Hepatitis C Infection Clinical Trial
Official title:
Phase I Trial of a Therapeutic DNA Vaccine for Chronic Hepatitis C Virus (HCV) Infection
This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA) vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or progresses over a long period of time. Vaccines made from DNA may help the body build an effective immune response to kill cancer cells that express HCV infection.
PRIMARY OBJECTIVES:
I. To determine the safety profile of the HCV DNA vaccine, consisting of INO-8000 (HCV
antigen DNA) alone or co-administered with INO-9012 (interleukin [IL]-12 adjuvant DNA) (DNA
plasmid encoding interleukin-12 INO-9012) II. To identify a dose of INO-9012 (IL-12 adjuvant
DNA) for co-administration with INO-8000 (HCV antigen DNA) based on induction of
HCV-specific interferon (IFN)-gamma production by peripheral blood mononuclear cells at 26
weeks compared to baseline in HCV-infected participants.
SECONDARY OBJECTIVES:
I. Determine the rate at which INO-8000 with different doses of INO-9012 induces a > 1 log
decrease (or undetectable) in HCV RNA level at weeks 14 and 26.
II. Determine the rate at which INO-8000 with different doses of INO-9012 induces an
end-of-treatment undetectable HCV ribonucleic acid (RNA) (end-of-treatment virologic
response - EVR) at 26 weeks and a sustained virologic response (SVR) at 36 weeks.
III. Determine the rate at which INO-8000 with different doses of INO-9012 induces other
parameters of cluster of differentiation (CD)8 and CD4 T lymphocyte responses as measured by
flow cytometry, and antibody responses to HCV antigen at weeks 14 and 26.
OUTLINE: This is a dose-escalation study of INO-9012.
Patients receive INO-8000 intramuscularly (IM) and DNA plasmid encoding interleukin-12
INO-9012 IM (dose levels 2-4) followed by electroporation (EP) at day 0 and at weeks 4, 12,
and 24.
After completion of study treatment, patients are followed up at weeks 48 and 76.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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