Conduct Phase II CT : CDSCO panel opines Zydus Pharma over Hepatitis E Vaccine

Written by Dr. Divya Colin Published On 2022-09-14T18:00:30+05:30 | Updated On 14 Sept 2022 6:00 PM IST

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 proposal for grant of permission to conduct Phase II/III clinical trial of Recombinant Hepatitis E Vaccine (Adsorbed) in subjects aged 16 to 65 years along with the Phase I clinical trial report.

In addition, the firm also presented pre-clinical studies in mice, rats & rabbits.

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.

The committee noted that the Phase II/III trial is proposed with three dose schedule (30mcg/0.5ml/dose) at 0, 1 and 6 months by intramuscular route. (IM)

Furthermore, the committee also noted that the similar Hepatitis E vaccine is approved and marketed only in China.

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.

After detailed deliberation, the committee recommended that the firm should initially conduct Phase II clinical trial with adequate sample size before proposing for Phase-III clinical trial.

In accordance with the above, the committee further directed the firm to submit Phase-II clinical trial protocol before the committee for review.

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Recombinant Hepatitis E Vaccinezydusclinical-trialphase-2 trialHepatitis Ecdsco panel

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.