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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 31, 2014