An early-stage clinical trial examining an investigational vaccination to stave off Nipah virus infection has been started by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health.
A zoonotic illness is one that can transmit from animal to human contact, such as the Nipah virus infection. The virus’s natural host is the fruit bat. The first outbreak, which happened in 1998 in Malaysia and Singapore, resulted in 265 human cases, 105 fatalities, and severe financial harm to the region’s swine economy. Annual outbreaks have been happening in Asia since 1999.
The experimental vaccine was created in cooperation with the NIAID’s Vaccine Research Center and is produced by Moderna, Inc. in Cambridge, Massachusetts. It is built on the same messenger RNA (mRNA) basis as other authorised COVID-19 vaccines. The Phase 1 clinical trial, which is being carried out at the NIH Clinical Center in Bethesda, Maryland, is being funded by NIAID.
The virus can quickly develop from signs of a respiratory infection to encephalitis (brain swelling), which can result in a coma or death. According to estimates, between 40 and 75 percent of Nipah virus victims pass away. Even though animal-to-animal transmission accounts for the majority of cases, it can also happen. A licenced vaccine or remedy for Nipah virus infection is not yet available.
The Pandemic Preparedness Plan from the NIAID, which was released early 2022, established a framework for studying viruses with pandemic potential and gave prototype pathogens like the Nipah virus top priority in research. Since the plan was published, this is the first clinical experiment utilising the prototype pathogen method.
In 40 healthy persons between the ages of 18 and 60, the investigational mRNA-1215 Nipah virus vaccine will be put to the test in a dose-escalation clinical trial to determine its safety, tolerability, and capacity to elicit an immunological response. In particular, the investigational vaccine will be administered in two doses by injection into the shoulder muscle, four or 12 weeks apart, to 4 groups of 10 people each.
Group 1 (10 participants) will receive two injections of 25 micrograms (mcg), Group 2 will receive two injections of 50 mcg, and Group 3 will receive two injections of 100 mcg, all administered four weeks apart. An interim review of the outcomes from the three prior groups will be used to establish the vaccination dose for the fourth group of participants.
The fourth group will get two injections spaced out by 12 weeks. Participants in the study will be assessed during the course of the investigation through clinical observation and blood sampling, and they will be monitored by clinical study staff for 52 weeks after receiving their final immunisation.
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 Anthony S. Fauci, M.D., NIAID Director