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

Phase 1

• 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 immunization System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-004524-65-DK
• Lead Sponsor: Department of Infectious Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

•MSM
•HIV-infected +/- HAART treatment ( Highly Active Antiretroviral Treatment)
•Age = 18 years og < 52 years
•Minimum one sexuel contact within the last month
•No earlier history of anal, penil or oro/pharyngeal neoplasi
•Able to understand and give informed consent
•Not previously vaccinated with HPV

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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified