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News Release
Monday, July 11, 2022
四虎影院launches clinical trial of mRNA Nipah virus vaccine
The National Institute of Allergy and Infectious Diseases (NIAID), part of the 四虎影院, has launched an early-stage clinical trial evaluating an investigational vaccine to prevent infection with Nipah virus. The experimental vaccine is manufactured by Moderna, Inc., Cambridge, Massachusetts, and was developed in collaboration with 狈滨础滨顿鈥檚 Vaccine Research Center. It is based on a messenger RNA (mRNA) platform鈥攁 technology used in several approved COVID-19 vaccines. NIAID is sponsoring the Phase 1 clinical study, which is being conducted at the 四虎影院Clinical Center in Bethesda, Maryland.
Nipah virus infection is a zoonotic disease, meaning that it is spread between animals and people. Fruit bats are the natural host for the virus. The first known Nipah outbreak occurred in 1998 in Malaysia and Singapore and resulted in 265 human cases and 105 deaths, and caused significant economic damage to the swine industry there. Since 1999, outbreaks have occurred annually in Asia, primarily in Bangladesh and India. The virus can cause mild-to-severe disease rapidly progressing from respiratory infection symptoms to encephalitis (brain swelling) leading to coma or death. An estimated 40% to 75% of people infected with Nipah virus die. Although most cases are transmitted via animals, person-to-person transmission can occur. Currently, there is no licensed vaccine or treatment for Nipah virus infection.
鈥淣ipah virus poses a considerable pandemic threat because it mutates relatively easily, causes disease in a wide range of mammals, can transmit from person-to-person, and kills a large percentage of the people it infects,鈥 said NIAID Director Anthony S. Fauci, M.D. 鈥淭he need for a preventive Nipah virus vaccine is significant.鈥
狈滨础滨顿鈥檚 , published earlier this year, established a framework to study viruses of pandemic potential and prioritize research on prototype pathogens, such as Nipah virus. This is the first clinical trial using the prototype pathogen approach since the plan鈥檚 publication.
The experimental mRNA-1215 Nipah virus vaccine will be tested in a dose-escalation clinical trial to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults ages 18 to 60 years. Specifically, four groups of 10 participants each will receive two doses of the investigational vaccine via injection in the shoulder muscle four or 12 weeks apart. Group one (10 participants) will receive two 25-microgram (mcg) injections; group two will receive two 50-mcg injections; and group three will receive two 100-mcg injections, each four weeks apart. The vaccine dose for the fourth group of participants will be determined based on an interim analysis of the results from the three previous groups. The fourth group will receive two injections 12 weeks apart. Study participants will be evaluated through clinical observation and blood collection at specified times throughout the study and will be followed by clinical study staff through 52 weeks following their final vaccination.
For more information about the clinical trial, visit ClinicalTrials.gov using the study identifier .
NIAID conducts and supports research鈥攁t NIH, throughout the United States, and worldwide鈥攖o study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the .
About the 四虎影院 (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. 四虎影院is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about 四虎影院and its programs, visit www.nih.gov.
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