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

NCT03805984 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: LSV-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lassa Fever

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants with Adverse Events (AEs)

  Baseline up to Week 48

• Percentage of Participants with Injection Site Reactions

  Day 0 up to Week 48

• Incidence of adverse events of special interest

  Baseline up to Week 48

Secondary Outcomes (3)

• Change from Baseline in Antigen Specific Binding Antibody titers

  Day 0 up to Week 48

• Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies

  Day 0 up to Week 48

• Change from Baseline in Interferon-Gamma Response Magnitude

  Day 0 up to Week 48

Study Arms (4)

INO-4500 Group A

EXPERIMENTAL

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

Drug: INO-4500; Device: CELLECTRA® 2000

Placebo Comparator Group A

PLACEBO COMPARATOR

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

Drug: Placebo; Device: CELLECTRA® 2000

INO-4500 Group B

EXPERIMENTAL

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

Drug: INO-4500; Device: CELLECTRA® 2000

Placebo Comparator Group B

PLACEBO COMPARATOR

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

Drug: Placebo; Device: CELLECTRA® 2000

Interventions

INO-4500 DRUG

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

INO-4500 Group A; INO-4500 Group B

Placebo DRUG

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

Also known as: SSC-0001

Placebo Comparator Group A; Placebo Comparator Group B

CELLECTRA® 2000 DEVICE

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

INO-4500 Group A; INO-4500 Group B; Placebo Comparator Group A; Placebo Comparator Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (1)

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

MeSH Terms

Conditions

Lassa Fever

Condition Hierarchy (Ancestors)

Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Study Officials

• Mammen Mammen, MD, FACP, FIDSA

  Inovio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: May 9, 2019
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)