Immunogenicity and safety of a modified three-dose priming and booster schedule for the Hantaan virus vaccine (Hantavax): A multi-center phase III clinical trial in healthy adults |
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| Affiliation: | 1. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea;2. Division of Infectious Diseases, Chungbuk National University College of Medicine, Cheongju, Chungcheongbuk-do, Republic of Korea;3. Division of Nephrology, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Gangwon-do, Republic of Korea;4. Division of Infectious Disease, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea;5. Division of Infectious Diseases, Department of Internal Medicine, Dongtan Sacred Heart Hospital , Hallym University College of Medicine, Hwasung, Republic of Korea;6. Department of Microbiology, Institute for Viral Diseases, Korea University College of Medicine, Seoul, Republic of Korea;1. The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan;2. Department of Nursing, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan;3. Department of Pediatrics, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan;4. Department of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan;5. Mine Pediatric Clinic, Saitama, Japan;6. Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Tokyo, Japan;7. Division of Infectious Diseases, National Center for Child Health and Development, Tokyo, Japan;8. Department of Infectious Diseases, Medical Mycology Research Center, Chiba University, Chiba, Japan;9. Department of Neonatology, Japanese Red Cross Nagoya Daiichi Hospital, Aichi, Japan;10. Department of Pediatric Neurology, Fukuoka Children''s Hospital, Fukuoka, Japan;11. Infectious Disease Center and Department of Clinical Research, National Hospital Organization Mie Hospital, Mie, Japan;12. Department of Pediatrics, Sapporo Medical University School of Medicine, Hokkaido, Japan;13. Fujioka Pediatrics, Osaka, Japan;14. Fukuoka Welfare Center for the Disabled, Fukuoka, Japan;15. Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan;p. Department of Pediatrics, University Faculty of Medicine, Oita, Japan;q. Department of Pediatrics, Kawasaki Medical School, Okayama, Japan;r. Department of Pediatrics, Fujita Health University School of Medicine, Aichi, Japan;s. Department of Infectious Diseases, Keio University School of Medicine, Tokyo, Japan;t. Department of Pediatrics, University of Occupational and Environmental Health, Fukuoka, Japan;u. Department of Pediatrics, Asahikawa Medical University, Hokkaido, Japan;v. Department of Pediatrics, Nagasaki University, Nagasaki, Japan;w. Kawasaki City Institute for Public Health, Kanagawa, Japan;x. Department of Pediatrics, Fukushima Medical University, Fukushima, Japan;y. Division of Basic Nursing, Fukuoka Nursing College, Fukuoka, Japan;1. Public Health Consultant, United States;2. National School of Tropical Medicine, Departments of Pediatrics, Molecular Virology & Microbiology, Co-Head, Section of Pediatric Tropical Medicine, Health Policy Scholar, Baylor College of Medicine, United States;1. Mayo Clinic Vaccine Research Group, Mayo Clinic, Rochester, MN, USA;2. Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA;1. Clinical microbiology, Department of Translational Medicine, Faculty of Medicine, Lund university, Jan Waldenströms gata 59, SE-205 02 Malmö, Sweden;2. ORL-department, Hospital Josina Machel, Luanda, Angola;3. Faculty of Medicine, Agostinho Neto University, Luanda, Angola;4. Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark;5. Children’s Hospital, Helsinki University Hospital, Helsinki, Finland;6. University of Helsinki, Helsinki, Finland;7. ENT-Outpatient Department, Slottsstadens Läkarhus, Malmö, Sweden |
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| Abstract: | BackgroundHemorrhagic fever with renal syndrome is a serious health problem in Eurasian countries. This study aimed to evaluate the immunogenicity and safety of formalin-inactivated Hantaan virus vaccine (Hantavax®) with a 3 + 1 vaccination schedule.MethodsA phase III, multi-center clinical trial was conducted to evaluate the immunogenicity and safety of Hantavax® (three primary doses and a booster dose schedule at 0, 1, 2 and 13 months) among healthy adults. Immune responses were assessed using the plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA). Systemic and local adverse events were assessed.ResultsA total of 320 healthy subjects aged ≥19 years were enrolled. Following three primary doses of Hantavax®, the seroconversion rate was 80.97% and 92.81% by PRNT and IFA, respectively. With booster administration, seropositive rates were 67.47% and 95.68% at one-month post-vaccination according to PRNT and IFA, respectively. Solicited local and systemic adverse events were reported in 30.50–42.81% and 16.67–33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses. Both local and systemic adverse events did not increase with repeated vaccinations.ConclusionHantavax® showed a high seroconversion rate after the three-dose priming, and additional dose administration with 11-month interval induced good booster effects. (ClinicalTrials.gov Identifier: NCT02553837). |
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| Keywords: | Hantaan virus Hantavirus Vaccine Immunogenicity Safety |
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