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

NCT03626467 | Completed Phase 4

• 1 other identifier: GESIDA10017
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

Brief 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)

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

  From basal until week 96

Secondary Outcomes (8)

• Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)

  From basal until week 96

• Number and type of metabolites derived from the microbiota of patients

  From basal until week 96

• Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV

  Basal, week 28 and week 96

• The proportion of subjects experiencing adverse events

  From basal until week 96

• The proportion of subjects with a severe adverse experience

  From basal until week 96

Study Arms (1)

Arm 1

EXPERIMENTAL

Men infected by HIV who have sex with men

Biological: HPV9v

Interventions

HPV9v BIOLOGICAL

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

Also known as: Gardasil9

Arm 1

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previous history of anal cancer.
• Have previously received any vaccine against HPV.

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Fundación Jimenez Díaz

Madrid, Spain

Location

Hospital La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A phase IV, open-label and single-arm clinical trial

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 13, 2018
• Study Start: October 15, 2018
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)