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The Subject Expert Committee (SEC) on vaccine has recommended approval to Hyderabad-based Indian Immunologicals Ltd (IIL) to conduct a phase I clinical trial for inactivated Kyasanur Forest Disease (KFD) vaccine to treat the KFD, also known as monkey fever, as per the protocol submitted by the company.
The Committee was considering a phase I clinical trial protocol 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 developed by the Human Biologicals Institute".
KFD is a tick borne viral haemorrhagic fever that is endemic to Western Ghats region of primarily Karnataka and other neighboring states like Kerala, Tamil Nadu and Goa. It is caused by a virus - flavivirus of family flaviviridae - and vectors of these viruses commonly consist of haemaphysalis spinigera, dermacentor and ixodes ticks.
The Committee noted that IIL has developed an inactivated adjuvanted KFD vaccine based on a certain strain of live Kyasanur Forest Disease virus isolated by Indian Council of Medical Research's National Institute of Virology (ICMR–NIV), Pune and proposed for first-in human phase I study in collaboration with ICMR.
It has also conducted pre-clinical toxicity - single dose and repeat dose - and immunogenecity studies with inactivated KFD vaccine, and these studies, the vaccine was concluded to be safe, well tolerated and immunogenic.
Following this, the company proposed to conduct first-in-human study as two dose, equal to or greater than 18 microgram in each dose, 28 days apart in healthy volunteers of 18-49 years of age in a KFD endemic area.
The outcome is also expected to provide data relating to the participants who achieve seropositivity as specified in the protocol. The company also proposed to compare immunogenecity in subgroups identified at baseline based on flavivirus serostatus, added the SEC while considering the proposal.
The study will be continued till 366 days for safety and immunogenicity follow-up. The company is expected to submit the Data and Safety Monitoring Board (DSMB) report after 57 days to the CDSCO before planning for conduct of phase II clinical trial.
IIL has also initiated developmental and reproductive toxicology (DART) study and as per clinical trial protocol, female volunteers will be recruited after completion of DART study, it added.
According to the CD Alert newsletter of the National Centre for Disease Control (NCDC), under the Directorate General of Health Services, KFD is a re-emerging zoonotic disease associated with sudden onset of high grade fever, prostration, nausea, vomiting, diarrhea and occasionally neurological and haemorrhagic manifestations.
Humans can get the disease form an infected tick bite or by contact with an infected animal, and data does not suggest any human-to-human transmission. This disease was first discovered in 1957 from Kyasanur forest area, Shimoga district of Karnataka state in southern India. It derives its name from the forest range where the virus was first isolated.
The alert stated that the currently available KFD vaccine is formalin inactivated tissue culture vaccine, manufactured at the Institute of Animal Health & Veterinary Biologicals, Hebbal, Bengaluru for Department of Health & Family Welfare, Government of Karnataka.
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