Trial record 4 of 435 for:    hepatitis b | Open Studies

Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Vaxine Pty Ltd
Sponsor:
Collaborator:
Flinders Medical Centre
Information provided by (Responsible Party):
Vaxine Pty Ltd
ClinicalTrials.gov Identifier:
NCT01951677
First received: September 16, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Exposure to Hepatitis B Virus
Drug: HBsAg
Biological: PreS HBsAg
Biological: Advax-1(TM)
Biological: Advax-2(TM)
Biological: Advax-3(TM)
Biological: Alum
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Vaxine Pty Ltd:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety as assessed by incidence of adverse events


Secondary Outcome Measures:
  • Hepatitis B surface antibody geometric mean titer [ Time Frame: one-month post each immunization and 10 months post-final immunization ] [ Designated as safety issue: No ]
    Geometric mean titer of HBsAg titers

  • T cell responses [ Time Frame: 7 days and one month post each immunization and 10 months post-final immunization ] [ Designated as safety issue: No ]
    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

  • Efficacy [ Time Frame: one month post each immunization and 10 months post final immunization ] [ Designated as safety issue: No ]
    Seroconversion and seroprotection rates will be compared between groups using titers of antibodies to hepatitis B surface antigen at each major time point


Estimated Enrollment: 240
Study Start Date: July 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HBsAg + alum adjuvant
HBsAg + standard alum adjuvant
Drug: HBsAg
Standard hepatitis B vaccine antigen
Other Name: hepatitis B vaccine based on hepatitis B surface antigen
Biological: Alum
Adjuvant formulated with vaccine antigen
Other Names:
  • Alhydrogel
  • Aluminium hydroxide
Experimental: HBsAg + Advax-1(TM)
HBsAg + Advax-1
Drug: HBsAg
Standard hepatitis B vaccine antigen
Other Name: hepatitis B vaccine based on hepatitis B surface antigen
Biological: Advax-1(TM)
Adjuvant formulated with vaccine antigen
Other Name: Delta inulin adjuvant
Experimental: HBsAg + Advax-2(TM)
HBsAg + Advax-2
Drug: HBsAg
Standard hepatitis B vaccine antigen
Other Name: hepatitis B vaccine based on hepatitis B surface antigen
Biological: Advax-2(TM)
Adjuvant formulated with vaccine antigen
Other Name: Supermix
Experimental: HBsAg + Advax-3(TM)
HBsAg + Advax-3
Drug: HBsAg
Standard hepatitis B vaccine antigen
Other Name: hepatitis B vaccine based on hepatitis B surface antigen
Biological: Advax-3(TM)
Adjuvant formulated with vaccine antigen
Active Comparator: preS HBsAg + alum adjuvant
preS HBsAg + alum adjuvant
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Alum
Adjuvant formulated with vaccine antigen
Other Names:
  • Alhydrogel
  • Aluminium hydroxide
Experimental: preS HBsAg + Advax-1(TM)
preS HBsAg + Advax-1
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Advax-1(TM)
Adjuvant formulated with vaccine antigen
Other Name: Delta inulin adjuvant
Experimental: preS HBsAg + Advax-2(TM)
preS HBsAg + Advax-2
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Advax-2(TM)
Adjuvant formulated with vaccine antigen
Other Name: Supermix
Experimental: preS HBsAg + Advax-3(TM)
preS HBsAg + Advax-3
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Advax-3(TM)
Adjuvant formulated with vaccine antigen
Active Comparator: high dose preS HBsAg + alum adjuvant
high dose preS HBsAg + alum adjuvant
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Alum
Adjuvant formulated with vaccine antigen
Other Names:
  • Alhydrogel
  • Aluminium hydroxide
Experimental: high dose preS HBsAg + Advax-1(TM)
high dose preS HBsAg + Advax-1
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Advax-1(TM)
Adjuvant formulated with vaccine antigen
Other Name: Delta inulin adjuvant
Experimental: high dose preS HBsAg + Advax-2(TM)
high dose preS HBsAg + Advax-2(TM)
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Advax-2(TM)
Adjuvant formulated with vaccine antigen
Other Name: Supermix
Experimental: high dose preS HBsAg + Advax-3(TM)
high dose preS HBsAg + Advax-3
Biological: PreS HBsAg
preS hepatitis B surface antigen
Other Name: preS hepatitis B surface antigen
Biological: Advax-3(TM)
Adjuvant formulated with vaccine antigen

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951677

Contacts
Contact: Chamindi Abeyratne, BSc 0882044572 Chamindi.Abeyratne@health.sa.gov.au

Locations
Australia, South Australia
Flinders Medical Centre Recruiting
Adelaide, South Australia, Australia, 5042
Contact: Chamindi Abeyratne, BSc    0882044572    Chamindi.Abeyratne@health.sa.gov.au   
Principal Investigator: Jeffrey Barbara, MBBS PhD         
Sub-Investigator: Nikolai Petrovsky, MBBS PhD         
Sponsors and Collaborators
Vaxine Pty Ltd
Flinders Medical Centre
Investigators
Principal Investigator: Jeffrey Barbara, MBBS PhD Flinders Medical Centre
  More Information

No publications provided

Responsible Party: Vaxine Pty Ltd
ClinicalTrials.gov Identifier: NCT01951677     History of Changes
Other Study ID Numbers: HBV002
Study First Received: September 16, 2013
Last Updated: September 23, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Vaxine Pty Ltd:
hepatitis B virus
vaccine
adjuvant
prophylaxis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Aluminum Hydroxide
Aluminum sulfate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014