Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2019-05-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Exposure to Hepatitis B Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HBsAg + alum adjuvant

HBsAg + standard alum adjuvant

Group Type ACTIVE_COMPARATOR

HBsAg

Intervention Type DRUG

Standard hepatitis B vaccine antigen

Alum

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

HBsAg + Advax-1(TM)

HBsAg + Advax-1

Group Type EXPERIMENTAL

HBsAg

Intervention Type DRUG

Standard hepatitis B vaccine antigen

Advax-1(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

HBsAg + Advax-2(TM)

HBsAg + Advax-2

Group Type EXPERIMENTAL

HBsAg

Intervention Type DRUG

Standard hepatitis B vaccine antigen

Advax-2(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

HBsAg + Advax-3(TM)

HBsAg + Advax-3

Group Type EXPERIMENTAL

HBsAg

Intervention Type DRUG

Standard hepatitis B vaccine antigen

Advax-3(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

preS HBsAg + alum adjuvant

Group Type ACTIVE_COMPARATOR

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Alum

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

preS HBsAg + Advax-1(TM)

preS HBsAg + Advax-1

Group Type EXPERIMENTAL

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Advax-1(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

preS HBsAg + Advax-2(TM)

preS HBsAg + Advax-2

Group Type EXPERIMENTAL

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Advax-2(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

preS HBsAg + Advax-3(TM)

preS HBsAg + Advax-3

Group Type EXPERIMENTAL

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Advax-3(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

high dose preS HBsAg + alum adjuvant

Group Type ACTIVE_COMPARATOR

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Alum

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

high dose preS HBsAg + Advax-1(TM)

high dose preS HBsAg + Advax-1

Group Type EXPERIMENTAL

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Advax-1(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

high dose preS HBsAg + Advax-2(TM)

Group Type EXPERIMENTAL

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Advax-2(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

high dose preS HBsAg + Advax-3(TM)

high dose preS HBsAg + Advax-3

Group Type EXPERIMENTAL

PreS HBsAg

Intervention Type BIOLOGICAL

preS hepatitis B surface antigen

Advax-3(TM)

Intervention Type BIOLOGICAL

Adjuvant formulated with vaccine antigen

Interventions

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HBsAg

Standard hepatitis B vaccine antigen

Intervention Type DRUG

PreS HBsAg

preS hepatitis B surface antigen

Intervention Type BIOLOGICAL

Advax-1(TM)

Adjuvant formulated with vaccine antigen

Intervention Type BIOLOGICAL

Advax-2(TM)

Adjuvant formulated with vaccine antigen

Intervention Type BIOLOGICAL

Advax-3(TM)

Adjuvant formulated with vaccine antigen

Intervention Type BIOLOGICAL

Alum

Adjuvant formulated with vaccine antigen

Intervention Type BIOLOGICAL

Other Intervention Names

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hepatitis B vaccine based on hepatitis B surface antigen preS hepatitis B surface antigen Delta inulin adjuvant Supermix Alhydrogel Aluminium hydroxide

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes