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History of Changes for Study: NCT03805984
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Latest version (submitted November 20, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 14, 2019 None (earliest Version on record)
2 January 15, 2019 Arms and Interventions and Study Status
3 February 11, 2019 Study Status
4 March 4, 2019 Study Status
5 April 22, 2019 Study Status
6 May 6, 2019 Arms and Interventions, Study Design, Outcome Measures, Study Status, Eligibility and Study Description
7 May 9, 2019 Recruitment Status, Study Status and Contacts/Locations
8 June 7, 2019 Study Status
9 August 12, 2019 Study Status, Contacts/Locations, Eligibility and Outcome Measures
10 September 30, 2019 Study Status
11 November 7, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
12 November 14, 2019 Study Status and Study Design
13 December 13, 2019 Study Status
14 January 27, 2020 Study Status
15 February 27, 2020 Study Status
16 April 21, 2020 Study Status
17 June 8, 2020 Study Status
18 July 8, 2020 Study Status
19 August 10, 2020 Study Status
20 September 8, 2020 Study Status
21 October 26, 2020 Study Status
22 November 12, 2020 Recruitment Status and Study Status
23 November 20, 2020 Contacts/Locations and Study Status
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Study NCT03805984
Submitted Date:  January 14, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: LSV-001
Brief Title: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Official Title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Not yet recruiting
Study Start: January 16, 2019
Primary Completion: August 2020 [Anticipated]
Study Completion: August 2020 [Anticipated]
First Submitted: January 14, 2019
First Submitted that
Met QC Criteria:
January 14, 2019
First Posted: January 16, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
January 14, 2019
Last Update Posted: January 16, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Inovio Pharmaceuticals
Responsible Party: Sponsor
Collaborators: Coalition for Epidemic Preparedness Innovations
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is a dose finding trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adult volunteers.
Detailed Description:
Open or close this module Conditions
Conditions: Lassa Fever
Keywords: Healthy volunteer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group A
Participants will receive 2 ID injections of 0.1 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. Only the dose group judged to have the optimal response will receive a third dose at Week 48.
Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
Experimental: Group B
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. Only the dose group judged to have the optimal response will receive a third dose at Week 48.
Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
Experimental: Group C
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. Only the dose group judged to have the optimal response will receive a third dose at Week 48.
Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants with Adverse Events (AEs)
[ Time Frame: Baseline up to Week 68 ]

2. Percentage of Participants with Injection Site Reactions
[ Time Frame: Day 0 up to Week 68 ]

Secondary Outcome Measures:
1. Change from Baseline in Antigen Specific Binding Antibody titers
[ Time Frame: Day 0 up to Week 6 ]

2. Change from Baseline in Lassa Virus (LASV) Neutralizing Antibodies
[ Time Frame: Day 0 up to Week 6 ]

3. Change from Baseline in Interferon-Gamma Response Magnitude
[ Time Frame: Day 0 up to Week 6 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
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;
  • 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 6 months following last dose;
  • Administration of an investigational product within 30 days of 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;
  • Current or anticipated concomitant immunosuppressive therapy.
Open or close this module Contacts/Locations
Central Contact Person: Inovio Call Center
Telephone: (267) 440-4237
Email: clinical.trials@inovio.com
Study Officials: Scott White, MD
Study Director
Inovio Pharmaceuticals
Locations: United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Contact:Principal Investigator: John E Ervin, MD
Open or close this module IPDSharing
Plan to Share IPD: Yes
Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Information:
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.
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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