The National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) has initiated a Phase I clinical trial of Moderna’s experimental vaccine, mRNA-1215, for preventing Nipah virus infection.
Moderna manufactured the vaccine, which was developed in partnership with Vaccine Research Center of NIAID.
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The vaccine is based on a messenger ribonucleic acid (mRNA) platform, a technology utilised in various Covid-19 vaccines that are currently approved.
Sponsored by NIAID, the trial is being carried out at the NIH Clinical Center in Bethesda, Maryland, US.
The dose-escalation trial will analyse mRNA-1215’s safety, tolerability and potential to induce an immune response in 40 healthy adult subjects aged 18 to 60 years.
It will have four groups enrolling 10 subjects each and they will be given two doses of the vaccine through injection in the shoulder muscle at a gap of four or 12 weeks.
Subjects in group one will be given two 25mcg vaccine doses while groups two and three will receive two 50mcg and 100mcg vaccine doses, respectively, four weeks apart.
As per the interim assessment data from these groups, the vaccine dose for the fourth group of subjects will be determined.
The NIH noted that the fourth group will be given two vaccine doses at a gap of 12 weeks.
Clinical observation and blood collection will be carried out in trial subjects at specified times throughout the trial and monitored till 52 weeks following administration of last vaccine dose.
NIAID director Anthony Fauci said: “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.”
“The need for a preventive Nipah virus vaccine is significant.”
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