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

HIV Infections Clinical Trial

— GESIDA10017  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626467
• Other study ID #: GESIDA10017
• Status: Completed
• Phase: Phase 4
• Start date: October 15, 2018
• Est. completion date: July 14, 2021

Study information

• Verified date: August 2023
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• HPV9v
Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24

Locations

Country	Name	City	State
Spain	Hospital Fundación Jimenez Díaz	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of participants <26 years and = 26 years with persistent anal infection due to HPV		Basal, week 28 and week 96
Secondary	The proportion of subjects experiencing adverse events	Adverse events	From basal until week 96
Secondary	The proportion of subjects with a severe adverse experience	Adverse events	From basal until week 96
Secondary	The proportion of subjects with an adverse experience leading to disruption	Adverse events	From basal until week 96
Secondary	The proportion of subjects with an adverse experience related to medication	Adverse events	From basal until week 96
Secondary	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