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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Fundacion SEIMC-GESIDA
- Enrollment
- 158
- Locations
- 3
- Primary Endpoint
- Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 36 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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 \ 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.
Arms & Interventions
Arm 1
Men infected by HIV who have sex with men
Intervention: HPV9v (Biological)
Outcomes
Primary Outcomes
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 Outcomes
- The proportion of subjects with a severe adverse experience(From basal until week 96)
- The proportion of subjects with an adverse experience leading to disruption(From basal until week 96)
- The proportion of subjects experiencing adverse events(From basal until week 96)
- The proportion of subjects with an adverse experience related to medication(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)
- Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)(From basal until week 96)
- Number and type of metabolites derived from the microbiota of patients(From basal until week 96)
- The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period(From basal until week 96)