Back to resultsDose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Primary Purpose
Lassa Fever
Status
Completed
Phase
Phase 1
Locations
Ghana
Study Type
Interventional
Intervention
INO-4500
CELLECTRA™ 2000
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Lassa Fever focused on measuring Healthy volunteer
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);
- Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months following last dose.
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 three (3) months following last dose;
- Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing;
- 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;
- Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 Hz - 8000 Hz;
- Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
- Current or anticipated concomitant immunosuppressive therapy;
- Fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.
Sites / Locations
- Noguchi Memorial Institute for Medical Research, University of Ghana
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
INO-4500 Group A
INO-4500 Group B
Placebo Group C
Placebo Group D
Arm Description
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device.
Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit..
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events (AEs)
Number of Participants with Injection Site Reactions
Number of Participants with Adverse Events of Special Interest (AESIs)
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
Change from Baseline in Lassa virus (LASV) Neutralization Assays
Change from Baseline in Interferon-Gamma Response Magnitude
Secondary Outcome Measures
Full Information
NCT ID
NCT04093076
First Posted
September 16, 2019
Last Updated
November 18, 2022
Sponsor
Inovio Pharmaceuticals
Collaborators
Coalition for Epidemic Preparedness Innovations
1. Study Identification
Unique Protocol Identification Number
NCT04093076
Brief Title
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Official Title
Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inovio Pharmaceuticals
Collaborators
Coalition for Epidemic Preparedness Innovations
4. Oversight
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
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lassa Fever
Keywords
Healthy volunteer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INO-4500 Group A
Arm Type
Experimental
Arm Description
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device.
Arm Title
INO-4500 Group B
Arm Type
Experimental
Arm Description
Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.
Arm Title
Placebo Group C
Arm Type
Placebo Comparator
Arm Description
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.
Arm Title
Placebo Group D
Arm Type
Placebo Comparator
Arm Description
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit..
Intervention Type
Drug
Intervention Name(s)
INO-4500
Intervention Description
INO-4500 will be administered ID on Day 0 and Week 4.
Intervention Type
Device
Intervention Name(s)
CELLECTRA™ 2000
Intervention Description
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
SSC-0001
Intervention Description
Placebo will be administered ID on Day 0 and Week 4.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Time Frame
Baseline up to Week 48
Title
Number of Participants with Injection Site Reactions
Time Frame
Day 0 up to Week 48
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame
Baseline up to Week 48
Title
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
Time Frame
Day 0 up to Week 48
Title
Change from Baseline in Lassa virus (LASV) Neutralization Assays
Time Frame
Day 0 up to Week 48
Title
Change from Baseline in Interferon-Gamma Response Magnitude
Time Frame
Day 0 up to Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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);
Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months following last dose.
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 three (3) months following last dose;
Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing;
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;
Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 Hz - 8000 Hz;
Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
Current or anticipated concomitant immunosuppressive therapy;
Fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonaventure Orizu, MD
Organizational Affiliation
Inovio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Noguchi Memorial Institute for Medical Research, University of Ghana
City
Legon
State/Province
Accra
Country
Ghana
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 two (2) 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.
Learn more about this trial
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
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