Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers



Status:Not yet recruiting
Healthy:No
Age Range:18 - 50
Updated:3/7/2019
Start Date:April 15, 2019
End Date:August 2020
Contact:Inovio Call Center
Email:clinical.trials@inovio.com
Phone:(267) 440-4237

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Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

This is a dose finding trial to evaluate the safety, tolerability and immunological profile
of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using
the CELLECTRA® 2000 device in healthy adult volunteers.


Inclusion Criteria:

- Judged to be healthy by the Investigator on the basis of medical history, physical
examination and vital signs performed at Screening;

- Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human
Immunodeficiency Virus (HIV) antibody;

- Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically
significant findings;

- Use of medically effective contraception with a failure rate of < 1% per year when
used consistently and correctly from screening until 6 months following last dose or
be post-menopausal or be surgically sterile or have a partner who is sterile.

Exclusion Criteria:

- Pregnant or breastfeeding, or intending to become pregnant or father children within
the projected duration of the trial starting with the screening visit until 6 months
following last dose;

- Administration of an investigational product within 30 days of Day 0;

- Previous receipt of an investigational vaccine product for prevention of Lassa Fever;

- Fewer than two acceptable sites available for ID injection and EP considering the
deltoid and anterolateral quadriceps muscles;

- Current or anticipated concomitant immunosuppressive therapy.
We found this trial at
1
site
Kansas City, Missouri 64114
Principal Investigator: John E Ervin, MD
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mi
from
Kansas City, MO
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