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

• ClinicalTrials.gov Identifier: NCT04093076
• Recruitment Status: Completed
• First Posted: September 17, 2019
• Last Update Posted: November 21, 2022
• Sponsor: Inovio Pharmaceuticals
• Collaborator: Coalition for Epidemic Preparedness Innovations
• Information provided by (Responsible Party): Inovio Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lassa Fever	Drug: INO-4500; Device: CELLECTRA™ 2000; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
• Primary Purpose: Prevention
• Official Title: Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
• Actual Study Start Date: January 27, 2021
• Actual Primary Completion Date: October 14, 2022
• Actual Study Completion Date: October 14, 2022

Arms and Interventions

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 Name: 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 Name: SSC-0001

Outcome Measures

Primary Outcome Measures :

1. Number of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 48 ]
2. Number of Participants with Injection Site Reactions [ Time Frame: Day 0 up to Week 48 ]
3. Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 48 ]
4. Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies [ Time Frame: Day 0 up to Week 48 ]
5. Change from Baseline in Lassa virus (LASV) Neutralization Assays [ Time Frame: Day 0 up to Week 48 ]
6. Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: Day 0 up to Week 48 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Ghana

Noguchi Memorial Institute for Medical Research, University of Ghana

Legon, Accra, Ghana

Sponsors and Collaborators

Inovio Pharmaceuticals

Coalition for Epidemic Preparedness Innovations

Investigators

• Study Director: Bonaventure Orizu, MD; Inovio Pharmaceuticals

More Information

• Responsible Party: Inovio Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04093076
• Other Study ID Numbers: LSV-002
• First Posted: September 17, 2019
• Last Update Posted: November 21, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)
• 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.
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Inovio Pharmaceuticals:

Healthy volunteer

Additional relevant MeSH terms:

Lassa Fever; Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral