Clinical Trials

MainTitle

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)

This study is ongoing, but not recruiting participants.
Sponsor
Fundacion SEIMC-GESIDA

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier
NCT03626467

First received: July 6, 2018
Last updated: February 3, 2020
Last Verified: February 2020
History of Changes
Purpose

Purpose

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)

Condition Intervention Phase
HIV Infections

Biological : HPV9v
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A phase IV, open-label and single-arm clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures

  • Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine [ Time Frame: From basal until week 96 ]
    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) [ Time Frame: From basal until week 96 ]
    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 [ Time Frame: From basal until week 96 ]
    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 [ Time Frame: Basal, week 28 and week 96 ]
  • The proportion of subjects experiencing adverse events [ Time Frame: From basal until week 96 ]
    Adverse events
  • The proportion of subjects with a severe adverse experience [ Time Frame: From basal until week 96 ]
    Adverse events
  • The proportion of subjects with an adverse experience leading to disruption [ Time Frame: From basal until week 96 ]
    Adverse events
  • The proportion of subjects with an adverse experience related to medication [ Time Frame: From basal until week 96 ]
    Adverse events
  • The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period [ Time Frame: From basal until week 96 ]
    Adverse events

Enrollment: 158
Study Start Date: October 15, 2018
Estimated Study Completion Date: December 15, 2021
Estimated Primary Completion Date: December 15, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: Gardasil9

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 36 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

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 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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03626467

Locations

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

Sponsors and Collaborators

Fundacion SEIMC-GESIDA
Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Fundacion SEIMC-GESIDA  
ClinicalTrials.gov Identifier: NCT03626467   History of Changes  
Other Study ID Numbers: GESIDA10017  
Study First Received: July 6, 2018  
Last Updated: February 3, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.