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A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)

RecruitingPhase 4Ages 18 Years - anyFemaleMiquel Angel Pavon Ribas
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In plain words

What the trial is, and whether it could suit you

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-9โ„ข. 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. This objective rests upon the hypothesis that, since vaccination with 9vHPV triggers the production of type-specific HPV antibodies which are exudated to the cervical and other infected mucosae, these antibodies adhere to and neutralize newly produced HPV 16/18 viral particles also present in the mucosae, thus reducing HPV's infective capacity and transmission to sexual partners. Secondary objectives of the study are: * To determine HPV antibody levels before and after vaccination for ea

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Nonavalent HPV vaccine (9vHPV/Gardasil-9โ„ข).
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Where

1 site
Gynaecology Unit, Bellvitge University Hospital (HUB)
L'Hospitalet de Llobregat, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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