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

NCT ID: NCT04093076

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2022-10-14

Brief Summary

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.

Conditions

Lassa Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

INO-4500 Group A

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

Group Type: EXPERIMENTAL

INO-4500

Intervention Type: DRUG

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

CELLECTRA™ 2000

Intervention Type: DEVICE

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

INO-4500 Group B

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.

Group Type: EXPERIMENTAL

INO-4500

Intervention Type: DRUG

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

CELLECTRA™ 2000

Intervention Type: DEVICE

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

Placebo Group C

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

Group Type: PLACEBO_COMPARATOR

CELLECTRA™ 2000

Intervention Type: DEVICE

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

Placebo

Intervention Type: DRUG

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

Placebo Group D

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..

Group Type: PLACEBO_COMPARATOR

CELLECTRA™ 2000

Intervention Type: DEVICE

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

Placebo

Intervention Type: DRUG

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

Interventions

INO-4500

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

Intervention Type: DRUG

CELLECTRA™ 2000

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

Intervention Type: DEVICE

Placebo

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

Intervention Type: DRUG

Other Intervention Names

SSC-0001

Eligibility 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);
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coalition for Epidemic Preparedness Innovations

OTHER

Sponsor Role: collaborator

Inovio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonaventure Orizu, MD

Role: STUDY_DIRECTOR

Inovio Pharmaceuticals

Locations

Noguchi Memorial Institute for Medical Research, University of Ghana

Legon, Accra, Ghana

Countries

Ghana

Other Identifiers

LSV-002

Identifier Type: -

Identifier Source: org_study_id