Immunogenicity and safety of Advax™, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface antigen: A randomized controlled Phase 1 study

•Phase 1 first-in-man study of HBV vaccine based on Advax, a novel delta inulin-based adjuvant.•Advax enhanced both humoral and cellular immune responses to HBsAg.•Advax was safe and well tolerated in human subjects. There is a need for additional safe and effective human vaccine adjuvants. Advax™ i...

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Published inVaccine Vol. 32; no. 48; pp. 6469 - 6477
Main Authors Gordon, David, Kelley, Peter, Heinzel, Susanne, Cooper, Peter, Petrovsky, Nikolai
Format Journal Article
LanguageEnglish
Published Kidlington Elsevier Ltd 12.11.2014
Elsevier
Elsevier Limited
Subjects
Adjuvant
Adjuvants, Immunologic - administration & dosage
Adult
adults
Advax
Allergy and Immunology
alum
Antibodies, Viral - blood
Antigens
Applied microbiology
Australia
Biological and medical sciences
CD4-positive T-lymphocytes
CD4-Positive T-Lymphocytes - immunology
cell-mediated immunity
Clinical trial
Clinical trials
Delta inulin
Diabetes
Female
Fundamental and applied biological sciences. Psychology
Hepatitis
Hepatitis B
Hepatitis B - prevention & control
hepatitis B antigens
Hepatitis B Surface Antigens - immunology
Hepatitis B Vaccines - therapeutic use
Hepatitis B virus
HIV
Human
Human immunodeficiency virus
Human viral diseases
Humans
immune response
Immunogenicity
Infections
Infectious diseases
injection site
inulin
Inulin - administration & dosage
Inulin - analogs & derivatives
Liver
Male
Medical sciences
Microbiology
Miscellaneous
New Zealand
pain
Phase 1
Safety
Single-Blind Method
Studies
Vaccine
vaccine adjuvants
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Viral diseases
Viral hepatitis
Virology
West Nile virus
Young Adult
Australia
New Zealand
Human
Clinical trial
Advax
Vaccine
Adjuvant
Delta inulin
Phase 1
Hepatitis B
Hepatitis B surface antigen
Orthohepadnavirus
Hepatic disease
Infection
Virus
Viral hepatitis B
Immunogenicity
Hepadnaviridae
Viral disease
Immunological adjuvant
Viral hepatitis delta
Inulin
Digestive diseases
Hepatitis B virus
Prebiotic
Polysaccharide
Online AccessGet full text

