The Indian Council of Medical Research has moved an indigenous vaccine candidate for Kyasanur Forest Disease, commonly known as monkey fever, into Phase I human trials in collaboration with Hyderabad based Indian Immunologicals. The development marks a crucial step toward strengthening India’s response to a regionally endemic tick-borne viral infection that has long troubled communities in the Western Ghats.
Indigenous vaccine enters first in human testing
The investigational vaccine is a two dose adjuvanted inactivated candidate that has been developed following a request from the Karnataka government. Preclinical work has already been completed, including toxicity studies, and GLP-grade vaccine material has been manufactured to enable the transition into clinical evaluation.
According to ICMR, if the Phase I study demonstrates that the vaccine is safe and capable of triggering an immune response, the program will progress to further clinical trials before seeking regulatory approval from the Central Drugs Standard Control Organisation.
Burden of Kyasanur Forest Disease in India
Kyasanur Forest Disease is a vector-borne zoonotic infection transmitted to humans through the bite of infected ticks that typically feed on monkeys, which act as amplifying hosts. In India, KFD has been reported as a regional infectious disease along the Western Ghats, particularly in Karnataka, Tamil Nadu, Kerala, Goa, and Maharashtra, where recurrent outbreaks have raised public health concerns.
The disease is associated with acute febrile illness and can lead to significant morbidity, highlighting the need for safe and effective preventive tools tailored to endemic settings.
What Phase I trials aim to establish
The ongoing Phase I trial represents the first time this KFD vaccine candidate is being tested in humans, focusing on a small group of healthy adult volunteers. The primary objectives at this stage are to assess safety, monitor side effects, and determine an appropriate dosage range before moving to larger studies that evaluate efficacy in at risk populations.
ICMR has indicated that only after confirming safety and immunogenicity in early phase studies will the developers approach CDSCO for marketing authorisation, in line with national regulatory standards for new vaccines.
