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Use of controlled human infection models (CHIMs) to support vaccine development: US regulatory considerations
Affiliation:1. Division of Infectious Diseases, Brigham and Women’s Hospital, Boston, MA, USA;2. Department of Microbiology, Harvard Medical School, Boston, MA, USA;3. Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, MA, USA;4. Howard Hughes Medical Institute, Bethesda, MD, USA;1. Department of Respiratory Medicine, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan;2. Gunma Prefectural Institute of Public Health and Environmental Science, 378 Kamioki-machi, Maebashi-shi, Gunma 371-0052, Japan;3. Department of Microbiology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa 236-0004, Japan;4. Takasaki City Health Center, 5-28 Takamatsu-cho, Takasaki-shi, Gunma 370-0829, Japan;5. Pathogen Genomics Center, National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan;6. Infectious Disease Surveillance Center, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama-shi, Tokyo 208-0011, Japan;1. Meridian Clinical Research, Omaha, NE, USA;2. Benchmark Research, Austin, TX, USA;3. Benchmark Research, Fort Worth, TX, USA;4. Ponce Health Sciences University, CAIMED Center, Ponce, Puerto Rico;5. Moderna, Cambridge, MA, USA
Abstract:In 2016, the United States (U.S.) Food and Drug Administration (FDA) licensed Vaxchora® for active immunization against disease caused by Vibrio cholerae serogroup 01 in adults. Vaxchora was the first US-licensed vaccine for which the primary evidence supporting effectiveness was derived from human challenge studies. Following this precedent, FDA has received numerous inquiries from manufacturers, academic researchers, funders and other stakeholders regarding how controlled human infection models (CHIMs) can be used to support the development of safe and effective vaccines to address public health needs. The aims of this article are to discuss: (1) Chemistry, Manufacturing and Controls (CMC) for challenge inocula, (2) conduct of controlled human infection studies under US IND and (3) use of CHIMs to support vaccine development. General concepts and regulatory considerations for the safe conduct of CHIMs and use of CHIMs to evaluate vaccine effectiveness are discussed.
Keywords:Regulation  Controlled human infection models  Vaccine  Clinical development  Vaccine licensure
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