A phase 1 randomized clinical trial of a novel Nipah virus vaccine led by researchers from Cincinnati Children’s Hospital Medical Center in the US has shown promising results that could pave the way for preventing the deadly infection.
The vaccine, HeV-sG-V, was tested in three doses and regimens and was found to be safe while generating an immune response in all participants. The trial included 192 healthy adults aged 18 to 49 years.
Nipah virus disease is a zoonotic infection that can cause acute encephalitis, severe respiratory illness, and in many cases, death, highlighting the urgent need for effective preventive measures.
The study, published in The Lancet, showed that while a single dose was insufficient, two doses spaced 28 days apart produced the highest immune response, with neutralizing antibody levels rising sharply seven days after the second dose. Mild-to-moderate injection site pain was the most commonly reported side effect, and no serious adverse events, hospitalizations, or deaths occurred.
First identified in Malaysia in 1999, the Nipah virus causes recurrent outbreaks across South and Southeast Asia, including India, with mortality rates ranging from 40 to 75 percent. The World Health Organization classifies the virus as a high-priority pathogen due to its high fatality rate of up to 82 percent and the absence of approved treatments or vaccines.
The US researchers noted that the induction of antibodies within one month of vaccination and the persistence afforded by two doses suggest the vaccine has potential for both reactive outbreak control and preventive use.
Experts from the Indian Council of Medical Research–National Institute of Virology in Uttar Pradesh considered the findings a milestone in the development of Nipah vaccines and recommended further testing in larger phase 2 trials to assess safety and determine the level of protection the vaccine may offer.
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