DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection
Phase I Trial of a Therapeutic DNA Vaccine for Chronic Hepatitis C Virus (HCV) Infection
Doctors at several research center seek patients with Hepatitis C infection to trial therapeutic DNA vaccines. The vaccines are a loop of selected DNA from the hepatitis C virus. The body’s cells use the genes to produce proteins that prompt the body to attack Hep C virus. Additional genes code for production of the cell messengers (interleukins) that promote the immune system to fight HCV.
Study participants will receive intramuscular injections 4 times over 24 weeks, along with a therapy that causes the muscle cells to better absorb the vaccine. Follow up lasts ~36 weeks.
- Be 18 years of age or older
- Not be pregnant or breastfeeding
- Be willing to use adequate contraception to avoid pregnancy or impregnation for the duration of study participation
- Meet additional criteria specific to the progress of their HCV infection
THE STUDY INVOLVES:
- Screening to confirm acceptance to the study.
- Intramuscular injection of the therapy or placebo, with CELLECTRA™-5PSP electric muscle stimulation to enhance absorption of the vaccine
- Repeat of step (2) at 4 weeks, 12 weeks, and 24 weeks
- Follow up with lab and physical assessments for up to 36weeks.
LOCATIONS & CONTACTS:
The following study locations are participating:
Mayo Clinic in Florida in Jacksonville, FL. Map.
Contact: Surakit Pungpapong | 904-956-3200 | [email protected]
Mayo Clinic in Rochester, MN. Map.
Contact: Lewis R. Roberts | 507-284-2511 | [email protected]
Temple University Hospital in Philadelphia, PA. Map
Contact: James Robinson | 267-507-6609 | [email protected] .
University of Puerto Rico in San Juan, PR. Map.
Contact: Lemuel Melecio-Rodriguez | 787-772-8300 ext 1401 | [email protected]
National Cancer Institute (NCI)
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