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New treatment option for Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III)
Official title A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)
ClinicalTrials.gov ID: NCT05334706
What this study is testing
What is Nonavalent HPV vaccine (9vHPV/Gardasil-9™).?
Nonavalent HPV vaccine (9vHPV/Gardasil-9™). is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cervical intraepithelial neoplasia grade i/ ii/ iii (cin i/ii/iii).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a non-randomized, open label study to assess the reduction of Human Papillomavirus (HPV) infectivity and transmission in women positive for HPV16 and/or 18 in a cervical, oral and anal sample and vaccinated with 9vHPV/Gardasil-9™. The primary objective of the study is to demonstrate that vaccination with a 3-dose regimen of 9vHPV will reduce viral infectivity in HPV 16/18/16+18-positive women.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- Presence of any cervical lesion that requires clinical intervention within 7 months that could significantly affect cervical epithelia (and...
- History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical...
- 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- L'Hospitalet de Llobregat, Catalonia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include L'Hospitalet de Llobregat, Catalonia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.