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)

• ClinicalTrials.gov Identifier: NCT03626467
• Recruitment Status: Unknown
• First Posted: August 13, 2018
• Last Update Posted: February 5, 2020
• Sponsor: Fundacion SEIMC-GESIDA
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Fundacion SEIMC-GESIDA

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)

Condition or disease	Intervention/treatment	Phase
HIV Infections	Biological: HPV9v	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• 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
• Actual Study Start Date: October 15, 2018
• Estimated Primary Completion Date: December 15, 2020
• Estimated Study Completion Date: December 15, 2021

Arms and Interventions

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 Name: Gardasil9

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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
2. 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
3. Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV [ Time Frame: Basal, week 28 and week 96 ]
4. The proportion of subjects experiencing adverse events [ Time Frame: From basal until week 96 ]
   Adverse events
5. The proportion of subjects with a severe adverse experience [ Time Frame: From basal until week 96 ]
   Adverse events
6. The proportion of subjects with an adverse experience leading to disruption [ Time Frame: From basal until week 96 ]
   Adverse events
7. The proportion of subjects with an adverse experience related to medication [ Time Frame: From basal until week 96 ]
   Adverse events
8. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 36 Years (Adult)
• 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 <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.

Contacts and Locations

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

• Responsible Party: Fundacion SEIMC-GESIDA
• ClinicalTrials.gov Identifier: NCT03626467
• Other Study ID Numbers: GESIDA10017
• First Posted: August 13, 2018
• Last Update Posted: February 5, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

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