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

August 15, 2013 updated by: University of Aarhus
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Department of Infectious Diseases, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Bivalent HPV vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Day 0, Day 45, Day 180, Day 210 and Day 365

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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.
Day 0-6 after each vaccination
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.
Day 0-6 after each vaccination
Occurrence of SAEs
Time Frame: Throughout the active phase of the study (up to Day 210)
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.
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
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
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)
Day 0, Day 45, Day 180, Day 210, Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LTN0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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