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

Inovio Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Lassa Fever

Treatments: Device: CELLECTRA® 2000; Drug: Placebo; Drug: INO-4500

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03805984

LSV-001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy 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 (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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

60 participants in 4 patient groups, including a placebo group

INO-4500 Group A

Experimental group

Description:

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

Treatment:

Drug: INO-4500

Device: CELLECTRA® 2000

Placebo Comparator Group A

Placebo Comparator group

Description:

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

Treatment:

Device: CELLECTRA® 2000

Drug: Placebo

INO-4500 Group B

Experimental group

Description:

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

Treatment:

Drug: INO-4500

Device: CELLECTRA® 2000

Placebo Comparator Group B

Placebo Comparator group

Description:

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

Treatment:

Device: CELLECTRA® 2000

Drug: Placebo