Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- INO-4500
- Conditions
- Lassa Fever
- Sponsor
- Inovio Pharmaceuticals
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of Participants with Injection Site Reactions
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
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);
- •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.
Arms & Interventions
INO-4500 Group A
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Intervention: INO-4500
INO-4500 Group A
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Intervention: CELLECTRA® 2000
Placebo Comparator Group A
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
Intervention: Placebo
Placebo Comparator Group A
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
Intervention: CELLECTRA® 2000
INO-4500 Group B
Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Intervention: INO-4500
INO-4500 Group B
Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Intervention: CELLECTRA® 2000
Placebo Comparator Group B
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
Intervention: Placebo
Placebo Comparator Group B
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
Intervention: CELLECTRA® 2000
Outcomes
Primary Outcomes
Percentage of Participants with Injection Site Reactions
Time Frame: Day 0 up to Week 48
Incidence of adverse events of special interest
Time Frame: Baseline up to Week 48
Percentage of Participants with Adverse Events (AEs)
Time Frame: Baseline up to Week 48
Secondary Outcomes
- Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies(Day 0 up to Week 48)
- Change from Baseline in Interferon-Gamma Response Magnitude(Day 0 up to Week 48)
- Change from Baseline in Antigen Specific Binding Antibody titers(Day 0 up to Week 48)