent HPV vaccine and delayed MenVeo vaccine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | immediate Cervarix, delayed MenVeo vaccine Receives: Biological: immediate Cervarix, delayed MenVeo vaccine |
| Arm 2 | Experimental | immediate Gardasil 9, delayed MenVeo vaccine Receives: Biological: immediate Gardasil 9, delayed MenVeo vaccine |
| Arm 3 | Active comparator | immediate MenVeo, delayed Gardasil 9 vaccine Receives: Biological: immediate MenVeo vaccine, delayed Gardasil 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
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
Measured: Secondary analysis at 24 months after enrollment and 18 months post crossover vaccination
Cost of single-dose HPV vaccination
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.
Measured: Secondary analysis at 18 months post crossover vaccination
Cost-effectiveness of single-dose HPV vaccination
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.
Measured: Secondary analysis at 18 months post crossover vaccination
Budget impact of single-dose HPV vaccination
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.
Measured: Secondary analysis at 18 months post crossover vaccination
Immune memory following single-dose HPV vaccination
B-cell marker levels following single-dose bivalent and nonavalent vaccination.
Measured: Secondary analysis at 19 months post crossover vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start19 Dec 2018
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Kenya Medical Research Institute
- Responsible party
- Principal investigator, Ruanne Barnabas, MBChB, MSc, DPhil., Massachusetts General Hospital
- Investigators
- Ruanne Barnabas, MBChB, DPhil, Principal investigator, Massachusetts General HospitalNelly Mugo, MBChB, MPH, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675256
- Sponsor's protocol ID
- 2022P001178
- Other IDs
- OPP1188693
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2018
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38049621Barnabas 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.
PubMed 35693874Barnabas 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.
PubMed 34579786Teppler 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.
PubMed 33857679Kreimer 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.
PubMed 32078808
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study
- ClinicalTrials.gov ID
- NCT03675256
- Acronym / sponsor ID
- 2022P001178
- Conditions
- Papillomavirus Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,275 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Kenya Medical Research Institute
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cervical cancer is the leading cause of new cancer cases among women in Africa. Preliminary evidence suggested 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: immediate Cervarix, delayed MenVeo vaccineimmediate Cervarix, delayed MenVeo vaccine |
| Arm 2 | Experimental | Biological: immediate Gardasil 9, delayed MenVeo vaccineimmediate Gardasil 9, delayed MenVeo vaccine |
| Arm 3 | Active comparator | Biological: immediate MenVeo vaccine, delayed Gardasil 9immediate MenVeo, delayed Gardasil 9 vaccine |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Born female
- Age 15 to 20 years
- HIV-negative
- No history of HPV vaccination
- Sexually active: history of 1-5 lifetime partners
Key exclusion criteria (5 listed)
- Allergies to vaccine components or latex,
- Pregnancy
- Hysterectomy
- Autoimmune, degenerative, and genetic diseases
- Investigator discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate Gardasil 9, delayed MenVeo vaccineIntervention is immediate administration of 9-valent HPV vaccine and delayed MenVeo vaccine | Biological | Arm 2 |
| immediate MenVeo vaccine, delayed Gardasil 9Intervention is immediate administration of MenVeo vaccine and delayed administration of Gardasil 9 | Biological | Arm 3 |
| immediate Cervarix, delayed MenVeo vaccineIntervention is immediate administration of bivalent HPV vaccine and delayed MenVeo vaccine | Biological | Arm 1 |
Primary outcome
Persistent HPV 16/18 infection across arms
Time frame: Primary analysis at month 18
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
Persistent HPV 16/18/21/33/45/52/58 infection across arms
Time frame: Primary analysis at month 18
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
Durability of HPV vaccine efficacy using blinded crossover vaccination design
Time frame: Primary analysis 18 months after crossover vaccination
Incident persistent HPV 16/18/21/33/45/52/58 infection will be compared between the early and late vaccine efficacy periods
5 secondary outcomes
Non-inferiority of vaccine response in girls aged 15-20 compared to girls age 9-14
Time frame: Secondary analysis at 24 months after enrollment and 18 months post crossover vaccination
Cost of single-dose HPV vaccination
Time frame: Secondary analysis at 18 months post crossover vaccination
Cost-effectiveness of single-dose HPV vaccination
Time frame: Secondary analysis at 18 months post crossover vaccination
Budget impact of single-dose HPV vaccination
Time frame: Secondary analysis at 18 months post crossover vaccination
Immune memory following single-dose HPV vaccination
Time frame: Secondary analysis at 19 months post crossover vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 38049621Barnabas 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.
- Derived from this study: PubMed 35693874Barnabas 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.
- Derived from this study: PubMed 34579786Barnabas 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.
- Derived from this study: PubMed 33857679Teppler 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.
- Derived from this study: PubMed 32078808Kreimer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruanne Barnabas, MBChB, DPhil principal investigator
Massachusetts General Hospital
Nelly Mugo, MBChB, MPH principal investigator
Kenya Medical Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing immediate Gardasil 9, delayed MenVeo vaccine, immediate MenVeo vaccine, delayed Gardasil 9 and immediate Cervarix, delayed MenVeo vaccine in people with Papillomavirus Infections, run by Massachusetts General Hospital at 3 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent HPV 16/18 infection across arms (time frame: Primary analysis at month 18). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03675256, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.