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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Aarhus

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
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults

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 ]
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 ]
  • 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 [ Time Frame: 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.
  • Occurrence, intensity and relationship to vaccination of solicited general symptoms [ Time Frame: 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 [ Time Frame: Throughout the active phase of the study (up to Day 210) ]
  • Occurrence of clinically relevant abnormalities in hematological and biochemical parameters [ Time Frame: 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 [ 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 [ Time Frame: 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)

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


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  

Additional relevant MeSH terms:
Vaccines

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.