This Phase 1 dose-escalation, open-label clinical trial is the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability, and immunogenicity of a Nipah mRNA vaccine.
"Our partnership with NIAID to advance mRNA-1215 for Nipah virus reflects our commitment to advance a portfolio of 15 vaccine programs by 2025, targeting emerging or neglected infectious diseases that threaten global health,” said Moderna's CEO, Stéphane Bancel.
“Since Nipah virus is a deadly pathogen for which there is currently no vaccine or treatment, Moderna is eager to bring our mRNA expertise to this partnership with the hope of halting the virus' pandemic potential to protect the health of our global citizens.”
Pandemic potential
Nipah is a zoonotic virus, meaning that it can spread between animals and people. The virus can be transmitted to humans from infected animals, through consumption of contaminated food, or directly from other infected persons. It is a deadly pathogen that can cause rapidly progressive illness, including acute respiratory infection and encephalitis that can lead to a coma or death (an estimated 40% to 75% of people infected die as a result of infection).
Since the first identification of Nipah virus in Malaysia in 1999, it has regularly spilled over from animals to humans, with outbreaks recorded almost annually in some parts of Asia. Although the dynamics of Nipah are unpredictable, the virus has a high rate of mutation and is considered a significant pandemic threat and a pathogen with bioterrorism potential. Because of its high pandemic potential, NiV is listed as a high-priority pathogen by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and the Coalition of Epidemic Preparedness Innovations (CEPI).
The Nipah vaccine was developed with the Vaccine Research Center (VRC), a division of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH.
The Phase 1 trial is sponsored and funded by NIAID. The IND sponsor is NIAID's Division of Microbiology and Infectious Disease (DMID) and the trial will be conducted by the NIAID's Vaccine Research Center.
In addition to the Nipah program, Moderna has advanced its Zika vaccine candidate (mRNA-1893) to Phase 2 clinical trials. Like Nipah, Zika is an emerging disease and is considered to be a looming threat to global health.
With the Nipah vaccine development program and the company's portfolio of COVID-19, Zika, and HIV clinical trials, Moderna has advanced four of the 15 priority vaccine programs it committed to developing by 2025, targeting emerging or neglected infectious diseases that threaten global health.
