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

Sponsor
Inovio Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04093076
Collaborator
Coalition for Epidemic Preparedness Innovations (Other)
220
Enrollment
1
Location
4
Arms
19.1
Anticipated Duration (Months)
11.5
Patients Per Site Per Month

Study Details

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 27, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) [Baseline up to Week 48]

    2. Number of Participants with Injection Site Reactions [Day 0 up to Week 48]

    3. Number of Participants with Adverse Events of Special Interest (AESIs) [Baseline up to Week 48]

    4. Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies [Day 0 up to Week 48]

    5. Change from Baseline in Lassa virus (LASV) Neutralization Assays [Day 0 up to Week 48]

    6. Change from Baseline in Interferon-Gamma Response Magnitude [Day 0 up to Week 48]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inovio Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04093076
    Other Study ID Numbers:
    • LSV-002
    First Posted:
    Sep 17, 2019
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Inovio Pharmaceuticals
    Healthy volunteer
    Additional relevant MeSH terms:
    Lassa Fever

    Study Results

    No Results Posted as of Aug 19, 2022