Randomized,single-blind,active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose,quadrivalent influenza vaccine) in healthy adults |
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| Institution: | 1. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea;2. Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea;1. Departments of Pediatrics, Baylor College of Medicine, Houston, TX, United States;2. Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States;3. Medicine, Baylor College of Medicine, Houston, TX, United States;4. Department of Pediatrics and Medicine, Emory University School of Medicine, Atlanta, GA, United States;5. Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States;6. Department of Pediatrics, Children’s Mercy Hospital Kansas City, Kansas City, MO, United States;7. Department of Pediatrics, Saint Louis University School of Medicine, St. Louis, MO, United States;8. Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, United States;9. Department of Pediatrics and Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, United States;10. Department of Pediatrics, Duke University School of Medicine, Durham, NC, United States;11. The Emmes Corporation, Rockville, MD, United States;12. National Institute of Allergy and Infectious Diseases, Rockville, MD, United States;1. Centre for Medical Parasitology at Department of International Health, Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark;2. Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;3. Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark;4. LIONEX Diagnostics & Therapeutics GmbH, 38126 Braunschweig, Germany;5. Centre National de Recherche et de Formation sur le Paludisme, BP 2208, Ouagadougou 01, Burkina Faso;6. ASAREN 01BP3916, Ouagadougou 01, Burkina Faso;7. Institut Pasteur, 28 rue du Dr Roux, 75015 Paris, France;8. Biochemistry Department, University of Lausanne, 1066 Epalinges, Switzerland;1. Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, 1100 S. Grand Boulevard, St. Louis, MO 63104, USA;2. University of Rochester School of Medicine, Rochester General Hospital, Rochester, NY 14621, USA;3. Sanofi Pasteur, Inc., 1 Discovery Drive, Swiftwater, PA 18370, USA;1. Division of Pediatric Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA;2. Clinical Development, Seqirus Pty Ltd, Parkville, Victoria, Australia;3. Global Pharmacovigilance and Risk Management, Seqirus Pty Ltd, Parkville, Victoria, Australia;4. Clinical Development, Seqirus Netherlands B.V., Amsterdam, The Netherlands;5. Clinical Development, Seqirus USA Inc., Cambridge, MA, USA;1. Department of Virology, Institute of Experimental Medicine, 197376 St Petersburg, Russia;2. Department of Molecular Virology, Institute of Influenza, 197376 St Petersburg, Russia;3. Department of Epidemiology and Prophylaxis, Institute of Influenza, 197376 St Petersburg, Russia;4. Department of Biotechnology, Institute of Influenza, 197376 St Petersburg, Russia;5. PATH, Seattle, WA 98121, USA |
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| Abstract: | Influenza is a major medically attended respiratory illness. The impact of influenza on morbidity and mortality is particularly high in the elderly. Immunosenescence attenuates the immune response of influenza vaccine in the elderly. High-dose influenza vaccine contains 60 μg of hemagglutinin per strain, four times more compared with standard-dose (SD) influenza vaccine. This study is a phase I clinical trial investigating the immunogenicity and safety of the GC3114, high-dose, quadrivalent inactivated influenza vaccine (HD-QIV) in healthy adults aged 19–64 years during the 2017–2018 season. Seroprotection rates of HD-QIV were 100.0% for A/H1N1, 96.67% for A/H3N2, 83.33% for B/Yamagata, and 96.67% for B/Victoria. Seroconversion rate for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 86.67%, 90.0%, 53.33%, and 53.33%, respectively, in the HD-QIV group. The post-/pre-vaccination geometric mean titer ratio (GMTR) was 15.28 for A/H1N1, 8.19 for A/H3N2, 3.56 for B/Yamagata, and 3.03 for B/Victoria in the HD-QIV group. Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control). No serious adverse events were reported. In conclusion, GC3114 was safe, well-tolerated, and immunogenic in healthy adults. Clinical Trials Identifier: NCT03357263. |
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| Keywords: | Influenza human Influenza vaccines Frail elderly |
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