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

Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 1

Contacts and Locations

Study Locations

• Ghana
  • Accra
    • Legon, Accra, Ghana
      • Noguchi Memorial Institute for Medical Research, University of Ghana

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);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• 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.
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 in two acceptable locations in two different limbs at each dosing visit.	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 Group C; Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.	Device: CELLECTRA™ 2000; EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.; Drug: Placebo; Placebo will be administered ID on Day 0 and Week 4.; Other Names: SSC-0001
PLACEBO_COMPARATOR: 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..	Device: CELLECTRA™ 2000; EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.; Drug: Placebo; Placebo will be administered ID on Day 0 and Week 4.; Other Names: SSC-0001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events (AEs)	Baseline up to Week 48
Number of Participants with Injection Site Reactions	Day 0 up to Week 48
Number of Participants with Adverse Events of Special Interest (AESIs)	Baseline up to Week 48
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies	Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralization Assays	Day 0 up to Week 48
Change from Baseline in Interferon-Gamma Response Magnitude	Day 0 up to Week 48

Collaborators and Investigators

• Sponsor: Inovio Pharmaceuticals
• Collaborators: Coalition for Epidemic Preparedness Innovations

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2021
• Primary Completion (ACTUAL): October 14, 2022
• Study Completion (ACTUAL): October 14, 2022

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (ACTUAL): September 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

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-002

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 two (2) 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
• product manufactured in and exported from the U.S.: Yes