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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093076
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Inovio Pharmaceuticals

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093076


Locations
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Ghana
Noguchi Memorial Institute for Medical Research, University of Ghana
Legon, Accra, Ghana
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations
Investigators
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Study Director: Bonaventure Orizu, MD Inovio Pharmaceuticals
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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04093076    
Other Study ID Numbers: LSV-002
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 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.

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