Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT05334706
Eligibility Criteria:
Inclusion Criteria:
* 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 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
27 Years
Study:
NCT05334706
Study Brief:
Protocol Section:
NCT05334706