NIH launches clinical trial of Nipah mRNA virus vaccine

image: Color transmission electron micrograph of mature extracellular Nipah Virus particles (red) near the periphery of infected VERO cells (green).
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Credit: NIAID

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched an early-stage clinical trial evaluating the vaccine being studied to prevent Nipah virus infection. The experimental vaccine was manufactured by Moderna, Inc., (Cambridge, Massachusetts) and developed in collaboration with the NIAID Vaccine Research Center. It is based on platform messenger RNA (mRNA)—the technology used in several approved COVID-19 vaccines. 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 transmitted between animals and humans. Fruit bats are the natural hosts of this 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 pig industry there. Since 1999, outbreaks have occurred annually in Asia, especially in Bangladesh and India. This virus can cause mild to severe illness that progresses rapidly from symptoms of a respiratory infection to encephalitis (swelling of the brain) leading to coma or death. It is estimated that 40 to 75 percent of people infected with the Nipah virus die. Although most cases are transmitted through animals, person-to-person transmission can occur. Currently, there is no vaccine or licensed treatment for Nipah virus infection.

“Nipah virus poses a sizable pandemic threat because it is relatively easy to mutate, causes disease in various mammals, can be transmitted from person to person, and kills most of the people who are infected,” said NIAID Director Anthony S. Fauci, MD. Nipah virus is very important.”

The NIAID Pandemic Preparedness Plan, published earlier this year, establishes a framework for studying viruses that have the potential to become a pandemic and prioritizes research on prototype pathogens, such as the Nipah virus. This is the first clinical trial using the pathogen prototype approach since the publication of the plan.

The experimental Nipah mRNA-1215 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 aged 18 to 60 years. Specifically, the 4 groups of 10 participants will each receive two doses of the studied vaccine via injection in the shoulder muscle four or 12 weeks apart. Group 1 (10 participants) will receive two injections of 25 micrograms (mcg); group 2 will receive two 50 mcg injections; and group 3 will receive two injections of 100 mcg, four weeks apart each. Vaccine doses for the fourth group of participants will be determined based on an interim analysis of the results of the previous three groups. The fourth group will receive two injections 12 weeks apart. Study participants will be evaluated through clinical observation and blood draws at specific times during the study and will be followed by clinical study staff for 52 weeks after their last vaccination.

For more information on clinical trials, visit ClinicalTrials.gov using the study identifier NCT05398796.

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