Status:
UNKNOWN
A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)
Lead Sponsor:
Miquel Angel Pavon Ribas
Collaborating Sponsors:
Hospital del Mar
Catalan Institute of Health
Conditions:
Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III)
Human Papillomavirus (HPV) Infections
Eligibility:
FEMALE
27+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Women.
- Aged 35 or 27 years or older for RIFT-HPV Cohort 1 and 2 respectively, 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 24 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 multiple cervical, vulvar and/or anal lesions, and cervical lesions are eligible for conservative treatment (Cohort 2).
Exclusion
- 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.
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05334706
Start Date
September 13 2022
End Date
May 1 2024
Last Update
May 9 2023
Active Locations (1)
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1
Gynaecology Unit, Bellvitge University Hospital (HUB)
L'Hospitalet de Llobregat, Catalonia, Spain, 08907