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Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

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: NCT03805984
Recruitment Status : Active, not recruiting
First Posted : January 16, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations (CEPI)
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Study Description
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Brief Summary:
This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential 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: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
Placebo Comparator: Placebo Comparator Group A
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
 Drug: Placebo
Placebo will be administered ID on Day 0 and Week 4.
Other Name: SSC-0001

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
 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 Comparator Group B
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
 Drug: Placebo
Placebo will be administered ID on Day 0 and Week 4.
Other Name: SSC-0001

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 48 ]
  2. Percentage of Participants with Injection Site Reactions [ Time Frame: Day 0 up to Week 48 ]
  3. Incidence of adverse events of special interest [ Time Frame: Baseline up to Week 48 ]

Secondary Outcome Measures :
  1. Change from Baseline in Antigen Specific Binding Antibody titers [ Time Frame: Day 0 up to Week 48 ]
  2. Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies [ Time Frame: Day 0 up to Week 48 ]
  3. Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: Day 0 up to Week 48 ]

Eligibility Criteria
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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);
  • Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile.

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 1 month following last dose;
  • 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;
  • Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
  • Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz;
  • Recent (within 6 months) or planned travel to Lassa-endemic region;
  • Current or anticipated concomitant immunosuppressive therapy.
Contacts and Locations
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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): NCT03805984


Locations
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United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations (CEPI)
Investigators
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Study Director: ShuPing Yang, MD, PhD Inovio Pharmaceuticals
More Information
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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03805984    
Other Study ID Numbers: LSV-001
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
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 10 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
Keywords provided by Inovio Pharmaceuticals:
Healthy volunteer
Additional relevant MeSH terms:
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Lassa Fever
Arenaviridae Infections
RNA Virus Infections
Virus Diseases
Hemorrhagic Fevers, Viral