Status:
ACTIVE_NOT_RECRUITING
Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women
Lead Sponsor:
University Hospital Virgen de las Nieves
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
HIV Infections
HPV Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
In adult HIV-positive patients, data on the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine have been reported with excellent results (13 14); also, the results of a clinical trial of...
Detailed Description
This is a phase IV (post-authorization study), open, single-arm trial of 9-valent human papillomavirus (9-HPV) vaccine in HIV-positive women. The recruitment and follow-up period will be 6 and 30 mont...
Eligibility Criteria
Inclusion
- HIV-positive women patients of ≥18 years of age who, at the time of study inclusion were not infected simultaneously by the 16, 18 genotypes of HPV in vagina and/or anus.
Exclusion
- WLHIV patients who had simultaneous anal infection with the 16, 18, 31, 33, 45, 52 y 58 genotypes. - WLHIV diagnosed in V0 of ASCC or anal HSIL.
- Active opportunist infection at the time of recruitment into the study.
- Cd4 count \< 200 cel/µL.
- History of allergy to aluminium and/or yeast extract excipient.
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04270773
Start Date
February 12 2020
End Date
December 30 2024
Last Update
July 10 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Virgen de Las Nieves
Granada, Andalusia, Spain, 18008