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Monday, September 26th, 2022

NIAID launches clinical phase 1 trial of mRNA Nipah virus vaccine

© NIAID

Nipah virus became the newest target of the National Institute of Allergy and Infectious Diseases (NIAID) this week, with the launch of a phase 1 clinical trial to evaluate an investigational vaccine from Moderna, Inc. and NIAID’s own Vaccine Research Center.

This potential vaccine was built from a messenger RNA (mRNA) platform, and its trial will be conducted at the National Institutes of Health Clinical Center in Bethesda, Maryland. It will be tested via a dose-escalation clinical trial to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults between 18 and 60 years old. This group will be divided into four groups of 10 participants, and each participant will be injected with two doses of the vaccine in the shoulder four or 12 weeks apart. These doses will vary between 25 mcg and 100 mcg injections, depending on the group.

“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,” Dr. Anthony Fauci, director of NIAID, said. “The need for a preventive Nipah virus vaccine is significant.”

Nipah is a disease spread between animals and people, most commonly from fruit bats. While most common in Asia, particularly in Bangladesh and India, it crops up annually. Its effects can be mild or severe, with death rates of up to 75 percent and effects that include respiratory infection, brain swelling, and comas. No vaccine currently exists for Nipah, and NIAID considers it a disease with pandemic potential.

In this case, study participants will be observed and blood samples collected up to 52 weeks after the final vaccination.