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

Primary Purpose

Lassa Fever

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

INO-4500

Placebo

CELLECTRA® 2000

About this trial

This is an interventional prevention trial for Lassa Fever focused on measuring Healthy volunteer

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

The Center for Pharmaceutical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

INO-4500 Group A

Placebo Comparator Group A

INO-4500 Group B

Placebo Comparator Group B

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 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 INO-4500 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

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs)

Percentage of Participants with Injection Site Reactions

Incidence of adverse events of special interest

Secondary Outcome Measures

Change from Baseline in Antigen Specific Binding Antibody titers

Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies

Change from Baseline in Interferon-Gamma Response Magnitude

Full Information

NCT ID

NCT03805984

First Posted

January 14, 2019

Last Updated

November 20, 2020

Sponsor

Inovio Pharmaceuticals

Collaborators

Coalition for Epidemic Preparedness Innovations

1. Study Identification

Unique Protocol Identification Number

NCT03805984

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

May 9, 2019 (Actual)

Primary Completion Date

October 21, 2020 (Actual)

Study Completion Date

October 21, 2020 (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

5. Study Description

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.

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

Sequential 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

60 (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

Placebo Comparator Group A

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

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

Arm Title

Placebo Comparator Group B

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

Intervention Type

Drug

Intervention Name(s)

INO-4500

Intervention Description

INO-4500 will be administered ID on Day 0 and Week 4.

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.

Intervention Type

Device

Intervention Name(s)

CELLECTRA® 2000

Intervention Description

EP using the CELLECTRA® 2000 device will be administered following ID drug administration.

Primary Outcome Measure Information:

Title

Percentage of Participants with Adverse Events (AEs)

Time Frame

Baseline up to Week 48

Title

Percentage of Participants with Injection Site Reactions

Time Frame

Day 0 up to Week 48

Title

Incidence of adverse events of special interest

Time Frame

Baseline up to Week 48

Secondary Outcome Measure Information:

Title

Change from Baseline in Antigen Specific Binding Antibody titers

Time Frame

Day 0 up to Week 48

Title

Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies

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

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mammen Mammen, MD, FACP, FIDSA

Organizational Affiliation

Inovio Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

The Center for Pharmaceutical Research

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

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 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.

Learn more about this trial

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

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