A Phase 1 Study Of INO-A002 In Healthy Dengue Virus-Naive Adult

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Study Overview

The main purpose of this study is to evaluate the tolerability and safety of escalating injection doses of ‘INO-A002” with Hylenex. Through these injections, we hope to see the resulting expression of the monoclonal antibody ZK190. Monoclonal antibodies are laboratory-produced molecules which serve as substitute antibodies and can enhance or mimic the immune system's attack on Zika. The monoclonal antibody ZK190 will target the envelope protein of Zika virus in order to prevent the virus in healthy adults.
 
Electroporation (EP) by the CELLECTRA 2000 device will be used to increase cellular uptake of “INO-A002”. EP has been shown to be an effective way to introduce DNA into cells and to increase the expression levels of antigens encoded by DNA. 

Study Description

Treatment:
 
Before injection, temperature, blood pressure, heart rate (pulse) and weight will be collected, and a targeted physical examination will be performed. “INO-A002” will be injected intramuscularly followed by EP with the CELLECTRA 2000 device. Prior to injection, blood samples will be collected for CPK and urine samples will be collected for urinalysis and urine pregnancy test.
 
For this study, some possible side-effects include: mild to moderate administration site pain or swelling, fatigue or myalgia in the first few days following injection, and visible lesion or bruising at injection site.  
Your study nurse will inform you about the schedule of visits for the following months. 

Additional Information:

Duration of Study:
 
52 weeks
 
For more information contact:
 
Eileen Donaghy, MSN, CRNP
Study Coordinator
ACTU site 6201
Eileen.donaghy2@uphs.upenn.edu
215-349-8011 fax
215-349-8092 office ph

  • Study Identifier: 832135

Recruitment Status

Open

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