Reducing HPV‑16/18 infectivity and transmission after Gardasil‑9 vaccination in HPV‑positive women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, open‑label Phase 4 trial giving a 3‑dose regimen of the 9‑valent HPV vaccine (Gardasil‑9) to women positive for HPV‑16 and/or HPV‑18 to measure changes in viral infectivity in cervical, oral, and anal samples. The protocol tests the hypothesis that vaccine‑induced, type‑specific antibodies reach infected mucosa and neutralize newly produced viral particles, reducing infective capacity and transmission risk. Investigators will also measure antibody levels for all nine vaccine‑covered HPV types before and after vaccination and correlate those levels with changes in infectivity. Participants are women ≥18 recently diagnosed (within 10 months) with HPV‑16 and/or HPV‑18 and are enrolled at a single center in Catalonia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gynaecology Unit, Bellvitge University Hospital (HUB)
  L'Hospitalet de Llobregat, Catalonia, Spain Recruiting

Study contacts

• Principal investigator: Miquel Àngel Pavón Ribas, PhD — Cancer Epidemiology Research Program (PREC), Catalan Institute of Oncology (ICO-Hospitalet)/Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain.
• Study coordinator: Miquel Àngel Pavón Ribas, PhD
• Email: mpavon@iconcologia.net
• Phone: +34932607123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.