A Phase I Single-blind Randomised Placebo Controlled Dose Escalating Study of One Virosome Formulated CD4 and Two Virosomes Formulated CD8 Hepatitis C Virus (HCV) Vaccine Components (PEV2A and PEV2B) Administered to Healthy Adult Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Incidence of adverse events
Study Overview
Brief Summary
Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers of both sexes
- •Aged between 18 and 45 years
- •Free of obvious health problems
- •With a BMI between 18.5 and 29.9 are included if they give written informed consent
Exclusion Criteria
- •Chronic or acute illness
- •Immunosuppression
- •HCV and/or HBV infection
- •history of allergic disease
- •Pre-existing immune response against peptide of the vaccines
Outcomes
Primary Outcomes
Incidence of adverse events
Specific cellular immune response by Elispot and FACS
Secondary Outcomes
- Specific proliferative response
- Humoral immunity