- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805984
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
November 20, 2020 updated by: Inovio Pharmaceuticals
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64114
- The Center for Pharmaceutical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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
|
INO-4500 will be administered ID on Day 0 and Week 4.
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
|
Placebo will be administered ID on Day 0 and Week 4.
Other Names:
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
|
INO-4500 will be administered ID on Day 0 and Week 4.
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
|
Placebo will be administered ID on Day 0 and Week 4.
Other Names:
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants with Adverse Events (AEs)
Time Frame: Baseline up to Week 48
|
Baseline up to Week 48
|
Percentage of Participants with Injection Site Reactions
Time Frame: Day 0 up to Week 48
|
Day 0 up to Week 48
|
Incidence of adverse events of special interest
Time Frame: Baseline up to Week 48
|
Baseline up to Week 48
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Interferon-Gamma Response Magnitude
Time Frame: Day 0 up to Week 48
|
Day 0 up to Week 48
|
Change from Baseline in Antigen Specific Binding Antibody titers
Time Frame: Day 0 up to Week 48
|
Day 0 up to Week 48
|
Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
Time Frame: Day 0 up to Week 48
|
Day 0 up to Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Mammen Mammen, MD, FACP, FIDSA, Inovio Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 9, 2019
Primary Completion (ACTUAL)
October 21, 2020
Study Completion (ACTUAL)
October 21, 2020
Study Registration Dates
First Submitted
January 14, 2019
First Submitted That Met QC Criteria
January 14, 2019
First Posted (ACTUAL)
January 16, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 23, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSV-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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