NCT03626467

A Clinical Trial to Evaluate the Immunogenicity of the Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017

A Phase IV, Open-label, Multicenter and Single-arm on the Immunogenicity of Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Fundacion SEIMC-GESIDA · Academic / Other
• Sex: Male
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

Summary

Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men (MSM)

Detailed description

The investigators estimate that 166 participants will need to be included in the study to evaluate the immunogenicity of vaccine against human papillomavirus in men with HIV infection who have sex with men, by evaluating in two age groups and the seroconversion rate for each of the HPV genotypes included in the vaccine from baseline to month 7 and 24.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	HPV9v	Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24

Timeline

• Start date: 2018-10-15
• Primary completion: 2021-07-14
• Completion: 2021-07-14
• First posted: 2018-08-13
• Last updated: 2023-08-25

Locations

3 sites across 1 country: Spain