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

• ClinicalTrials.gov Identifier: NCT03805984
• Recruitment Status: Completed
• First Posted: January 16, 2019
• Last Update Posted: November 23, 2020
• Sponsor: Inovio Pharmaceuticals
• Collaborator: Coalition for Epidemic Preparedness Innovations
• Information provided by (Responsible Party): Inovio Pharmaceuticals

Tracking Information

• First Submitted Date: January 14, 2019
• First Posted Date: January 16, 2019
• Last Update Posted Date: November 23, 2020
• Actual Study Start Date: May 9, 2019
• Actual Primary Completion Date: October 21, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 1

Study Design

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: Lassa Fever

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 14, 2019): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 21, 2020
• Actual Primary Completion Date: October 21, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03805984
• Other Study ID Numbers: 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

• 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: Inovio Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Coalition for Epidemic Preparedness Innovations

Investigators

• Study Director: Mammen Mammen, MD, FACP, FIDSA; Inovio Pharmaceuticals

• PRS Account: Inovio Pharmaceuticals
• Verification Date: November 2020