Clinical trial NCT03626467: 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
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-08-13
Enrollment: 158
Sex: MALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A phase IV, open-label and single-arm clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine
timeFrame: From basal until week 96
Secondary outcomes:
measure: Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)
timeFrame: From basal until week 96
measure: Number and type of metabolites derived from the microbiota of patients
timeFrame: From basal until week 96
measure: Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV
timeFrame: Basal, week 28 and week 96
measure: The proportion of subjects experiencing adverse events
timeFrame: From basal until week 96
measure: The proportion of subjects with a severe adverse experience
timeFrame: From basal until week 96
measure: The proportion of subjects with an adverse experience leading to disruption
timeFrame: From basal until week 96
measure: The proportion of subjects with an adverse experience related to medication
timeFrame: From basal until week 96
measure: The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period
timeFrame: From basal until week 96
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
References: