Therapeutic Hepatitis C Virus Vaccine

Chronic Hepatitis C Infection Clinical Trial

Official title: A Phase I Trial of an Immunotherapy (HCVax™) in Chronic Hepatitis C Infected Patients

Status Recruiting

Clinical Trial Summary

GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients.

Clinical Trial Description

GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients. Chronic HCV patients will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed up for safety and immunological response through week 28. All vaccine recipients will take part in a long-term safety follow-up for 6 months following the completion of the vaccine series to assess delayed adverse events.

Vaccination will first start at low dose. The investigators will enroll low dose group first. Two subjects will be staggering enrolled every 2 weeks. Following the assessment and review of prior vaccinations, if no vaccine definitely or probably-related severe adverse event (grade 3 or above) or SAE occurs the vaccination schedule for low dose and high dose will continue until complete enrollment.

Each subject will receive HCVax™ vaccine at 0, 8, 16 weeks through subcutaneous route. Following vaccination subjects will have clinical, immunological and virologic assessments throughout the 28-week study. ;

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

• NCT number: NCT04318379
• Study type: Interventional
• Source: GeneCure Biotechnologies
• Contact: Frank Tung, Ph.D
• Phone: 7702637508
• Email: frank@genecure.com
• Status: Recruiting
• Phase: Phase 1
• Start date: April 20, 2021
• Completion date: December 2023