Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana

Inovio Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Lassa Fever

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04093076

LSV-002

Details and patient eligibility

About

This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.

Enrollment: 220 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);
• Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months following last dose.

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 three (3) months following last dose;
• Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing;
• 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;
• Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 Hz - 8000 Hz;
• Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
• Current or anticipated concomitant immunosuppressive therapy;
• Fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 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

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 in two acceptable locations in two different limbs at each dosing visit.

Treatment:

Drug: INO-4500

Device: CELLECTRA™ 2000

Placebo Group C

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Device: CELLECTRA™ 2000

Placebo Group D

Placebo Comparator group

Description:

Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit..

Treatment:

Drug: Placebo

Device: CELLECTRA™ 2000