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

Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Lassa Fever
• Intervention / Treatment: Drug: INO-4500; Drug: Placebo; Device: CELLECTRA® 2000

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: INO-4500 Group A; Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device	Drug: INO-4500; INO-4500 will be administered ID on Day 0 and Week 4.; Device: CELLECTRA® 2000; EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
PLACEBO_COMPARATOR: Placebo Comparator Group A; Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device	Drug: Placebo; Placebo will be administered ID on Day 0 and Week 4.; Other Names: SSC-0001; Device: CELLECTRA® 2000; EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
EXPERIMENTAL: INO-4500 Group B; Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device	Drug: INO-4500; INO-4500 will be administered ID on Day 0 and Week 4.; Device: CELLECTRA® 2000; EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
PLACEBO_COMPARATOR: Placebo Comparator Group B; Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device	Drug: Placebo; Placebo will be administered ID on Day 0 and Week 4.; Other Names: SSC-0001; Device: CELLECTRA® 2000; EP using the CELLECTRA® 2000 device will be administered following ID drug administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Adverse Events (AEs)	Baseline up to Week 48
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies	Day 0 up to Week 48

Collaborators and Investigators

• Sponsor: Inovio Pharmaceuticals
• Collaborators: Coalition for Epidemic Preparedness Innovations
• Investigators: Study Director: Mammen Mammen, MD, FACP, FIDSA, Inovio Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2019
• Primary Completion (ACTUAL): October 21, 2020
• Study Completion (ACTUAL): October 21, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (ACTUAL): January 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Healthy volunteer
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral; Arenaviridae Infections; Lassa Fever
• Other Study ID Numbers: LSV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
• IPD Sharing Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
• IPD Sharing Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes