Indian Immunologicals Receives Regulatory Approval for Phase I Trial of Kyasanur Forest Disease Vaccine
核心洞察
The Subject Expert Committee on vaccine has recommended approval for Indian Immunologicals Ltd (搜索) to conduct a phase I clinical trial of an inactivated Kyasanur Forest Disease (搜索) vaccine.
The randomized, double-blind, placebo-controlled study will evaluate safety, reactogenicity, and immunogenicity in healthy Indian adults aged 18-49 years.
Kyasanur Forest Disease (搜索) is a tick-borne viral hemorrhagic fever (搜索) endemic to Western Ghats region, causing high fever and potentially neurological manifestations.
The Subject Expert Committee (SEC) on vaccine has recommended approval to Hyderabad-based Indian Immunologicals Ltd (搜索) (IIL (搜索)) to conduct a phase I clinical trial for an inactivated Kyasanur Forest Disease (搜索) (KFD) vaccine, marking a significant step forward in addressing this endemic viral hemorrhagic fever (搜索) also known as monkey fever (搜索).
Trial Design and Protocol
The approved phase I study is titled "A first-in-human randomized, double-blind, placebo-controlled Phase I study in healthy, Indian adults to evaluate the safety, reactogenicity, and immunogenicity of inactivated KFD vaccine (搜索) developed by the Human Biologicals Institute." The trial will enroll healthy volunteers aged 18-49 years in KFD endemic areas.
The study protocol calls for a two-dose regimen with each dose containing equal to or greater than 18 micrograms, administered 28 days apart. Safety and immunogenicity follow-up will continue for 366 days, with the company required to submit a Data and Safety Monitoring Board (DSMB) report after 57 days to the Central Drugs Standard Control Organisation (CDSCO) before planning phase II trials.
Vaccine Development and Preclinical Data
IIL (搜索) developed the inactivated adjuvanted KFD vaccine (搜索) based on a specific strain of live Kyasanur Forest Disease (搜索) virus isolated by the Indian Council of Medical Research's National Institute of Virology (ICMR-NIV), Pune. The development is being conducted in collaboration with ICMR.
Preclinical studies, including single dose and repeat dose toxicity assessments and immunogenicity evaluations, concluded that the vaccine was safe, well tolerated, and immunogenic. The company has also initiated developmental and reproductive toxicology (DART) studies, with female volunteers to be recruited only after completion of these studies.
Disease Background and Clinical Need
Kyasanur Forest Disease (搜索) is a tick-borne viral hemorrhagic fever (搜索) endemic to the Western Ghats region, primarily affecting Karnataka and neighboring states including Kerala, Tamil Nadu, and Goa. The disease is caused by a flavivirus (搜索) of the family flaviviridae, with vectors commonly consisting of haemaphysalis spinigera, dermacentor, and ixodes ticks.
According to the National Centre for Disease Control (NCDC), KFD is a re-emerging zoonotic disease characterized by sudden onset of high-grade fever, prostration, nausea, vomiting, diarrhea, and occasionally neurological and hemorrhagic manifestations. Humans contract the disease through infected tick bites or contact with infected animals, with no evidence of human-to-human transmission.
The disease was first discovered in 1957 in the Kyasanur forest area of Shimoga district, Karnataka, from which it derives its name. Currently, the available KFD vaccine (搜索) is a formalin-inactivated tissue culture vaccine manufactured at the Institute of Animal Health & Veterinary Biologicals, Hebbal, Bengaluru for the Department of Health & Family Welfare, Government of Karnataka.
Study Objectives and Endpoints
The primary objectives include evaluating safety, reactogenicity, and immunogenicity of the investigational vaccine. The study is expected to provide data on participants who achieve seropositivity as specified in the protocol. Additionally, IIL (搜索) plans to compare immunogenicity in subgroups identified at baseline based on flavivirus (搜索) serostatus, which could provide valuable insights into vaccine performance across different populations with varying prior exposure to related viruses.