Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults (HIPAVAC)

University of Aarhus

Status and phase

Completed

Phase 4

Conditions

HIV

Human Papillomavirus

Treatments

Biological: Gardasil

Biological: Cervarix

Study type

Interventional

Funder types

Other

Identifiers

NCT01386164

LTN0001

Details and patient eligibility

About

The purpose of this study is to analyze and compare the immunogenicity of Bivalent and Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV positive subjects.
Age above 18 at the time of the first vaccination.
Written informed consent obtained from the subject.
Subjects whom the investigator believes can and will comply with the requirements of the protocol.
If currently on antiretroviral therapy (ART), subjects must be compliant to triple therapy (highly active ART) and have undetectable viral load for a period of six months prior to study entry.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period.

Exclusion criteria

Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 12).
Pregnant or breastfeeding female.
Previous enrollment in the study.
Subjects whom the investigator believes cannot and/or will not comply with the requirements of the protocol (i.e. because of abuse of drugs or alcohol, dementia or given medical, psychiatric, social or work related conditions).
Chronic administration of immunosuppressive drugs
Cancer or autoimmune disease
Previous allergic reaction to vaccination
Known allergy towards on or more components of either of the test drugs.