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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)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
HPV9v
Sponsored by
Fundacion SEIMC-GESIDA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 36 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Ramón y Cajal
  • Hospital Fundación Jimenez Díaz
  • Hospital La Paz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Men infected by HIV who have sex with men

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number and type of metabolites derived from the microbiota of patients
Detect biomarkers derived from microbiota and their relationship with the vaccine response
Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV
The proportion of subjects experiencing adverse events
Adverse events
The proportion of subjects with a severe adverse experience
Adverse events
The proportion of subjects with an adverse experience leading to disruption
Adverse events
The proportion of subjects with an adverse experience related to medication
Adverse events
The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period
Adverse events

Full Information

First Posted
July 6, 2018
Last Updated
August 24, 2023
Sponsor
Fundacion SEIMC-GESIDA
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03626467
Brief Title
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
Acronym
GESIDA10017
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion SEIMC-GESIDA
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
A phase IV, open-label and single-arm clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Men infected by HIV who have sex with men
Intervention Type
Biological
Intervention Name(s)
HPV9v
Other Intervention Name(s)
Gardasil9
Intervention Description
Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24
Primary Outcome Measure Information:
Title
Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine
Description
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
Time Frame
From basal until week 96
Secondary Outcome Measure Information:
Title
Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)
Description
The low CD4 / CD8 ratio has been associated with immunosenescence in the serological response, such as worse immunogenicity and worse response to vaccines
Time Frame
From basal until week 96
Title
Number and type of metabolites derived from the microbiota of patients
Description
Detect biomarkers derived from microbiota and their relationship with the vaccine response
Time Frame
From basal until week 96
Title
Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV
Time Frame
Basal, week 28 and week 96
Title
The proportion of subjects experiencing adverse events
Description
Adverse events
Time Frame
From basal until week 96
Title
The proportion of subjects with a severe adverse experience
Description
Adverse events
Time Frame
From basal until week 96
Title
The proportion of subjects with an adverse experience leading to disruption
Description
Adverse events
Time Frame
From basal until week 96
Title
The proportion of subjects with an adverse experience related to medication
Description
Adverse events
Time Frame
From basal until week 96
Title
The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period
Description
Adverse events
Time Frame
From basal until week 96

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Fundación Jimenez Díaz
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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