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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 : Completed
First Posted : January 16, 2019
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE May 9, 2019
Actual Primary Completion Date October 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 48 ]
  • Percentage of Participants with Injection Site Reactions [ Time Frame: Day 0 up to Week 48 ]
  • Incidence of adverse events of special interest [ Time Frame: Baseline up to Week 48 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 68 ]
  • Percentage of Participants with Injection Site Reactions [ Time Frame: Day 0 up to Week 68 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • Change from Baseline in Antigen Specific Binding Antibody titers [ Time Frame: Day 0 up to Week 48 ]
  • Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies [ Time Frame: Day 0 up to Week 48 ]
  • Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: Day 0 up to Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Change from Baseline in Antigen Specific Binding Antibody titers [ Time Frame: Day 0 up to Week 6 ]
  • Change from Baseline in Lassa Virus (LASV) Neutralizing Antibodies [ Time Frame: Day 0 up to Week 6 ]
  • Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: Day 0 up to Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Official Title  ICMJE Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Lassa Fever
Intervention  ICMJE
  • Drug: INO-4500
    INO-4500 will be administered ID on Day 0 and Week 4.
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: INO-4500
    • Device: CELLECTRA® 2000
  • 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
    Interventions:
    • Drug: Placebo
    • Device: CELLECTRA® 2000
  • 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
    Interventions:
    • Drug: INO-4500
    • Device: CELLECTRA® 2000
  • 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
    Interventions:
    • Drug: Placebo
    • Device: CELLECTRA® 2000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 21, 2020
Actual Primary Completion Date October 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03805984
Other Study ID Numbers  ICMJE LSV-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Current Responsible Party Inovio Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inovio Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Coalition for Epidemic Preparedness Innovations
Investigators  ICMJE
Study Director: Mammen Mammen, MD, FACP, FIDSA Inovio Pharmaceuticals
PRS Account Inovio Pharmaceuticals
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP