A Phase 1 interventional study of HBsAg and PreS HBsAg in Exposure to Hepatitis B Virus, sponsored by Vaxine Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by Vaxine Pty Ltd · Phase 1, Interventional, and Prevention
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
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
1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.
This study's planned enrollment of 240 is above the median of 120 across 1,191 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Vaxine Pty Ltd is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
HBsAg + standard alum adjuvant
Drug: HBsAg · Biological: Alum
HBsAg + Advax-1
Drug: HBsAg · Biological: Advax-1(TM)
HBsAg + Advax-2
Drug: HBsAg · Biological: Advax-2(TM)
HBsAg + Advax-3
Drug: HBsAg · Biological: Advax-3(TM)
preS HBsAg + alum adjuvant
Biological: PreS HBsAg · Biological: Alum
preS HBsAg + Advax-1
Biological: PreS HBsAg · Biological: Advax-1(TM)
preS HBsAg + Advax-2
Biological: PreS HBsAg · Biological: Advax-2(TM)
preS HBsAg + Advax-3
Biological: PreS HBsAg · Biological: Advax-3(TM)
high dose preS HBsAg + alum adjuvant
Biological: PreS HBsAg · Biological: Alum
high dose preS HBsAg + Advax-1
Biological: PreS HBsAg · Biological: Advax-1(TM)
high dose preS HBsAg + Advax-2(TM)
Biological: PreS HBsAg · Biological: Advax-2(TM)
high dose preS HBsAg + Advax-3
Biological: PreS HBsAg · Biological: Advax-3(TM)
Standard hepatitis B vaccine antigen
Also known as: hepatitis B vaccine based on hepatitis B surface antigen
preS hepatitis B surface antigen
Also known as: preS hepatitis B surface antigen
Adjuvant formulated with vaccine antigen
Also known as: Delta inulin adjuvant
Adjuvant formulated with vaccine antigen
Also known as: Supermix
Adjuvant formulated with vaccine antigen
Drug pages: Aluminum sulfate · Aluminium sulfate
Adjuvant formulated with vaccine antigen
Also known as: Alhydrogel, Aluminium hydroxide
Safety
Safety as assessed by incidence of adverse events
Time frame: 12 months
Hepatitis B surface antibody geometric mean titer
Geometric mean titer of HBsAg titers
Time frame: one-month post each immunization and 10 months post-final immunization
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
Time frame: 7 days and one month post each immunization and 10 months post-final immunization
Efficacy
Seroconversion and seroprotection rates will be compared between groups using titers of antibodies to hepatitis B surface antigen at each major time point
Time frame: one month post each immunization and 10 months post final immunization
Plan to share: No — Currently no plan
No publications or documents are linked to this record.
Ran from Jul 2013 to primary completion in Oct 2017, 51 months.
Of 92 industry-sponsored phase 1 interventional studies under Hepatitis B, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 51 months is above that.
Counting every sponsor, half of 104 studies reached it within 15 months; a quarter within 7 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hepatitis B Surface Antigens
Vaxine Pty Ltd