Trial | NCT03805984  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    INO-4500 ...

  • Study Participants

    60
This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.
Study Started
May 09
2019
Primary Completion
Oct 21
2020
Study Completion
Oct 21
2020
Last Update
Nov 23
2020

Drug INO-4500

INO-4500 will be administered ID on Day 0 and Week 4.

Drug Placebo

Placebo will be administered ID on Day 0 and Week 4.

  • Other names: SSC-0001

Device CELLECTRA® 2000

EP using the CELLECTRA® 2000 device will be administered following ID drug administration.

INO-4500 Group A Experimental

Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device

Placebo Comparator Group A Placebo Comparator

Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device

INO-4500 Group B Experimental

Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device

Placebo Comparator Group B Placebo Comparator

Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device

Criteria 

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 (e.g. Wolff-Parkinson-White syndrome);
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 1 month following last dose;
Is currently participating in or has participated in a study with an investigational product within 30 days preceding 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;
Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz;
Recent (within 6 months) or planned travel to Lassa-endemic region;
Current or anticipated concomitant immunosuppressive therapy.
No Results Posted