Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine
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
1 other identifier
interventional
240
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 16, 2013
CompletedFirst Posted
Study publicly available on registry
September 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMay 7, 2019
May 1, 2019
4.3 years
September 16, 2013
May 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Safety as assessed by incidence of adverse events
12 months
Secondary Outcomes (3)
Hepatitis B surface antibody geometric mean titer
one-month post each immunization and 10 months post-final immunization
T cell responses
7 days and one month post each immunization and 10 months post-final immunization
Efficacy
one month post each immunization and 10 months post final immunization
Study Arms (12)
HBsAg + alum adjuvant
ACTIVE COMPARATORHBsAg + standard alum adjuvant
HBsAg + Advax-1(TM)
EXPERIMENTALHBsAg + Advax-1
HBsAg + Advax-2(TM)
EXPERIMENTALHBsAg + Advax-2
HBsAg + Advax-3(TM)
EXPERIMENTALHBsAg + Advax-3
preS HBsAg + alum adjuvant
ACTIVE COMPARATORpreS HBsAg + alum adjuvant
preS HBsAg + Advax-1(TM)
EXPERIMENTALpreS HBsAg + Advax-1
preS HBsAg + Advax-2(TM)
EXPERIMENTALpreS HBsAg + Advax-2
preS HBsAg + Advax-3(TM)
EXPERIMENTALpreS HBsAg + Advax-3
high dose preS HBsAg + alum adjuvant
ACTIVE COMPARATORhigh dose preS HBsAg + alum adjuvant
high dose preS HBsAg + Advax-1(TM)
EXPERIMENTALhigh dose preS HBsAg + Advax-1
high dose preS HBsAg + Advax-2(TM)
EXPERIMENTALhigh dose preS HBsAg + Advax-2(TM)
high dose preS HBsAg + Advax-3(TM)
EXPERIMENTALhigh dose preS HBsAg + Advax-3
Interventions
Standard hepatitis B vaccine antigen
preS hepatitis B surface antigen
Adjuvant formulated with vaccine antigen
Adjuvant formulated with vaccine antigen
Adjuvant formulated with vaccine antigen
Adjuvant formulated with vaccine antigen
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vaxine Pty Ltdlead
- Flinders Medical Centrecollaborator
Study Sites (1)
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Barbara, MBBS PhD
Flinders Medical Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2013
First Posted
September 27, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2017
Study Completion
May 1, 2019
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
Currently no plan