HIV Human Papilloma Virus MedDRA version: 13.1 Level: LLT Classification code 10020443 Term: Human immunodeficiency virus syndrome System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: LLT Classification code 10063001 Term: Human papilloma virus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Gardasil
Product Name: Gardasil
Pharmaceutical Form: Injection
Other descriptive name: HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN ADSORBED ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE
Con
Sponsors
Department of Infectious Diseases - Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare induction of anti-HPV-16 and -18 antibodies in the bivalent HPV vaccine group vs. the Tetravalent HPV vaccine group as measured by pseudovirion neutralization titer.;Secondary Objective: - To evaluate and compare induction of cross protection against other HPV-serotypes in the bivalent HPV vaccine group vs. the Tetravalent HPV vaccine group. - To evaluate tolerance and safety of Bivalent and Tetravalent HPV vaccines in HIV infected adults. - To compare the induction of immunological memory against HPV-6, -11, -16 and -18 in the bivalent HPV vaccine group vs. the Tetravalent HPV vaccine group. - To screen study participants for prevalent HPV-infection and investigate for serological evidence of previous HPV-infection - To compare antibody responses to HPV vaccination in patients receiving HAART and patients not receiving HAART. - To compare induction of cellular immunity against vaccine-specific HPV-types in the bivalent HPV vaccine group vs. the Tetravalent HPV vaccine group. - To assess induction of innate immune activation after vaccination with either of the HPV-vaccines. - To assess if HAART-treatment can predict vaccine response.;Primary end point(s): - Quantitative measurement of Serum Neutralization titer of anti-HPV-16 and -18 antibodies ;Timepoint(s) of evaluation of this end point: - Day 210 from first vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number and intensity of adverse and serious adverse events. - Induction of antibodies cross reactive to toher HPV serotypes - HPV specific B-cell analyses. - B-cell phenotype specific analyses. - HPV specific T-cell analyses. - T-cell phenotype specific analyses. - HPV specific cell mediated immune response: Secretion of IFN gamma, TNF alfa and IL-2 when stimulated with HPV antigen. Quantitative measures of cytokine producing T-cells with subsequent flow cytometry. - Changes in HPV-DNA from material obtained from cervix (females), rectum and tonsils. - Non-specific innate immune activation and responsivity.;Timepoint(s) of evaluation of this end point: - Safety issues are evaluated after each vaccination. - Other outcomes are evaluated at day 0, day 45, day 180, day 210 and day 360 | — |
Countries
Denmark
Contacts
Public ContactResearch Department
Department of Infectious Diseases, Aarhus University Hospital
Outcome results
None listed