Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccinat… (NCT07303751) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
Sierra Leone80 participantsStarted 2026-02-01
Plain-language summary
This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16/18/31/33/45/52 or 58 can decrease the infectivity of shed HPV viruses.
Our hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.
Who can participate
Age range
18 Years – 29 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Born female
* Aged between 18-29 years old;
* Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;
* Willing to participate in the study and have signed the informed consent form;
* In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);
* Willing to be tested for HIV;
* Are HIV negative at the screening visit;
* Not pregnant;
* Able to pass a Test of Understanding (TOU);
* Willing to provide cervical, urine and blood samples;
* Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;
* Have no visible suspicious cervical lesions on examination.
* Agree to a pregnancy test at screening and before any HPV vaccination.
Exclusion Criteria:
* They have been previously vaccinated against HPV;
* They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
* They are HIV positive or immunocompromised;
* They are pregnant or planning to get pregnant in the next 12 months;
* They are less than three months post-partum or currently breastfeeding;
* They are allergic to one of the vaccine components or to latex;
* They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose
* The nurse or clinician determining…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The difference in infective capacity of cervical HPV virions at 6 months, between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
Timeframe: 7 months
Trial details
NCT IDNCT07303751
SponsorInstitut d'Investigació Biomèdica de Bellvitge