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

NCT ID: NCT03805984

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2020-10-21

Brief Summary

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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

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Conditions

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Lassa Fever

Keywords

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Healthy volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.

Study Groups

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INO-4500 Group A

Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device

Group Type EXPERIMENTAL

INO-4500

Intervention Type DRUG

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

CELLECTRA® 2000

Intervention Type DEVICE

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

Placebo Comparator Group A

Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered ID on Day 0 and Week 4.

CELLECTRA® 2000

Intervention Type DEVICE

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

INO-4500 Group B

Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device

Group Type EXPERIMENTAL

INO-4500

Intervention Type DRUG

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

CELLECTRA® 2000

Intervention Type DEVICE

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

Placebo Comparator Group B

Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered ID on Day 0 and Week 4.

CELLECTRA® 2000

Intervention Type DEVICE

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

Interventions

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INO-4500

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

Intervention Type DRUG

Placebo

Placebo will be administered ID on Day 0 and Week 4.

Intervention Type DRUG

CELLECTRA® 2000

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

Intervention Type DEVICE

Other Intervention Names

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SSC-0001

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coalition for Epidemic Preparedness Innovations

OTHER

Sponsor Role collaborator

Inovio Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mammen Mammen, MD, FACP, FIDSA

Role: STUDY_DIRECTOR

Inovio Pharmaceuticals

Locations

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The Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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LSV-001

Identifier Type: -

Identifier Source: org_study_id