NCT07303751Not yet recruitingPhase 2
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
HPV Vaccination and Infectivity Reduction in HPV-positive Women
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Diseases
- Cervical cancer
- NCT number
- NCT07303751
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 1 Feb 2026 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- They have been previously vaccinated against HPV;
- 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
Other illness
- 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 allergic to one of the vaccine components or to latex;
Other
- They are pregnant or planning to get pregnant in the next 12 months;
- They are less than three months post-partum or currently breastfeeding;
- The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 29 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kambia Research Centre Coordinator of this site? Confirm its status | Freetown | Sierra Leone | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.