Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40–70 years of age

Highlights • Phase 3 trial of investigational hepatitis B vaccine in adults 40–70 years old. • 2 doses of HBsAg-1018 demonstrated superior seroprotection to 3 doses of HBsAg-Eng. • HBsAg-1018 induced earlier seroprotection than HBsAg-Eng. • The safety profile of HBsAg-1018 was similar to that of HBs...

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Veröffentlicht in:	Vaccine 2013-11, Vol.31 (46), p.5300-5305
Hauptverfasser:	Heyward, William L, Kyle, Michael, Blumenau, Joseph, Davis, Matthew, Reisinger, Keith, Kabongo, Martin L, Bennett, Sean, Janssen, Robert S, Namini, Hamid, Martin, J. Tyler
Format:	Artikel
Sprache:	eng
Schlagworte:	Adjuvants, Immunologic - administration & dosage Adjuvants, Immunologic - adverse effects Adult Age Aged agonists Allergy and Immunology Applied microbiology Biological and medical sciences Compliance Double-Blind Method Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - pathology elderly Female Fundamental and applied biological sciences. Psychology Health care Healthy Volunteers Hepatitis hepatitis B Hepatitis B - prevention & control Hepatitis B Antibodies - blood hepatitis B antigens Hepatitis B Surface Antigens - administration & dosage Hepatitis B Surface Antigens - immunology Hepatitis B vaccine Hepatitis B Vaccines - administration & dosage Hepatitis B Vaccines - adverse effects Hepatitis B Vaccines - immunology Hepatitis B virus Human viral diseases Humans immune response Immunogenicity Infections Infectious diseases Licenses Male Medical sciences Microbiology Middle Aged Miscellaneous Older people Oligodeoxyribonucleotides - administration & dosage Oligodeoxyribonucleotides - adverse effects people Population Public health Randomized trial Safety Toll-like receptor 9 Toll-Like Receptor 9 - agonists Toll-like receptor 9 agonist Vaccination - methods Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Viral diseases Viral hepatitis Virology
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Beschreibung
Zusammenfassung:	Highlights • Phase 3 trial of investigational hepatitis B vaccine in adults 40–70 years old. • 2 doses of HBsAg-1018 demonstrated superior seroprotection to 3 doses of HBsAg-Eng. • HBsAg-1018 induced earlier seroprotection than HBsAg-Eng. • The safety profile of HBsAg-1018 was similar to that of HBsAg-Eng.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2013.05.068