A controlled clinical trial comparing the safety and immunogenicity of a new adjuvanted hepatitis B vaccine with a standard hepatitis B vaccine |
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| Authors: | Dupont Juan Altclas Javier Lepetic Alejandro Lombardo Mónica Vázquez Vicente Salgueira Claudia Seigelchifer Mauricio Arndtz Nathaly Antunez Ernesto von Eschen Kenneth Janowicz Zbigniew |
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| Affiliation: | 1. Department of Haematology, Hospital Español, Buenos Aires, Argentina;2. Department of Infectious Diseases, Instituto Médico Antártida, Buenos Aires, Argentina;3. Fundación del Centro de Estudios Infectológicos (FUNCEI), Buenos Aires, Argentina;4. CTCRO, Solver Group, Buenos Aires, Argentina;5. PC-Gen SA, Buenos Aires, Argentina;6. Corixa Corporation, Seattle, WA, USA;7. Rhein Biotech GmbH, Eichsfelder Str. 11, 40595 Düsseldorf, Germany;1. Gene Therapy Program, Department of Medicine, NorthShore Research Institute, Evanston, Illinois, USA;2. Gene Therapy Program, Department of Surgery, NorthShore Research Institute, Evanston, Illinois, USA;3. Gene Therapy Program, Department of Pathology, NorthShore Research Institute, Evanston, Illinois, USA;4. Image Processing Lab, Center for Advanced Imaging, Department of Radiology, NorthShore Research Institute, Evanston, Illinois, USA;5. Advanced Photon Source, Argonne National Laboratory, Argonne, Illinois, USA;6. Department of Molecular Pharmacology and Biological Chemistry, Northwestern University, Chicago, Illinois, USA;7. Department of Medicine, Indiana University, Indianapolis, Indiana, USA;8. Department of Microbiology and Immunology, University of Illinois, Chicago, Illinois, USA;1. Centre for Genomics & Child Health, Blizard Institute, Queen Mary University of London, London, UK;2. Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe;3. Department of Infectious Disease Epidemiology, St Mary''s Campus, Imperial College London, London, UK;4. Department of Microbiology and Molecular Genetics, Vaccine Testing Center, University of Vermont College of Medicine, Burlington, VT, USA;1. Apicore Pharmaceuticals Pvt. Ltd, Block No. 252-253, Dhobikuva Village, Padra-Jambusar Highway, Padra Taluka, Vadodara 391 440, India;2. Department of Chemistry, Amet University, 135, East Coast Road, Kanathur, Chennai 603 112, India;3. Department of Chemistry, Faculty of Science, M. S. University of Baroda, Vadodara 390 002, India |
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| Abstract: | A randomised trial was conducted in 285 adults not immune to hepatitis B (HB) to compare the safety and immunogenicity of a commercial aluminium-adjuvanted HB vaccine with and without an additional new adjuvant (AgB/RC-210-04 or AgB study groups, respectively). The additional adjuvant RC-529 is a fully synthetic monosaccharide mimetic of monophosphoryl lipid A. Subjects in the AgB/RC-210-04 (n=136) and AgB (n=149) groups were vaccinated intramuscularly on days 0, 30, and 180, according to the standard vaccination schedule for hepatitis B vaccines. Serum levels of anti-HBs were measured on days 30, 60, 90, 180, and 210. Standard safety assessments were made throughout the study period. The rates of seroprotection (anti-HBs > or =10.0 mIU/ml) were significantly greater for the AgB/RC-210-04 group at all time points: at day 90, the seroprotection rate, the primary endpoint of the trial, was 99% for AgB/RC-210-04 compared with 84% for AgB (p<0.0001). Similarly, geometric mean anti-HBs titres were significantly higher at all time points for the AgB/RC-210-04 group. There were more local reactions in the AgB/RC-210-04 group, however they were transient and this double-adjuvanted formulation was well tolerated. We conclude that the addition of a synthetic adjuvant to the AgB vaccine significantly enhanced the immunogenicity of the commercial vaccine AgB. The results indicate furthermore that a two-dose regime of the double-adjuvanted vaccine (schedule: 0-1 month) may be sufficient to achieve seroprotection in nearly 100% of individuals. |
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| Keywords: | Hepatitis B Adjuvant Vaccines |
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