Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in a Phase 1 trial of its Nipah virus (NiV) vaccine candidate, mRNA-1215, that was developed in collaboration with the Vaccine Research Center (VRC), a division of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). 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 NiV 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. 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,” said Stéphane Bancel, Chief Executive Officer of Moderna.
The 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. The ClinicalTrials.gov identifier is NCT05398796.
NiV 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. NiV is a deadly pathogen that can cause rapidly progressive illness, including acute respiratory infection and encephalitis that can lead to a coma or death. While it is possible to recover, an estimated 40% to 75% of people infected with NiV die as a result of infection.
Since the first identification of NiV 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 NiV 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).
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