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NCT Number: 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

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)

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–36 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Fundación Jimenez Díaz, Madrid, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HPV9v

Biological

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

Other names: Gardasil9

Primary outcomes

  1. 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

  1. Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)

    Time frame: 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

  2. Number and type of metabolites derived from the microbiota of patients

    Time frame: From basal until week 96

    Detect biomarkers derived from microbiota and their relationship with the vaccine response

  3. Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV

    Time frame: Basal, week 28 and week 96

  4. The proportion of subjects experiencing adverse events

    Time frame: From basal until week 96

    Adverse events

  5. The proportion of subjects with a severe adverse experience

    Time frame: From basal until week 96

    Adverse events

  6. The proportion of subjects with an adverse experience leading to disruption

    Time frame: From basal until week 96

    Adverse events

  7. The proportion of subjects with an adverse experience related to medication

    Time frame: From basal until week 96

    Adverse events

  8. The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period

    Time frame: From basal until week 96

    Adverse events

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: GESIDA10017

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2018
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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