A trial to evaluate the immunogenicity of vaccine against human papillomavirus in HIV-infected men who have sex with men. GESIDA 10017 Study

A single-arm, open-label and multicentre phase IV trial to evaluate the immunogenicity of the nonavalent vaccine against human papillomavirus in HIV-infected men who have sex with men. GESIDA 10017 Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000215-24-ES

Enrollment

166

Registered

2018-05-21

Start date

2018-06-05

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Interventions

Trade Name: Gardasil 9 Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN Other descriptive name: HUMAN PAPILLOMAVIRUS TYPE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients able to give their written consent to participate in the study. - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 166 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous history of anal cancer. - Have previously received any vaccine against HPV.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men by determining, in two age groups, of the incidence of seroconversion for each of the HPV genotypes included in the HPV9v vaccine from baseline to month 7 and month 24.;Secondary Objective: - To evaluate as predictive factors of the immunogenicity of the HPV9 vaccine to: age group, CD4 / CD8 index and the anal microbiome. - Determine mechanisms derived from the anal microbiome associated with the immunogenicity of the HPV9 vaccine.;Primary end point(s): - Percentage of sero-converting subjects for each of the following HPV genotypes studied (6/11/16/18/31/33/45/52/58) from the baseline visit to week 28 and 96. The points of cut to determine serostatus will be 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 [1]. - Ratio of the geometric mean of antibody titers from baseline to week 96 for HPV 6/11/16/18/31/33/45/52/58.;Timepoint(s) of evaluation of this end point: Basal visit, week 28 and week 96	—

Measure

Time frame

Main Objective: To evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men by determining, in two age groups, of the incidence of seroconversion for each of the HPV genotypes included in the HPV9v vaccine from baseline to month 7 and month 24.;Secondary Objective: - To evaluate as predictive factors of the immunogenicity of the HPV9 vaccine to: age group, CD4 / CD8 index and the anal microbiome. - Determine mechanisms derived from the anal microbiome associated with the immunogenicity of the HPV9 vaccine.;Primary end point(s): - Percentage of sero-converting subjects for each of the following HPV genotypes studied (6/11/16/18/31/33/45/52/58) from the baseline visit to week 28 and 96. The points of cut to determine serostatus will be 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 [1]. - Ratio of the geometric mean of antibody titers from baseline to week 96 for HPV 6/11/16/18/31/33/45/52/58.;Timepoint(s) of evaluation of this end point: Basal visit, week 28 and week 96

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Secondary

Measure	Time frame
Secondary end point(s): - Persistent anal infection by HPV 6/11/16/18/31/33/45/52/58. - Detection of HPV DNA in the anal brushing of the final visit in those free of infection at the baseline visit. - Combined variable: persistent HPV infection 6/11/16/18/31/33/45/52/58 or isolated DNA detection at the final visit in those free of infection at the baseline visit;Timepoint(s) of evaluation of this end point: Basal visit, week 28 and week 96	—

Measure

Time frame

Secondary end point(s): - Persistent anal infection by HPV 6/11/16/18/31/33/45/52/58. - Detection of HPV DNA in the anal brushing of the final visit in those free of infection at the baseline visit. - Combined variable: persistent HPV infection 6/11/16/18/31/33/45/52/58 or isolated DNA detection at the final visit in those free of infection at the baseline visit;Timepoint(s) of evaluation of this end point: Basal visit, week 28 and week 96

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Countries

Spain

Contacts

Public ContactMaria Yllescas

Fundación SEIMC-GESIDA

myllescas@f-sg.org0034915568025

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026