Can the HPV vaccine stop the virus in its tracks? new study aims to find out
NCT ID NCT05334706
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving the 9vHPV (Gardasil-9) vaccine to women who already have HPV16 or 18 can reduce the virus's ability to infect others. Researchers will measure viral activity in cervical, anal, and oral samples before and after vaccination. The goal is to see if the vaccine's antibodies can neutralize the virus at the site of infection, potentially lowering transmission to partners.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women. * Aged 18 years or older for RIFT-HPV Cohort 1 and 2, attending a routine cervical cancer screening visit or gynaecological visit. * Positive for HPV16, 18 or double-positive for 16 and 18 and negative for the rest of high-risk HPV types in a cervical sample. * Recently diagnosed for their HPV-positivity (within the last 10 months). * Meet one of the following criteria: have no apparent cervical lesion (Cohort 1). have a CIN1/2 lesion which is eligible for conservative treatment (cohort 1). have HPV 16 and/or HPV 18 positive anal test with non-apparent anal lesions or with anal lesions eligible for conservative treatment (Cohort 2). have HPV 16 and/or HPV 18 positive cervical test with vulvar premalignant lesion or condylomas, associated to HPV infection (Cohort 2). Exclusion Criteria: * Presence of any cervical lesion that requires clinical intervention within 7 months that could significantly affect cervical epithelia (and therefore, HPV viral production), such as cervical conization. * History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention. * History of allergy to any vaccine component, including aluminum, yeast, or BENZONASETM (nuclease, Nicomedia). * History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection of study vaccine. * History of splenectomy. * History of ano-genital cancer or HPV-related head and neck cancer. * Pregnancy at the time of signing informed consent or planning to become pregnant within the full duration of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gynaecology Unit, Bellvitge University Hospital (HUB)
RECRUITINGL'Hospitalet de Llobregat, Catalonia, 08907, Spain
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