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ACTIVE NOT RECRUITING
NCT04270773
PHASE4

Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women

Sponsor: University Hospital Virgen de las Nieves

View on ClinicalTrials.gov

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 qHPV vaccine conducted in seropositive patients older than 36 years (WLHIV and MSM) have been published. Even now, there is not a trial about immunogenicity and safety of a 9-valent human papillomavirus vaccine in HIV-positive women; for this reason, the investigators plan to conduct this clinical trial. HYPOTHESYS: The administration of Nonavalent HPV vaccine (HPV-9) in adult women living with HIV will produce antibodies against nine genotypes of HPV, thus preventing the acquisition of new infections by those genotypes. Besides, this will prevent the cervical and anal dysplasia in these women.

Official title: Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2020-02-12

Completion Date

2024-12-30

Last Updated

2024-07-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Human Papillomavirus 9-valent Vaccine, Recombinant

Vaccine administrated

Locations (1)

Hospital Universitario Virgen de Las Nieves

Granada, Andalusia, Spain