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

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01386164
First received: June 22, 2011
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
HIV
Human Papillomavirus
Biological: Gardasil
Biological: Cervarix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Avidity of HPV-16 and -18 serum antibodies measured by ELISA [ Time Frame: Day 0, Day 45, Day 180, Day 210 and Day 365 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • B-cell profile measured by Flow cytometry [ Time Frame: Day 0, Day 45, Day 180, Day 210 and Day 365 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Type-specific HPV-DNA from cervical and genital swab material [ Time Frame: Day 0 and Day 210 ] [ Designated as safety issue: No ]
  • CD4 cell count and HIV viral load [ Time Frame: Day 0, Day 45, Day 180, Day 210 and Day 365 ] [ Designated as safety issue: No ]
  • Occurrence and intensity of solicited local symptoms [ Time Frame: Day 0-6 after each vaccination ] [ Designated as safety issue: Yes ]
    Participants will complete a vaccination diary with regards to local symptoms. Number and intensity of local symptoms will be listed and summarized.

  • Occurrence, intensity and relationship to vaccination of solicited general symptoms [ Time Frame: Day 0-6 after each vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Throughout the active phase of the study (up to Day 210) ] [ Designated as safety issue: Yes ]
  • Occurrence of clinically relevant abnormalities in hematological and biochemical parameters [ Time Frame: Throughout the active phase of the study (up to Day 210) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 0, Day 210 and Day 365 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • % of participants seropositive for anti-HPV-6, -11 -18, -31, -33, -45, -52 and -58 [ Time Frame: Day 0, Day 45, Day 180, Day 210, Day 365 ] [ Designated as safety issue: No ]
    % 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)


Enrollment: 92
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gardasil® Biological: Gardasil
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Name: Tetravalent HPV vaccine
Experimental: Cervarix® Biological: Cervarix
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Name: Bivalent HPV vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386164

Locations
Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Study Director: Lars Østergaard, MD,PhD,DmSC Department of Infectious Diseases, Aarhus University Hospital, Denmark
Principal Investigator: Lars Toft, MD Department of Infectious Diseases, Aarhus University Hospital, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01386164     History of Changes
Other Study ID Numbers: LTN0001
Study First Received: June 22, 2011
Last Updated: August 15, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

ClinicalTrials.gov processed this record on April 16, 2014