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Exposure to Hepatitis B VirusPhase 1NCT01951677

Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

A Phase 1 study testing HBsAg, PreS HBsAg and Advax-1(TM) in people with Exposure to Hepatitis B Virus, run by Vaxine Pty Ltd at 1 site in Australia.

Completed

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

Official record
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Trial summary

There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Exposure to Hepatitis B Virus
What is being tested?
HBsAg, PreS HBsAg and Advax-1(TM)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteAustralia
Study dates
Jul 2013to May 2019
Phase
Phase 1
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years and above
  • Male or female
  • Able to provide written informed consent
  • Willing and able to comply with the protocol for the duration of the study.
  • Has one or more of
  • Age 40 years or above
  • Impaired renal function (creatinine >120 mmol/L or calculated glomerular filtration rate <60mls/min)
  • Diagnosis of diabetes mellitus (any type)

Who cannot join

  • History of prior hepatitis B vaccination
  • History of serious vaccine allergy if in the opinion of the Investigator this represents a contraindication to hepatitis B vaccination
  • Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device.
  • Pregnant or lactating women.
  • History of systemic autoimmune disease including Wegener's granulomatosis, systemic lupus erythematosus, Guillain-Barre, scleroderma or multiple sclerosis.
  • Participation in another clinical trial with an investigational agent within 28 days of the scheduled date of first immunization.
  • Any other serious medical, social or mental condition that, in the opinion of the investigator, would be detrimental to the subjects or the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

Other trials in Australia

About this study

Official title: Phase 1 Randomized, Controlled, Double-blind Study to Compare the Safety and Effectiveness of Hepatitis B Vaccines in Individuals With Renal Impairment, Diabetes Mellitus or Age Greater Than 40 Years

There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development

Read the detailed description

Adjuvants are a critical ingredient in most vaccines and act by boosting the immune response to the target protein (e.g. hepatitis B surface antigen (HBsAg)). Despite considerable research, aluminium hydroxide or phosphate compounds (collectively referred to as "alum") remain the dominant adjuvants used in human hepatitis B virus vaccines. There is thus an unmet need for new HBV vaccine adjuvants, in particular, for adjuvants capable of boosting cell-mediated immunity (this is a particular type of immune response where killer T cells are activated that are then able to attack and destroy the infection) as alum, although good at stimulating antibodies is very poor at stimulating cell-mediated immunity. Alum, whilst generally accepted as safe, can be associated with significant local vaccine reactions and this is another reason why newer better-tolerated vaccine adjuvants would be beneficial. This study will compare a range of experimental adjuvant formulations to identify those that provide the safest and most effective enhancement of T- and B-cell immunity against hepatitis B

Being tested
HBsAg, PreS HBsAg, Advax-1(TM), Advax-2(TM), Advax-3(TM)
Keywords
hepatitis B virus, vaccine, adjuvant, prophylaxis
Medical subject headings
Hepatitis B

What participants receive

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

  • HBsAgDrug

    Also called hepatitis B vaccine based on hepatitis B surface antigen

    Standard hepatitis B vaccine antigen

  • PreS HBsAgBiological

    Also called preS hepatitis B surface antigen

    preS hepatitis B surface antigen

  • Advax-1(TM)Biological

    Also called Delta inulin adjuvant

    Adjuvant formulated with vaccine antigen

  • Advax-2(TM)Biological

    Also called Supermix

    Adjuvant formulated with vaccine antigen

  • Advax-3(TM)Biological

    Adjuvant formulated with vaccine antigen

  • AlumBiological

    Also called Alhydrogel, Aluminium hydroxide

    Adjuvant formulated with vaccine antigen

Study groups in NCT01951677
Study groupRoleWhat they receive
HBsAg + alum adjuvantActive comparatorHBsAg + standard alum adjuvant
Receives: Drug: HBsAg; Biological: Alum
HBsAg + Advax-1(TM)ExperimentalHBsAg + Advax-1
Receives: Drug: HBsAg; Biological: Advax-1(TM)
HBsAg + Advax-2(TM)ExperimentalHBsAg + Advax-2
Receives: Drug: HBsAg; Biological: Advax-2(TM)
HBsAg + Advax-3(TM)ExperimentalHBsAg + Advax-3
Receives: Drug: HBsAg; Biological: Advax-3(TM)
preS HBsAg + alum adjuvantActive comparatorpreS HBsAg + alum adjuvant
Receives: Biological: PreS HBsAg; Biological: Alum
preS HBsAg + Advax-1(TM)ExperimentalpreS HBsAg + Advax-1
Receives: Biological: PreS HBsAg; Biological: Advax-1(TM)
preS HBsAg + Advax-2(TM)ExperimentalpreS HBsAg + Advax-2
Receives: Biological: PreS HBsAg; Biological: Advax-2(TM)
preS HBsAg + Advax-3(TM)ExperimentalpreS HBsAg + Advax-3
Receives: Biological: PreS HBsAg; Biological: Advax-3(TM)
high dose preS HBsAg + alum adjuvantActive comparatorhigh dose preS HBsAg + alum adjuvant
Receives: Biological: PreS HBsAg; Biological: Alum
high dose preS HBsAg + Advax-1(TM)Experimentalhigh dose preS HBsAg + Advax-1
Receives: Biological: PreS HBsAg; Biological: Advax-1(TM)
high dose preS HBsAg + Advax-2(TM)Experimentalhigh dose preS HBsAg + Advax-2(TM)
Receives: Biological: PreS HBsAg; Biological: Advax-2(TM)
high dose preS HBsAg + Advax-3(TM)Experimentalhigh dose preS HBsAg + Advax-3
Receives: Biological: PreS HBsAg; Biological: Advax-3(TM)

What is being measured

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

  1. Safety

    Safety as assessed by incidence of adverse events

    Measured: 12 months

Secondary outcomes (3)

  1. Hepatitis B surface antibody geometric mean titer

    Geometric mean titer of HBsAg titers

    Measured: one-month post each immunization and 10 months post-final immunization

  2. T cell responses

    HBsAg-specific T cell responses as measured by cytokine enzyme-linked immunospot and carboxyfluorescein diacetate succinimidyl ester T-cell proliferation assay will be compared between groups

    Measured: 7 days and one month post each immunization and 10 months post-final immunization

  3. Efficacy

    Seroconversion and seroprotection rates will be compared between groups using titers of antibodies to hepatitis B surface antigen at each major time point

    Measured: one month post each immunization and 10 months post final immunization

Timeline

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

  1. First posted27 Sep 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2017
  4. Study completionMay 2019

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951677
Sponsor's protocol ID
HBV002
Status last verified
May 2019
First submitted
16 Sep 2013
Last updated
7 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Currently no plan

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HBsAg, PreS HBsAg and Advax-1(TM) in people with Exposure to Hepatitis B Virus, run by Vaxine Pty Ltd at 1 site in Australia.

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 8 inclusion and 7 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 7 May 2019. 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 Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety (time frame: 12 months). 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 NCT01951677.

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 7 May 2019.

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