Nipah monoclonal antibody trials may begin in India in 2025

Nipah monoclonal antibody trials may begin in India in 2025

Subject: Science and tech

Sec: Health

Context:

The Indian drug regulator greenlights it, a human clinical trial to test the safety and efficacy of a novel Nipah monoclonal antibody MBP1F5, which might offer immediate protection to people at risk of infection against the deadly disease, might begin next year.

More About News:

• A trial will be carried out in Bangladesh as well. Though trials on many vaccines are currently under way, there is no approved vaccine against the Nipah virus anywhere in the world.
• Nipah virus has a 40% to 75% mortality rate in people who are

Outbreaks:

• India and Bangladesh have been chosen for the trial as Nipah virus outbreaks have been reported in these two countries in recent years.
• Nipah outbreaks have occurred in Kerala in 2018, 2019, 2021 and 2023. In the case of Bangladesh, Nipah outbreaks have been occurring since 2001; the virus has been reported from 34 of 64 districts in Bangladesh with 341 cases detected so far and 242 deaths.
• The novel Nipah monoclonal antibody is currently undergoing a phase-1 clinical trial in the U.S., which is carried out by the S. Department of Defence.
• The trial in India and Bangladesh will begin “upon completion of the U.S. Department of Defence Phase-1 trial in the U.S”. The trial in India is planned to begin in 2025, pending regulatory review.
• The number of participants who will be recruited for the clinical trial will depend on whether the clinical trial begins as a phase-1 or phase-2 trial in India. But the intention is to recruit at least 200 participants.

Study of Nipah Virus:

• Preclinical studies for pre-exposure prophylaxis have been completed in animal models, the monoclonal antibody has demonstrated high potency against the Nipah virus, providing it effective at preventing the virus from entering the host cell.
• The monoclonal antibody is designed to bind to the Nipah virus F protein, preventing the virus from entering a host cell and causing infection in people.
• This mechanism will offer protection against both known strains of Nipah virus (Bangladesh and Malaysia) and its closely related viral cousin, Hendra virus, for at least six months enough time for vaccine immunity to build.

Availability:

• Ensuring pricing commitments for Global South countries, a reserve of monoclonal antibody doses will be stored in a Nipah-affected country, helping to enable rapid availability in the event of an outbreak and accessibility for those most in need.