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

Lassa Fever Clinical Trial

Official title:

Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805984
• Other study ID #: LSV-001
• Status: Completed
• Phase: Phase 1
• Start date: May 9, 2019
• Est. completion date: October 21, 2020

Study information

• Verified date: November 2020
• Source: Inovio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lassa Fever

Intervention

Drug:
• INO-4500
INO-4500 will be administered ID on Day 0 and Week 4.
• Placebo
Placebo will be administered ID on Day 0 and Week 4.

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

Locations

Country	Name	City	State
United States	The Center for Pharmaceutical Research	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Inovio Pharmaceuticals	Coalition for Epidemic Preparedness Innovations (CEPI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)		Baseline up to Week 48
Primary	Percentage of Participants with Injection Site Reactions		Day 0 up to Week 48
Primary	Incidence of adverse events of special interest		Baseline up to Week 48
Secondary	Change from Baseline in Antigen Specific Binding Antibody titers		Day 0 up to Week 48
Secondary	Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies		Day 0 up to Week 48
Secondary	Change from Baseline in Interferon-Gamma Response Magnitude		Day 0 up to Week 48