U.S. researchers have launched the first clinical trial of an mRNA vaccine targeting Nipah virus, a deadly pathogen that kills up to 70% of those infected and has been identified as a significant pandemic threat.
The experimental vaccine, designated mRNA-1215 and developed by Moderna, is being tested by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) under National Institutes of Health (NIH) sponsorship.
"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," said NIAID Director Anthony Fauci. "The need for a preventive Nipah virus vaccine is significant."
The Deadly Nipah Threat
First documented during a 1998 outbreak in Malaysia and Singapore, Nipah virus infected 265 people and claimed 105 lives. The outbreak also devastated the regional pig farming industry, causing nearly $1 billion in losses due to necessary culling measures.
Since then, outbreaks have occurred almost annually, primarily in India and Bangladesh. The virus typically spreads through contact with infected fruit bats, though human-to-human transmission has been documented, raising concerns about the potential emergence of highly transmissible strains.
Infected individuals experience a spectrum of symptoms ranging from mild illness to severe encephalitis, coma, and death. The World Health Organization has identified Nipah virus in bat populations across multiple countries, including Cambodia, Ghana, Indonesia, Madagascar, the Philippines, and Thailand.
Currently, no approved vaccines or treatments exist for Nipah virus infection, leaving vulnerable populations without protection against this lethal pathogen.
Trial Design and Vaccine Technology
The Phase 1 clinical trial will enroll 40 healthy adult volunteers who will receive escalating doses of the investigational vaccine to evaluate its safety, tolerability, and immunogenicity.
Participants will be divided into four groups of 10 individuals each, receiving two doses of mRNA-1215 at concentrations of 25 mcg, 50 mcg, or 100 mcg. The doses will be administered via intramuscular injection in the shoulder, spaced either four or 12 weeks apart. Researchers will monitor participants for a full year after completion of the two-dose regimen.
The vaccine utilizes the same mRNA platform technology that proved highly successful in Moderna's COVID-19 vaccine. This approach instructs cells to produce proteins that mimic those found on the virus, triggering an immune response without causing infection.
Part of a Broader Global Health Initiative
The Nipah virus vaccine represents one component of Moderna's global public health strategy, an ambitious initiative targeting 15 infectious diseases identified as posing the greatest worldwide public health risks.
The mRNA platform's versatility has enabled Moderna to rapidly develop vaccine candidates for multiple pathogens. Beyond COVID-19 and Nipah virus, the company is advancing mRNA vaccines against influenza, respiratory syncytial virus (RSV), HIV, malaria, and tuberculosis.
This trial marks an important step toward addressing a significant gap in global infectious disease preparedness. If successful, the vaccine could provide a crucial tool for preventing future Nipah outbreaks and potentially averting a devastating pandemic.
Public health experts emphasize that developing countermeasures against high-consequence pathogens like Nipah virus is essential for global health security, particularly as human encroachment into wildlife habitats increases the risk of zoonotic disease spillover events.
