Condition: Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III) · Human Papillomavirus (HPV) Infections · High-risk HPV · Sponsor: Miquel Angel Pavon Ribas
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. 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 each of the 9vHPV-covered HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58), to distinguish an induced antibody production due to 9vHPV vaccination from a natural response to an HPV infection (when antibody production is expected to be lower). * To demonstrate viral infectivity reduction in HPV 16/18/16+18 after vaccination with 1-dose or 2-dose regimen of 9vHPV. Since antibody production after administration of 2 vaccine doses is not inferior to 3 doses, infectivity reduction is expected to be detected after 2 doses, and at least partially after one dose. The main endpoint of the study is the …
This description comes directly from the study's public registry record.
Miquel Àngel Pavón Ribas, PhD · +34932607123 · mpavon@iconcologia.net
Marta López Querol, PhD · 932607812 · mlopezq@idibell.cat
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| Gynaecology Unit, Bellvitge University Hospital (HUB) | L'Hospitalet de Llobregat, Catalonia, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05334706