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Abstract •Phase 1 first-in-man study of HBV vaccine based on Advax, a novel delta inulin-based adjuvant.•Advax enhanced both humoral and cellular immune responses to HBsAg.•Advax was safe and well tolerated in human subjects. There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9–139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0–266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3–12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.
AbstractList •Phase 1 first-in-man study of HBV vaccine based on Advax, a novel delta inulin-based adjuvant.•Advax enhanced both humoral and cellular immune responses to HBsAg.•Advax was safe and well tolerated in human subjects. There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9–139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0–266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3–12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.
There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9–139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0–266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3–12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.
There is a need for additional safe and effective human vaccine adjuvants. Advax(TM) is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9-139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0-266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3-12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.
There is a need for additional safe and effective human vaccine adjuvants. Advax is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9–139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0–266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3–12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482
There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9-139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0-266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3-12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9-139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0-266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3-12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.
Highlights•Phase 1 first-in-man study of HBV vaccine based on Advax, a novel delta inulin-based adjuvant. •Advax enhanced both humoral and cellular immune responses to HBsAg. •Advax was safe and well tolerated in human subjects.
Author Heinzel, Susanne
Kelley, Peter
Cooper, Peter
Gordon, David
Petrovsky, Nikolai
AuthorAffiliation 2 Vaxine Pty Ltd, Bedford Park, Adelaide, Australia 5042
3 Department of Endocrinology, Flinders Medical Centre/Flinders University, Adelaide, Australia 5042
1 Department of Microbiology and Infectious Diseases, Flinders Medical Centre/Flinders University, Adelaide, Australia 5042
4 Cancer Research Laboratory, Australian National University Medical School at The Canberra Hospital, Garran, ACT, Australia 2605; and John Curtin School of Medical Research, Australian National University, Acton, ACT, Australia 2601
AuthorAffiliation_xml – name: 4 Cancer Research Laboratory, Australian National University Medical School at The Canberra Hospital, Garran, ACT, Australia 2605; and John Curtin School of Medical Research, Australian National University, Acton, ACT, Australia 2601
– name: 1 Department of Microbiology and Infectious Diseases, Flinders Medical Centre/Flinders University, Adelaide, Australia 5042
– name: 3 Department of Endocrinology, Flinders Medical Centre/Flinders University, Adelaide, Australia 5042
– name: 2 Vaxine Pty Ltd, Bedford Park, Adelaide, Australia 5042
Author_xml – sequence: 1
  givenname: David
  orcidid: 0000-0003-3276-9685
  surname: Gordon
  fullname: Gordon, David
  organization: Department of Microbiology and Infectious Diseases, Flinders Medical Centre/Flinders University, Adelaide 5042, Australia
– sequence: 2
  givenname: Peter
  surname: Kelley
  fullname: Kelley, Peter
  organization: Department of Microbiology and Infectious Diseases, Flinders Medical Centre/Flinders University, Adelaide 5042, Australia
– sequence: 3
  givenname: Susanne
  surname: Heinzel
  fullname: Heinzel, Susanne
  organization: Vaxine Pty Ltd, Bedford Park, Adelaide 5042, Australia
– sequence: 4
  givenname: Peter
  surname: Cooper
  fullname: Cooper, Peter
  organization: Vaxine Pty Ltd, Bedford Park, Adelaide 5042, Australia
– sequence: 5
  givenname: Nikolai
  orcidid: 0000-0002-1580-5245
  surname: Petrovsky
  fullname: Petrovsky, Nikolai
  email: nikolai.petrovsky@flinders.edu.au
  organization: Vaxine Pty Ltd, Bedford Park, Adelaide 5042, Australia
BackLink http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28928756$$DView record in Pascal Francis
https://www.ncbi.nlm.nih.gov/pubmed/25267153$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright 2014 Elsevier Ltd
Elsevier Ltd
2015 INIST-CNRS
Copyright © 2014 Elsevier Ltd. All rights reserved.
Copyright Elsevier Limited Nov 12, 2014
2014 Elsevier Ltd. All rights reserved. 2014
Copyright_xml – notice: 2014 Elsevier Ltd
– notice: Elsevier Ltd
– notice: 2015 INIST-CNRS
– notice: Copyright © 2014 Elsevier Ltd. All rights reserved.
– notice: Copyright Elsevier Limited Nov 12, 2014
– notice: 2014 Elsevier Ltd. All rights reserved. 2014
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IsPeerReviewed true
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Issue 48
Keywords Human
Clinical trial
Advax
Vaccine
Adjuvant
Delta inulin
Phase 1
Hepatitis B
Hepatitis B surface antigen
Orthohepadnavirus
Hepatic disease
Infection
Virus
Viral hepatitis B
Immunogenicity
Hepadnaviridae
Viral disease
Immunological adjuvant
Viral hepatitis delta
Inulin
Digestive diseases
Hepatitis B virus
Prebiotic
Polysaccharide
Language English
License CC BY 4.0
Copyright © 2014 Elsevier Ltd. All rights reserved.
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Snippet •Phase 1 first-in-man study of HBV vaccine based on Advax, a novel delta inulin-based adjuvant.•Advax enhanced both humoral and cellular immune responses to...
Highlights•Phase 1 first-in-man study of HBV vaccine based on Advax, a novel delta inulin-based adjuvant. •Advax enhanced both humoral and cellular immune...
There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin....
There is a need for additional safe and effective human vaccine adjuvants. Advax(TM) is a novel adjuvant produced from semi-crystalline particles of delta...
There is a need for additional safe and effective human vaccine adjuvants. Advax is a novel adjuvant produced from semi-crystalline particles of delta inulin....
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SubjectTerms Adjuvant
Adjuvants, Immunologic - administration & dosage
Adult
adults
Advax
Allergy and Immunology
alum
Antibodies, Viral - blood
Antigens
Applied microbiology
Australia
Biological and medical sciences
CD4-positive T-lymphocytes
CD4-Positive T-Lymphocytes - immunology
cell-mediated immunity
Clinical trial
Clinical trials
Delta inulin
Diabetes
Female
Fundamental and applied biological sciences. Psychology
Hepatitis
Hepatitis B
Hepatitis B - prevention & control
hepatitis B antigens
Hepatitis B Surface Antigens - immunology
Hepatitis B Vaccines - therapeutic use
Hepatitis B virus
HIV
Human
Human immunodeficiency virus
Human viral diseases
Humans
immune response
Immunogenicity
Infections
Infectious diseases
injection site
inulin
Inulin - administration & dosage
Inulin - analogs & derivatives
Liver
Male
Medical sciences
Microbiology
Miscellaneous
New Zealand
pain
Phase 1
Safety
Single-Blind Method
Studies
Vaccine
vaccine adjuvants
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Viral diseases
Viral hepatitis
Virology
West Nile virus
Young Adult
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Title Immunogenicity and safety of Advax™, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface antigen: A randomized controlled Phase 1 study
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Volume 32
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