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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Biological: HPV9v

• Registration Number: NCT03626467
• Lead Sponsor: Fundacion SEIMC-GESIDA

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.

Study Timeline

• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Study Start: 2018-10-15
• Primary Completion: 2021-07-14
• Study Completion: 2021-07-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	HPV9v	Men infected by HIV who have sex with men

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine	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

Name	Time	Method
The proportion of subjects with an adverse experience leading to disruption	From basal until week 96	Adverse events
The proportion of subjects experiencing adverse events	From basal until week 96	Adverse events
The proportion of subjects with an adverse experience related to medication	From basal until week 96	Adverse events
Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)	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
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 with a severe adverse experience	From basal until week 96	Adverse events
Number and type of metabolites derived from the microbiota of patients	From basal until week 96	Detect biomarkers derived from microbiota and their relationship with the vaccine response
The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period	From basal until week 96	Adverse events

Trial Locations

Locations (3)

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Fundación Jimenez Díaz; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain