A Phase 1 Study Of INO-A002 In Healthy Dengue Virus-Naive Adult
Brief description of study
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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Healthy Volunteer
-
Age: Between 18 Years - 60 Years
-
Gender: All
Requirements to Enter
Study:
·
18 to 60 years old
·
Women of child-bearing age potential must agree
to use medically effective contraception (oral, barrier methods, spermicide,
etc.) or have a partner who is sterile from enrollment to 6 months following
the last injection
·
Sexually active men who are fertile must agree
to use a barrier method of contraception for at least 6 months following the
last injection
·
No history of dengue virus vaccination or illness
·
No plans to travel to
Caribbean, Central or South America during the 6 months following the last
injection
·
Must be willing to
allow storage and future use of samples for Zika virus related research
·
Will remain in the
Philadelphia area for 1 year following the last injection for study visits
Updated on
10 Jul 2023.
Study ID: 832135