HIV, Human Papillomavirus
Conditions
Brief summary
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.
Interventions
BIOLOGICALGardasil
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
BIOLOGICALCervarix
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA) | Day 0, Day 45, Day 180, Day 210 and Day 365 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Avidity of HPV-16 and -18 serum antibodies measured by ELISA | Day 0, Day 45, Day 180, Day 210 and Day 365 | — |
| Frequencies of HPV-16 and HPV-18 T-cells measured by flow cytometry | Day 0, Day 45, Day 180, Day 210 and Day 365 | — |
| Frequencies of HPV-16 and -18 specific B-cells measured by B-cell ELISPOT | Day 0, Day 45, Day 180, Day 210 and Day 365 | — |
| B-cell profile measured by Flow cytometry | Day 0, Day 45, Day 180, Day 210 and Day 365 | — |
| Secretion of pro- and antiinflammatory cytokines from PBMC's stimulated with innate stimuli measured by Luminex or Elisa | Day 0, Day 45, Day 180, Day 210 and Day 365 | — |
| Type-specific HPV-DNA from cervical and genital swab material | Day 0 and Day 210 | — |
| CD4 cell count and HIV viral load | Day 0, Day 45, Day 180, Day 210 and Day 365 | — |
| Geometric mean titres of serum HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58 antibody measured by Pseudovirion-Based Neutralization Assay (PBNA) | Day 0, Day 45, Day 180, Day 210 and Day 365 | — |
| Occurrence, intensity and relationship to vaccination of solicited general symptoms | Day 0-6 after each vaccination | Participants will complete a vaccination diary with regards to general symptoms. Number and intensity of generalized symptoms will be listed and summarized in a form. |
| Occurrence of SAEs | Throughout the active phase of the study (up to Day 210) | — |
| Occurrence of clinically relevant abnormalities in hematological and biochemical parameters | Throughout the active phase of the study (up to Day 210) | Clinical significant changes in hemoglobin, ALAT, basic phosphatase and creatinine compared to baseline values will be listed and summarized. |
| Geometric mean titres of HPV-16 and HPV-18 and total Immunoglobulin G (IgG) titers in cervicovaginal secretion (CVS) from female participants | Day 0, Day 210 and Day 365 | — |
| Geometric mean titres of serum HPV-6 and HPV-11 antibody measured by a competitive Luminex immunoassay (cLIA) | To be measured at day 0, day 45, day 180, day 210 and day 365 | — |
| % of participants seropositive for anti-HPV-6, -11 -18, -31, -33, -45, -52 and -58 | Day 0, Day 45, Day 180, Day 210, Day 365 | % of participants seropositive for anti-HPV-6, -11 as measured by a competitive Luminex immunoassay (cLIA) and % of participants seropositive for anti-HPV-18, -31, -33, -45, -52 and -58 antibodies as measured by either Pseudovirion-Based Neutralization Assay (PBNA) |
| Occurrence and intensity of solicited local symptoms | Day 0-6 after each vaccination | Participants will complete a vaccination diary with regards to local symptoms. Number and intensity of local symptoms will be listed and summarized. |
Countries
Denmark
Outcome results
None listed