AzTrials
AzTrials

HIVPhase 4HIPAVACNCT01386164

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

A Phase 4 study testing Gardasil and Cervarix in people with HIV and Human Papillomavirus, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Human Papillomavirus
What is being tested?
Gardasil and Cervarix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteDenmark
Study dates
Aug 2011to Aug 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Infectious Diseases, Aarhus University Hospital

    Aarhus N, 8200

Other trials in Denmark

About this study

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.

Being tested
Gardasil, Cervarix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GardasilBiological

    Also called Tetravalent HPV vaccine

    Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

  • CervarixBiological

    Also called Bivalent HPV vaccine

    Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

Study groups in NCT01386164
Study groupRoleWhat they receive
Gardasil®ExperimentalNot described
Receives: Biological: Gardasil
Cervarix®ExperimentalNot described
Receives: Biological: Cervarix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA)

    Measured: Day 0, Day 45, Day 180, Day 210 and Day 365

Secondary outcomes (15)

  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)

    Measured: Day 0, Day 45, Day 180, Day 210 and Day 365

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

    Measured: 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

    Measured: 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

    Measured: Day 0, Day 45, Day 180, Day 210 and Day 365

  5. B-cell profile measured by Flow cytometry

    Measured: 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

    Measured: Day 0, Day 45, Day 180, Day 210 and Day 365

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

    Measured: Day 0 and Day 210

  8. CD4 cell count and HIV viral load

    Measured: Day 0, Day 45, Day 180, Day 210 and Day 365

  9. Occurrence and intensity of solicited local symptoms

    Participants will complete a vaccination diary with regards to local symptoms. Number and intensity of local symptoms will be listed and summarized.

    Measured: Day 0-6 after each vaccination

  10. Occurrence, intensity and relationship to vaccination of solicited general symptoms

    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.

    Measured: Day 0-6 after each vaccination

  11. Occurrence of SAEs

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

  12. Occurrence of clinically relevant abnormalities in hematological and biochemical parameters

    Clinical significant changes in hemoglobin, ALAT, basic phosphatase and creatinine compared to baseline values will be listed and summarized.

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

  13. Geometric mean titres of HPV-16 and HPV-18 and total Immunoglobulin G (IgG) titers in cervicovaginal secretion (CVS) from female participants

    Measured: 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)

    Measured: 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

    % 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)

    Measured: Day 0, Day 45, Day 180, Day 210, Day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2012
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01386164
Sponsor's protocol ID
LTN0001
Acronym
HIPAVAC
Status last verified
Aug 2013
First submitted
22 Jun 2011
Last updated
16 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Toft L, Tolstrup M, Muller M, Sehr P, Bonde J, Storgaard M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity of Cervarix(R) and Gardasil(R) human papillomavirus vaccines for oncogenic non-vaccine serotypes HPV-31, HPV-33, and HPV-45 in HIV-infected adults. Hum Vaccin Immunother. 2014;10(5):1147-54. doi: 10.4161/hv.27925. Epub 2014 Feb 19.

    PubMed 24553190

  • Toft L, Storgaard M, Muller M, Sehr P, Bonde J, Tolstrup M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. J Infect Dis. 2014 Apr 15;209(8):1165-73. doi: 10.1093/infdis/jit657. Epub 2013 Nov 23.

    PubMed 24273179

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gardasil and Cervarix in people with HIV and Human Papillomavirus, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01386164, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in