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Completed

NCT Number: NCT01386164

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

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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Key information

Conditions

HIV Human Papillomavirus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Infectious Diseases, Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Tetravalent HPV vaccine

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.

Other names: Bivalent HPV vaccine

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Avidity of HPV-16 and -18 serum antibodies measured by ELISA

    Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365

  3. 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

  4. 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

  5. B-cell profile measured by Flow cytometry

    Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365

  6. 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

  7. Type-specific HPV-DNA from cervical and genital swab material

    Time frame: Day 0 and Day 210

  8. CD4 cell count and HIV viral load

    Time frame: Day 0, Day 45, Day 180, Day 210 and Day 365

  9. 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.

  10. 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.

  11. Occurrence of SAEs

    Time frame: Throughout the active phase of the study (up to Day 210)

  12. 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.

  13. 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

  14. 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

  15. % 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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Acronym: HIPAVAC

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 30, 2011
Registry last updated
Aug 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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