The phase I clinical trial of an experimental mRNA Nipah virus vaccine has begun at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The vaccine is a collaboration between the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) and Moderna, which used the mRNA technology to develop the Covid-19 vaccine.

Designed as a dose-escalation trial, it will examine the safety, tolerability and immunogenicity of the vaccine. Forty healthy adults, aged 18-60 years, will be enrolled for the trial and assigned to four groups. Each group will be administered two doses of the vaccine intramuscularly (in the shoulder muscle) in a gap of 4 weeks or 12 weeks. The vaccine dose varies across the four groups. The first group will receive two doses of 25 µg, the second group two doses of 50 µg, while for the third group, the vaccine dose is 100 µg. The results of preliminary analysis of data from these three groups will decide the dose for the fourth group to be given at an interval of 12 weeks. The follow-up period is for 52 weeks after the second vaccine dose. The participants will be examined at stipulated time points in the study.

Nipah virus infection is a zoonotic disease and spreads by direct contact with infected animals or through their saliva or blood or urine. It is a highly infectious virus. The natural hosts for the Nipah virus are fruit bats. Human to human transmission can also occur. Treatment is mainly supportive as there is no specific treatment. There is no vaccine available either. The case fatality is as high as 75%. Nipah outbreaks have been reported from Malaysia, India and Bangladesh. India has reported three outbreaks in 2001, 2007 and 2018. One case each was detected in 2019 and 2021. So far, the disease has been limited to Kerala and West Bengal.

Nipah virus infection has been recognized as one among the 10 priority diseases for the WHO Research and Development Blueprint because of its potential to cause an epidemic or even a pandemic. Hence, “The need for a preventive Nipah virus vaccine is significant,” said Dr Anthony S. Fauci, Director NIAID.

 Source: NIH News release, July 11, 2022