The National Institute of Allergy and Infectious Diseases (NIAID) which is a part of the National Institutes of Health (NIH) announced Wednesday that it has launched an early-stage clinical trial evaluating an investigational vaccine to prevent infection with the Nipah virus. Manufactured by Moderna, the experimental vaccine is was developed in collaboration with NIAID’s Vaccine Research Center.
According to reports, it is based on a messenger RNA (mRNA) platform—a technology used in several approved Covid-19 vaccines. Meanwhile, NIAID is sponsoring the phase 1 clinical study, which is being conducted at the NIH 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. Currently, there is no licensed vaccine or treatment for Nipah virus infection.
“Nipah 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. The need for a preventive Nipah virus vaccine is significant,” said NIAID director Anthony S. Fauci, M.D.
NIAID’s Pandemic Preparedness Plan, 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’s 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. Moreover, the 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 for 52 weeks following their final vaccination.
The virus can cause mild-to-severe disease rapidly progressing from respiratory infection symptoms to encephalitis (brain swelling) leading to coma or death. According to reports, an estimated 40 percent to 75 percent of people infected with the Nipah virus die.