Efficacy of a vaccine with nine subgroups against human papilloma virus in HIV infected sexually active men who have sex with men.

Efficacy of nonavalent vaccine against human papilloma virus (HPV ) in HIV infected sexually active men who have sex with men (MSM) - HPV-VAX

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004524-65-DK

Enrollment

Registered

2015-10-28

Start date

2015-11-30

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

The purpose of the study is to investigate the efficacy of a new nonavalent HPV vaccine in sexually active HIV-infected MSM. MedDRA version: 18.1 Level: LLT Classification code 10063001 Term: Human papilloma virus infection System Organ Class: 100000004862 MedDRA version: 18.1 Level: LLT Classification code 10071147 Term: Human papilloma virus immuniz

Interventions

Product Name: Gardasil 9 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Human Papillomavirus 9-Valent Vaccine, Recombinant Other des

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • MSM • HIV-infected +/- HAART treatment ( Highly Active Antiretroviral Treatment) • Age = 18 years og =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Alcohol and/or substance use or other circumstances that makes it difficult for the study subject's ability to follow the planned studies • Known allergy to trace elements or excipients in the test drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: The presence of the virus is the most important parameter to assess the risk of HPV disease. Using a sensitive method that can detect all HPV vaccine strains and non- vaccine strains. ; Secondary Objective: The secondary endpoint is measuring the level of antibodies at month 12. Measuring the serological response towards the vaccine. ;Primary end point(s): The primary endpoint is change in the prevalence of infection with HPV vaccine strains (type 6,11,16,18, 31, 33, 45, 52, 58 ) from week 0 to week 52, as a proportion positive for at least one vaccine strain in either anus, oral cavity or penis.;Timepoint(s) of evaluation of this end point: The time point of evaluation of the primary endpoint is at month 12.	—

Measure

Time frame

Main Objective: The presence of the virus is the most important parameter to assess the risk of HPV disease. Using a sensitive method that can detect all HPV vaccine strains and non- vaccine strains. ; Secondary Objective: The secondary endpoint is measuring the level of antibodies at month 12. Measuring the serological response towards the vaccine. ;Primary end point(s): The primary endpoint is change in the prevalence of infection with HPV vaccine strains (type 6,11,16,18, 31, 33, 45, 52, 58 ) from week 0 to week 52, as a proportion positive for at least one vaccine strain in either anus, oral cavity or penis.;Timepoint(s) of evaluation of this end point: The time point of evaluation of the primary endpoint is at month 12.

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoint is measuring the level of antibodies against the vaccine at month 12. In addition observation of side effects towards the vaccine. ;Timepoint(s) of evaluation of this end point: The time point of evaluation of the primary endpoint is at month 12.	—

Countries

Denmark

Contacts

Public ContactSandra Dröse

Department of Infectious Diseases

Sandra.Droese@rsyd.dk004565412497

Outcome results

None listed

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