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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil® | Experimental |
| |
| Cervarix® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil | Biological | Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Avidity of HPV-16 and -18 serum antibodies measured by ELISA | Day 0, Day 45, Day 180, Day 210 and Day 365 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Østergaard, MD,PhD,DmSC | Department of Infectious Diseases, Aarhus University Hospital, Denmark | Study Director |
| Lars Toft, MD | Department of Infectious Diseases, Aarhus University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases, Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24553190 | Derived | Toft L, Tolstrup M, Muller M, Sehr P, Bonde J, Storgaard M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity of Cervarix(R) and Gardasil(R) human papillomavirus vaccines for oncogenic non-vaccine serotypes HPV-31, HPV-33, and HPV-45 in HIV-infected adults. Hum Vaccin Immunother. 2014;10(5):1147-54. doi: 10.4161/hv.27925. Epub 2014 Feb 19. | |
| 24273179 |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Cervarix | Biological | Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule. |
|
|
| 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 |
| Occurrence and intensity of solicited local symptoms | Participants will complete a vaccination diary with regards to local symptoms. Number and intensity of local symptoms will be listed and summarized. | Day 0-6 after each vaccination |
| Occurrence, intensity and relationship to vaccination of solicited general symptoms | 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. | Day 0-6 after each vaccination |
| Occurrence of SAEs | Throughout the active phase of the study (up to Day 210) |
| Occurrence of clinically relevant abnormalities in hematological and biochemical parameters | Clinical significant changes in hemoglobin, ALAT, basic phosphatase and creatinine compared to baseline values will be listed and summarized. | Throughout the active phase of the study (up to Day 210) |
| 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 | % 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) | Day 0, Day 45, Day 180, Day 210, Day 365 |
| Toft L, Storgaard M, Muller M, Sehr P, Bonde J, Tolstrup M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. J Infect Dis. 2014 Apr 15;209(8):1165-73. doi: 10.1093/infdis/jit657. Epub 2013 Nov 23. |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |