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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: HPV9v


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |