Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized,single-blind,placebo controlled phase II clinical study |
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Institution: | 1. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;2. Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea;3. Division of High-risk Pathogens, Center for Laboratory Control of Infectious Diseases, Korea Centers for Disease Control and Prevention, Chungju, Republic of Korea;4. GC Pharma Central Research Center, Yongin, Republic of Korea;1. Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, United States;2. Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, United States;3. Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States;4. Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, United States;5. Department of Medicine, University of Tennessee Health Science Center, Saint Thomas Health, Nashville, TN, United States;6. Department of Health Policy, Vanderbilt University Medical Center, Nashville, TN, United States;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. Animal and Plant Quarantine Agency, Gimcheon, Gyeonsangbuk-do 39660, Republic of Korea;2. Median Diagnostics, Chuncheon, Kangwon-do 24399, Republic of Korea;3. College of Veterinary Medicine & Animal Disease Intervention Center, Kyungpook National University, Daegu 41566, Republic of Korea;1. Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;2. Department of Emergency Medicine, Seoul National University College of Medicine, Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute, Seoul, Republic of Korea;3. Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute, Seoul, Republic of Korea;4. Department of Emergency Medicine, Seoul National University College of Medicine, Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute, Seoul, Republic of Korea;5. Department of Emergency Medicine, Seoul National University Boramae Medical Center, Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute, Seoul, Republic of Korea;6. Department of Emergency Medicine, Seoul National University Bundang Hospital, Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute, Seoul, Republic of Korea;7. Department of Emergency Medicine, Seoul National University College of Medicine, Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute, Seoul, Republic of Korea |
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Abstract: | BackgroundThe demand on effective and safe anthrax vaccine is increasing as a part of the preparedness for possible bioterrorism in the future. We performed a randomized, single-blind, placebo controlled phase II clinical study to evaluate the immunogenicity and safety of a novel recombinant protective antigen (rPA) anthrax vaccine, GC1109, in healthy adult volunteers.MethodsParticipants were randomized to experiment groups (0.3 mL, 0.5 mL, and 1.0 mL of GC1109) or placebo group (normal saline 0.5 mL) in 2:2:2:1 ratio. They received respective vaccines intramuscularly at 0, 4 and 8 weeks. Immunogenicity was evaluated by seroconversion rate and geometric mean titer (GMT) of lethal toxin neutralizing assay (TNA) and anti-PA IgG by ELISA. Safety was assessed by laboratory tests, and solicited and unsolicited adverse events on diary cards.Results30, 29, 30 participants were randomized to 0.3, 0.5, and 1.0 mL of GC1109 groups, respectively, while 15 to placebo group. 92 participants received all three doses. In per-protocol analysis, TNA GMTs at week 12 were 296.5, 285.2, and 433.2 in the three groups, respectively. Seroconversion rates measured by ELISA were 100% at week 12 in the three groups. Local and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed.ConclusionsA new rPA anthrax vaccine GC1109 was immunogenic after three doses of intramuscular administration, and was well-tolerated. |
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Keywords: | Recombinant protective antigen anthrax vaccine Immunogenicity Safety |
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