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

NCT04093076 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: LSV-002
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Lassa Fever

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

INO-4500 Group A

EXPERIMENTAL

Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device.

Drug: INO-4500; Device: CELLECTRA™ 2000

INO-4500 Group B

EXPERIMENTAL

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; Device: CELLECTRA™ 2000

Placebo Group C

PLACEBO COMPARATOR

Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.

Device: CELLECTRA™ 2000; Drug: Placebo

Placebo Group D

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

INO-4500 DRUG

INO-4500 will be administered ID on Day 0 and Week 4.

INO-4500 Group A; INO-4500 Group B

CELLECTRA™ 2000 DEVICE

EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.

INO-4500 Group A; INO-4500 Group B; Placebo Group C; Placebo Group D

Placebo DRUG

Placebo will be administered ID on Day 0 and Week 4.

Also known as: SSC-0001

Placebo Group C; Placebo Group D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (1)

Noguchi Memorial Institute for Medical Research, University of Ghana

Legon, Accra, Ghana

Location

Related Publications (1)

• Koram KA, Walker KA, Orizu B, Marrero I, Boyer J, Yang S, Broderick KE, Kusi KA, Kyei-Baafour E, Ofori EA, Pobee A, Adu-Amankwah S, Amoakoh-Coleman M, Amoakoh HB, Abuaku B, Badji E, Ntiri M, Quaye L, Morrow MP, Sylvester AJ, Reuschel EL, Gillespie E, Liebowitz D, Humeau LM. Safety, tolerability, and immunogenicity of INO-4500, a synthetic DNA-based vaccine against Lassa virus, in a phase 1b clinical trial in healthy Ghanaian adults. Front Immunol. 2025 Oct 24;16:1658549. doi: 10.3389/fimmu.2025.1658549. eCollection 2025.

  PMID: 41208990 DERIVED

MeSH Terms

Conditions

Lassa Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• Bonaventure Orizu, MD

  Inovio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 17, 2019
• Study Start: January 27, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

GH (1)