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

Phase 1

Completed

• Conditions: Lassa Fever
• Interventions: Drug: Placebo; Drug: INO-4500; Device: CELLECTRA® 2000

• Registration Number: NCT03805984
• Lead Sponsor: Inovio Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Start: 2019-05-09
• Primary Completion: 2020-10-21
• Study Completion: 2020-10-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator Group A	Placebo	Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
INO-4500 Group B	INO-4500	Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
INO-4500 Group A	CELLECTRA® 2000	Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
INO-4500 Group A	INO-4500	Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Placebo Comparator Group B	Placebo	Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
INO-4500 Group B	CELLECTRA® 2000	Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Placebo Comparator Group A	CELLECTRA® 2000	Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
Placebo Comparator Group B	CELLECTRA® 2000	Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Injection Site Reactions	Day 0 up to Week 48
Incidence of adverse events of special interest	Baseline up to Week 48
Percentage of Participants with Adverse Events (AEs)	Baseline up to Week 48

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States