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

A Non-Randomized, Open-Label Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV16/18-Positive Women After Vaccination With 9vHPV, a Multivalent L1 Virus-like Particle Vaccine, Evaluated in Cervical, Anal and Oral Samples Obtained After One, Two, and Three Vaccine Doses (RIFT-HPV1/RIFT-HPV2)

This trial will try to see if three doses of Gardasil‑9 given to women with HPV‑16 and/or HPV‑18 reduce how infectious the virus is and lower the chance of passing it to partners.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut d'Investigació Biomèdica de Bellvitge (other)
• Locations: 1 site (L'Hospitalet de Llobregat, Catalonia)
• Trial ID: NCT05334706 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18 or older recently (within 10 months) diagnosed with cervical HPV‑16 and/or HPV‑18 who are either lesion‑free or have CIN1/2 or anal/vulvar lesions eligible for conservative management.

Not a fit: Women who need immediate clinical intervention for their cervical lesions, who carry other high‑risk HPV types, or whose infection is longstanding beyond the trial’s 10‑month window are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, vaccinating HPV‑positive women could lower viral infectivity and transmission, potentially reducing partner exposure and decreasing progression or spread of HPV‑related lesions.

How similar studies have performed: Immunologic studies and observational data show HPV vaccination raises type‑specific antibodies and can lower HPV detection, but using 9vHPV to directly reduce infectivity and transmission in HPV‑positive women is not yet proven in randomized clinical trials.

Eligibility criteria

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 this trial is running

L'Hospitalet de Llobregat, Catalonia

• 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

Conditions: Cervical Intraepithelial Neoplasia Grade I/ II/ III, Human Papillomavirus Infections, High-risk HPV, HPV-16/ 18, Cervical cancer, Squamous Intraepithelial Lesions of the Cervix, High/ Low Grade., Uterine Cervical Neoplasms, HPV DNA Tests