NCT04318379

Therapeutic Hepatitis C Virus Vaccine

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: GeneCure Biotechnologies · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
BIOLOGICAL	HCVax	HCVax is a lentiviral vector encoding several HCV antigens

Timeline

• Start date: 2021-04-20
• Primary completion: 2023-02-01
• Completion: 2023-12-01
• First posted: 2020-03-24
• Last updated: 2021-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study