Comparison of vaccine effects of two different vaccines against Human Papillomavirus in HIV infected people

• Conditions: HIVHuman Papilloma Virus; MedDRA version: 13.1Level: LLTClassification code 10020443Term: Human immunodeficiency virus syndromeSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001871-37-DK
• Lead Sponsor: Department of Infectious Diseases - Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-31
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

1) Written informed consent and authority statement provided according to local regulatory and ethical practice using a participant information sheet and informed consent form approved by the responsible Ethics Committee.
2) Male or female participants = 18 years.
3) HIV-seropositive individuals.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Pregnancy as determined by a positive urine beta-hCG (if female)
2) Participants unwilling to use reliable contraception for the duration of the trial (if female). Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral and transdermal delivery, surgical sterilization, vaginal ring, intrauterine device, abstinence and post-menopause (if female).
3) Currently breast-feeding (if female)
4) Viral load (HIV-RNA) > 50 copies/mL if on HAART
5) Previous enrolment in the study
6) Any medical, psychiatric, social or occupational condition that, in the judgement of the Principal Investigator (PI) would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse and dementia)
7) Unable to follow protocol regimen
8) Previous HPV-vaccination
9) Planned participation in other vaccination trials during the time of the study.
10) Cancer, autoimmune disease or chronic administration of systemic immunosuppressive drugs.

Study & Design

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