Recruitment

Recruitment Status
Completed

Inclusion Criterias

Male or female
Has one or more of
Willing and able to comply with the protocol for the duration of the study.
...
Male or female
Has one or more of
Willing and able to comply with the protocol for the duration of the study.
Age 18 years and above
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)
Able to provide written informed consent

Exclusion Criterias

Any other serious medical, social or mental condition that, in the opinion of the investigator, would be detrimental to the subjects or the study.
History of serious vaccine allergy if in the opinion of the Investigator this represents a contraindication to hepatitis B vaccination
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.
History of serious vaccine allergy if in the opinion of the Investigator this represents a contraindication to hepatitis B vaccination
Participation in another clinical trial with an investigational agent within 28 days of the scheduled date of first immunization.
History of prior 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.
History of systemic autoimmune disease including Wegener's granulomatosis, systemic lupus erythematosus, Guillain-Barre, scleroderma or multiple sclerosis.
Pregnant or lactating women.

Summary

Conditions
Exposure to Hepatitis B Virus
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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

Inclusion Criterias

Male or female
Has one or more of
Willing and able to comply with the protocol for the duration of the study.
...
Male or female
Has one or more of
Willing and able to comply with the protocol for the duration of the study.
Age 18 years and above
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)
Able to provide written informed consent

Exclusion Criterias

Any other serious medical, social or mental condition that, in the opinion of the investigator, would be detrimental to the subjects or the study.
History of serious vaccine allergy if in the opinion of the Investigator this represents a contraindication to hepatitis B vaccination
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.
History of serious vaccine allergy if in the opinion of the Investigator this represents a contraindication to hepatitis B vaccination
Participation in another clinical trial with an investigational agent within 28 days of the scheduled date of first immunization.
History of prior 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.
History of systemic autoimmune disease including Wegener's granulomatosis, systemic lupus erythematosus, Guillain-Barre, scleroderma or multiple sclerosis.
Pregnant or lactating women.

Locations

Adelaide, South Australia, 5042
Adelaide, South Australia, 5042

Tracking Information

NCT #
NCT01951677
Collaborators
Flinders Medical Centre
Investigators
  • Principal Investigator: Jeffrey Barbara, MBBS PhD Flinders Medical Centre
  • Jeffrey Barbara, MBBS PhD Flinders Medical Centre