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

Fundacion SEIMC-GESIDA158 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

HIV Infections

Interventions

HPV9vBIOLOGICAL

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 36 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients able to give their written consent to participate in the study. (preferably in writing or, failing that, orally before independent witnesses of the research team) after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment. * Understand the purpose of the study and be available to perform the visits stipulated in the protocol. * Be ≥18 years and \<of 36 years. * Patient with chronic infection with HIV-1. * Viral HIV load \<50 copies / ml and CD4\> 200 cells / uL for at least the last six months. * Transgender men or women who have had insertive or receptive anal sex with other men Exclusion Criteria: * Previous history of anal cancer. * Have previously received any vaccine against HPV.

Locations (3)

Hospital Ramón y Cajal

Madrid, Spain

Hospital Fundación Jimenez Díaz

Madrid, Spain

Hospital La Paz

Madrid, Spain

Outcomes

Primary Outcomes

Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine

The HPV genotypes studied are: 6/11/16/18/31/33/45/52/58. The cut-off points to determine serological status 30, 16, 20, 24, 10, 8, 8, 8, and 8 units / mL for HPV genotypes 6, 11, 16, 18, 31, 33, 45, 52 , and 58, respectively