Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04
The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers ≥15 years of age. A total of 1303 subjects were enrolled to receive either two doses o...
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| Published in | Vaccine Vol. 23; no. 3; pp. 316 - 320 |
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| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford
Elsevier Ltd
02.12.2004
Elsevier Elsevier Limited |
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| Abstract | The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers ≥15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine. |
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| AbstractList | The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers >or=15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine. The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers ≥15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine. The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers >or=15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine. The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers >=15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine. |
| Author | Steffen, R. Boland, G. Lievens, M. Stoffel, M. Dentico, P. Sasadeusz, J. Zuckerman, J.N. Loutan, L. Genton, B. Beran, J. Nothdurft, H. Hattum, J. Van |
| Author_xml | – sequence: 1 givenname: G. surname: Boland fullname: Boland, G. organization: Department of Gastroenterology, Universitair Medisch Centrum Utrecht, PB85500, 3508 GA Utrecht, The Netherlands – sequence: 2 givenname: J. surname: Beran fullname: Beran, J. organization: Vaccination and Travel Medicine Centre, Poliklinika II, Hradec Kralove, Czech Republic – sequence: 3 givenname: M. surname: Lievens fullname: Lievens, M. organization: GSK Biologicals, 89 Rue de l’Institut, 1330 Rixensart, Belgium – sequence: 4 givenname: J. surname: Sasadeusz fullname: Sasadeusz, J. organization: Victorian Infectious Diseases Service, Grattan Street, Parkville, Vic. 3050, Australia – sequence: 5 givenname: P. surname: Dentico fullname: Dentico, P. organization: Cattedra Malattie Tropicali, Istituto Policattedra di Clinica Medica e Malattie Infettive, Universita degli Studi Bari, Piazza Giulio Cesare, 1170124 Bari, Italy – sequence: 6 givenname: H. surname: Nothdurft fullname: Nothdurft, H. organization: Institute of Tropical Medicine, University of Munich, Leopoldstraße 5, D-80802 Munich, Germany – sequence: 7 givenname: J.N. surname: Zuckerman fullname: Zuckerman, J.N. organization: Academic Centre for Travel Medicine and Vaccines, Royal Free and University College Medical School, Rowland Hill Street, London NW32PF, UK – sequence: 8 givenname: B. surname: Genton fullname: Genton, B. organization: Policlinique Médicale Universitaire, Rue du Bugnon 44, 1011 Lausanne, Switzerland – sequence: 9 givenname: R. surname: Steffen fullname: Steffen, R. organization: Institute of Social and Preventive Medicine, University of Zurich, Sumatrastr 30, 8006 Zurich, Switzerland – sequence: 10 givenname: L. surname: Loutan fullname: Loutan, L. organization: Unité de Médecine des Voyages et des Migrations, Hôpitaux Universitaires de Genève, Rue Micheli-du-Crest 24, 1211 Geneva 14, Switzerland – sequence: 11 givenname: J. Van surname: Hattum fullname: Hattum, J. Van organization: Department of Gastroenterology, Universitair Medisch Centrum Utrecht, PB85500, 3508 GA Utrecht, The Netherlands – sequence: 12 givenname: M. surname: Stoffel fullname: Stoffel, M. email: michel.stoffel@gskbio.com organization: GSK Biologicals, 89 Rue de l’Institut, 1330 Rixensart, Belgium |
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| Cites_doi | 10.1016/S0264-410X(97)00254-5 10.1097/00001432-200210000-00002 10.1016/S0264-410X(02)00636-9 10.1016/0264-410X(95)00011-O 10.1016/S0264-410X(99)00566-6 10.1080/00365540110080881 10.1016/S0264-410X(00)00462-X 10.1016/S0264-410X(02)00150-0 |
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| Keywords | Hepatitis B vaccine Adjuvant AS04 Safety Infection Viral hepatitis B Immunogenicity Toxicity Viral disease Immunological adjuvant Digestive diseases Hepatic disease Vaccine |
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J. Infect. Dis. doi: 10.1080/00365540110080881 contributor: fullname: Levie – volume: 19 start-page: 2400 year: 2001 ident: 10.1016/j.vaccine.2004.06.006_bib8 article-title: A prophylactic hepatitis B vaccine with a novel adjuvant system publication-title: Vaccine doi: 10.1016/S0264-410X(00)00462-X contributor: fullname: Thoelen – start-page: 145 year: 1990 ident: 10.1016/j.vaccine.2004.06.006_bib7 article-title: A critical determinant of lipid A endotoxic activity contributor: fullname: Myers – volume: 20 start-page: 2597 year: 2002 ident: 10.1016/j.vaccine.2004.06.006_bib13 article-title: HLA DQ2 positive subjects vaccinated with HB-AS04, a hepatitis B vaccine with a novel adjuvant publication-title: Vaccine doi: 10.1016/S0264-410X(02)00150-0 contributor: fullname: Desombere – volume: 388 start-page: 107 year: 1994 ident: 10.1016/j.vaccine.2004.06.006_bib5 article-title: Prophylactic use of mono-phosphoryl lipid A in patients at risk for sepsis publication-title: Prog. Clin. Biol. Res. contributor: fullname: Rudbach – ident: 10.1016/j.vaccine.2004.06.006_bib9 – ident: 10.1016/j.vaccine.2004.06.006_bib6 – volume: 5 start-page: 4 year: 2000 ident: 10.1016/j.vaccine.2004.06.006_bib14 article-title: Immunogenicity and reactogenicity of the novel adjuvanted hepatitis B vaccine (HBsAg/SBAS4), compared to that of Engerix-B™ in older adults aged 50–70 years publication-title: Antiviral Ther. contributor: fullname: Van Herck |
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| SubjectTerms | Adjuvant AS04 Adjuvants, Immunologic - adverse effects Adolescent Adult Aged Antigens Applied microbiology Biological and medical sciences Female Fever Fundamental and applied biological sciences. Psychology Hepatitis Hepatitis B - immunology Hepatitis B Antibodies - biosynthesis Hepatitis B Antibodies - blood Hepatitis B vaccine Hepatitis B Vaccines - adverse effects Hepatitis B Vaccines - immunology Human viral diseases Humans Immunogenicity Infections Infectious diseases Laboratories Lipids Male Medical sciences Microbiology Middle Aged Pain Prospective Studies Radioimmunoassay Safety Single-Blind Method Studies Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Viral diseases Viral hepatitis Viral infections |
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| Title | Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04 |
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