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 (GESIDA10017)

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

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)

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Biological: HPV9v

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Madrid, Spain
    • Hospital La Paz
  • Madrid, Spain
    • Hospital Fundación Jiménez Díaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Men infected by HIV who have sex with men	Biological: HPV9v; Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24; Other Names: Gardasil9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)	The low CD4 / CD8 ratio has been associated with immunosenescence in the serological response, such as worse immunogenicity and worse response to vaccines	From basal until week 96
Number and type of metabolites derived from the microbiota of patients	Detect biomarkers derived from microbiota and their relationship with the vaccine response	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	Adverse events	From basal until week 96
The proportion of subjects with a severe adverse experience	Adverse events	From basal until week 96
The proportion of subjects with an adverse experience leading to disruption	Adverse events	From basal until week 96
The proportion of subjects with an adverse experience related to medication	Adverse events	From basal until week 96
The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period	Adverse events	From basal until week 96

Collaborators and Investigators

• Sponsor: Fundacion SEIMC-GESIDA
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): July 14, 2021

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: GESIDA10017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No