India begins human trials of new indigenous forest fever vaccine India News

New Delhi: India has taken another step towards strengthening its defense against Kisanur Forest Disease (KFD), a tick-borne viral infection that has long plagued forest fringe communities in the Western Ghats. The Indian Council of Medical Research (ICMR) has initiated Phase 1 human clinical trials of the newly developed fully indigenous vaccine after completing pivotal laboratory and animal studies.The vaccine program was launched at the behest of the government of Karnataka, one of the states worst affected by recurring KFD outbreaks. The disease is endemic in parts of Karnataka, Tamil Nadu, Kerala, Goa and Maharashtra and is associated with high fever, severe weakness and, in some cases, fatal complications.The vaccine candidate was developed by the Department of Health Research, Ministry of Health and Family Welfare, as a joint effort between Indian Immunology Ltd. and ICMR-National Institute of Virology. It is a two-dose, adjuvanted, inactivated vaccine administered 28 days apart.Officials said animal challenge and toxicity studies have been successfully completed and GLP-grade vaccine materials have been produced. Phase 1 human trials have now begun to assess safety and early immune responses, approved by the national drug regulatory agency, the Central Drug Standards Agency.If Phase 1 trials show the vaccine is safe and immunogenic, it will move into larger clinical trials before seeking full regulatory approval. Scientists say the new vaccine candidate aims to overcome limitations of the existing KFD vaccine, which requires repeated booster doses and has shown varying effectiveness in the field.The government says it will continue to support state governments in tackling critical public health challenges, with the KFD vaccine effort seen as part of a wider push to leverage indigenous research and manufacturing capabilities to develop solutions to region-specific infectious diseases.