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HIV InfectionPhase 3NCT01289106

Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects

A Phase 3 study testing Hepavax-Gene in people with HIV Infection, run by Chiang Mai University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV Infection
What is being tested?
Hepavax-Gene
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteThailand
Study dates
Jan 2011to Apr 2012
Phase
Phase 3
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Positive for anti-HIV antibody
  • At least 18 years of age
  • CD4 > 200 cell/mm3
  • On antiretroviral therapy
  • Viral load < 50 copies/ml
  • Negative for any HBV serological marker (HBsAg, Anti-HBs, Anti-HBc)
Show all 11Show fewer
  • No history of previous hepatitis B vaccination
  • Anti-HCV negative
  • No active opportunistic infection at the time of screening
  • Willing to sign informed consent
  • Able to follow up

Who cannot join

  • Pregnancy or breast feeding
  • History of hypersensitivity to any component of vaccine
  • Diagnosis of malignancy and receiving chemotherapy or radiation
  • Other immunocompromised conditions not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
  • On Immunosuppressive treatment, immunomodulating treatment or corticosteroid (equal or above 0.5 mg per kg per day of prednisolone)
  • Renal failure (creatinine clearance < 30 mL/min)
  • Decompensated cirrhosis (child-pugh C)
  • Not able to follow up

Trial locations and contacts

1 site in 1 country.

Kanokporn Chaiklang, MD contact

+66 89 8539864

kanokpornk@rihes.org

Thailand1 site, 1 recruiting

  • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

    Muang, Chiang Mai, 50200

    Kanokporn Chaiklang, MD, +66 89 8539864, kanokpornk@rihes.org

    Kanokporn Chaiklang, MD

    Recruiting

Other trials in Thailand

About this study

Official title: Open-Label, Randomized Controlled Trial Comparing Three Strategies of Hepatitis B Vaccination in HIV-1-Infected Patients With CD4 Cell Counts Above 200 permm3 and Suppressed Viral Load

The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.

Read the detailed description

HIV and HBV share similar risk factors and routes of transmission. HIV/HBV coinfection is associated with greater chance of chronic HBV carrier state, higher level of HBV replication and increasing its potential for transmission. Currently, there are no concrete data to determine the best HBV vaccination schedule in HIV-infected patients. Standard HBV vaccination (20 μg at 0, 1 and 6 months) gives seroconversion rate of 33-63% in HIV-infected individuals compared with >90% in healthy individuals. This study aims to compare the efficacy of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) and to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients with CD4 level above 200 permm3 and suppressed viral load.

Conditions
HIV Infection
Being tested
Hepavax-Gene
Keywords
Hepatitis B vaccine, HIV infection, Modified HBV vaccine dose, Modified HBV vaccine schedule
Medical subject headings
HIV Infections, Hepatitis B

What participants receive

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

  • Hepavax-GeneBiological

    Also called Berna

    20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months

  • Hepavax-GeneBiological

    Also called Berna

    20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

  • Hepavax-GeneBiological

    Also called Berna

    40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Study groups in NCT01289106
Study groupRoleWhat they receive
Arm AActive comparator20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
Receives: Biological: Hepavax-Gene
Arm BExperimental20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Receives: Biological: Hepavax-Gene
Arm CExperimental40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Receives: Biological: Hepavax-Gene

What is being measured

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

  1. Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210

    1. To compare the seroconversion rate at day 210 of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months)
    2. To compare the seroconversion rate at day 210 of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients

    Measured: Day 210

Secondary outcomes (2)

  1. Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year

    To determine the seroprotective rate at 1 year of each of the vaccination regimens.

    Measured: 1 year

  2. Number of subjects with adverse events after vaccination

    Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis

    Measured: 180 days

Timeline

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

  1. First posted3 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2011 (estimated)
  4. Study completionApr 2012 (estimated)

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01289106
Sponsor's protocol ID
MED-10-10-21A-13
Status last verified
Jan 2011
First submitted
1 Feb 2011
Last updated
3 Feb 2011
Results posted
No
Data monitoring committee
No

Publications

  • Chaiwarith R, Praparattanapan J, Kotarathititum W, Wipasa J, Chaiklang K, Supparatpinyo K. Higher rate of long-term serologic response of four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: 4-year follow-up of a randomised controlled trial. AIDS Res Ther. 2019 Nov 11;16(1):33. doi: 10.1186/s12981-019-0249-8.

    PubMed 31711528

  • Chawansuntati K, Chaiklang K, Chaiwarith R, Praparattanapan J, Supparatpinyo K, Wipasa J. Hepatitis B Vaccination Induced TNF-alpha- and IL-2-Producing T Cell Responses in HIV- Healthy Individuals Higher than in HIV+ Individuals Who Received the Same Vaccination Regimen. J Immunol Res. 2018 Feb 27;2018:8350862. doi: 10.1155/2018/8350862. eCollection 2018.

    PubMed 29682590

  • Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial. PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013.

    PubMed 24265819

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hepavax-Gene in people with HIV Infection, run by Chiang Mai University at 1 site in Thailand.

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 11 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: status not confirmed, as of the sponsor's last update on 3 Feb 2011. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Kanokporn Chaiklang, MD (+66 89 8539864, kanokpornk@rihes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210 (time frame: Day 210). 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 NCT01289106, which also lists 3 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 3 Feb 2011.

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