If 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. A similar 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. The Nipah virus has a 40% to 75% mortality rate in people who are infected.
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 U.S. Department of Defence.
Aspokesperson of the Coalition for Epidemic Preparedness Innovations (CEPI), which is funding the human trials, told The Hindu that the trial led by ServareGMP (a non-profit biotechnology organisation based in California) and supported by Mapp Biopharmaceutical, which is also located in California, will work with local clinical research networks to carry out the trial in India and Bangladesh.
The trial in India and Bangladesh will begin “upon completion of the U.S. Department of Defence Phase-1 trial in the U.S”. “ServareGMP, Mapp and CEPI have already initiated discussions with public health and regulatory authorities in India and Bangladesh about the desire to conduct this trial,” he says.
According to the CEPI spokesperson, the trial in India is planned to begin in 2025, pending regulatory review. The assessment made by the Indian drug regulator will determine “whether the Phase-1 trial data carried out by the U.S. Department of Defence will be sufficient to continue onwards with Phase-2 trials in India, or whether Phase-1 data should also be collected from the Indian population”.
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,” says the spokesperson.
While the trial will be conducted in multiple sites in both countries, the decision on the location and number of sites appropriate to generate data that demonstrate the safety and tolerability of the monoclonal antibody will be taken based upon consultation with public health and regulatory authorities, he says.
“Preclinical studies for pre-exposure prophylaxis have been completed. In these studies, conducted in animal models, the monoclonal antibody has demonstrated high potency against the Nipah virus, proving it effective at preventing the virus from entering the host cell and causing Nipah virus disease. In preclinical studies, this Nipah monoclonal antibody has been shown to be safe at all dose levels tested,” he says.
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,” says a CEPI release.
In response to a question about equitable access to monoclonal antibodies, once the trial results are positive, he says: “CEPI, ServareGMP and Mapp are committed to enabling equitable access to the outputs of their partnership in line with CEPI’s Equitable Access Policy. Alongside 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.”
Published - July 13, 2024 09:10 pm IST
