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 |
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.
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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