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Hepatitis C Virus Infection - Healing Genes
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Hepatitis C Virus Infection

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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


Phase 1

DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  1. Screening to confirm acceptance to the study.
  2. Intramuscular injection of the therapy or placebo, with CELLECTRA™-5PSP electric muscle stimulation to enhance absorption of the vaccine
  3. Repeat of step (2) at 4 weeks, 12 weeks, and 24 weeks
  4. 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]

SPONSORS

National Cancer Institute (NCI)

Inovio Pharmaceuticals

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02772003

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