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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
92
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Department of Infectious Diseases, Aarhus University Hospital
Aarhus N, Denmark
Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA)
Time frame: 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)
Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365
Avidity of HPV-16 and -18 serum antibodies measured by ELISA
Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365
Frequencies of HPV-16 and HPV-18 T-cells measured by flow cytometry
Time frame: 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
Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365
B-cell profile measured by Flow cytometry
Time frame: 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
Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365
Type-specific HPV-DNA from cervical and genital swab material
Time frame: Day 0 and Day 210
CD4 cell count and HIV viral load
Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365
Occurrence and intensity of solicited local symptoms
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will complete a vaccination diary with regards to local symptoms. Number and intensity of local symptoms will be listed and summarized.
Time frame: 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.
Time frame: Day 0-6 after each vaccination
Occurrence of SAEs
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Day 0, Day 45, Day 180, Day 210, Day 365