CEPI Announces Plans for Nipah Virus Antibody Trials

The Coalition for Epidemic Preparedness Innovations (CEPI) has unveiled plans to initiate clinical trials for MBP1F5, a monoclonal antibody (mAb) designed to combat the Nipah virus, in India and Bangladesh. This initiative is particularly significant given the historical context of Nipah virus outbreaks in these regions.

Historical Context

The Nipah virus, first identified in Malaysia in 1998, has since caused multiple outbreaks, particularly in South and Southeast Asia. The virus is known for its high mortality rate and its ability to cause severe respiratory and neurological symptoms. Annual outbreaks in India and Bangladesh have underscored the urgent need for effective preventive measures.

Details of the Trials

• Funding and Leadership: CEPI has allocated $43.5 million for these trials, which will be spearheaded by biotechnology company ServareGMP, with support from Mapp Biopharmaceutical.
• Objective: The primary aim is to evaluate the safety and tolerability of MBP1F5 in healthy adults across various trial sites in India and Bangladesh.
• Mechanism: MBP1F5 works by binding to the F protein of the Nipah virus, potentially blocking the virus from infecting host cells. This strategy could offer protection against both known strains of the Nipah virus (Bangladesh and Malaysia) and the related Hendra virus.
• Duration of Protection: The goal is to provide protection for at least six months, allowing sufficient time for vaccine-induced immunity to develop.

Additional Research

The investment will also support preclinical studies to explore the mAb’s potential for both pre-exposure and post-exposure prophylaxis. Currently, the Nipah mAb is in Phase I safety testing by the US Department of Defense (US DoD) under a contract with Mapp Biopharmaceutical.

Future Steps

Upon the completion of the Phase I trial by the US DoD, CEPI will back the subsequent clinical safety assessments led by ServareGMP and Mapp.

Importance of the Initiative

CEPI CEO Richard Hatchett emphasized the critical need for immediate protection for healthcare workers and family members caring for infected individuals. A monoclonal antibody capable of offering such protection would be a significant addition to the arsenal against the Nipah virus.

Summary

• Initiative: CEPI to start clinical trials for Nipah virus antibody MBP1F5 in India and Bangladesh.
• Funding: $43.5 million allocated by CEPI.
• Leadership: Trials led by ServareGMP with support from Mapp Biopharmaceutical.
• Objective: Evaluate safety and tolerability in healthy adults.
• Mechanism: MBP1F5 targets the F protein of the Nipah virus.
• Protection Duration: Aims to offer at least six months of protection.
• Current Status: Phase I safety testing by the US DoD.
• Future Steps: CEPI to support further clinical safety assessments.
• Significance: Provides immediate protection for those at risk, including healthcare workers and caregivers.