Conduct Phase II CT : CDSCO panel opines Zydus Pharma over Hepatitis E Vaccine
New Delhi: The Subject Expert Committee(SEC) functional under the Central Drug Standard Control Organization(CDSCO) has opined the pharma major Zydus Pharma that the firm should conduct Phase II clinical trail of Recombinant Hepatitis E Vaccine (Adsorbed) with adequate sample size before proposing for Phase-III clinical trial.This came after the pharma major Zydus Pharma presented its...
New Delhi: The Subject Expert Committee(SEC) functional under the Central Drug Standard Control Organization(CDSCO) has opined the pharma major Zydus Pharma that the firm should conduct Phase II clinical trail of Recombinant Hepatitis E Vaccine (Adsorbed) with adequate sample size before proposing for Phase-III clinical trial.
Hepatitis E is inflammation of the liver caused by the hepatitis E virus (HEV). The virus has at least 4 different types: genotypes 1, 2, 3 and 4. Genotypes 1 and 2 have been found only in humans. Genotypes 3 and 4 circulate in several animals including pigs, wild boars and deer without causing any disease, and occasionally infect humans.
The virus is shed in the stools of infected persons and enters the human body through the intestine. It is transmitted mainly through contaminated drinking water. The infection is usually self-limiting and resolves within 2–6 weeks. Occasionally a serious disease known as fulminant hepatitis (acute liver failure) develops, which can be fatal.
At the recent SEC meeting for vaccines held on 6th September 2022,the expert panel reviewed proposal presented by the Zydus Pharma to conduct Phase II/III clinical trail of Recombinant Hepatitis E Vaccine (Adsorbed) in age group of 16-65.
A recombinant hepatitis E vaccine, HEV 239, is already licensed in China for immunizing adults of 16 y old and above. The vaccine antigen contains pORF2 aa 368 - 606 of the HEV genotype 1 expressed in E. coli. Studies reported that the efficacy of the HEV 239 vaccine against symptomatic and asymptomatic infection had been proven to be high during a Phase III clinical trial and long-term follow up. The safety and efficacy of HEV 239 vaccine in certain high-risk populations remains to be further investigated.
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