Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana

Lassa Fever Clinical Trial

Official title:

Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093076
• Other study ID #: LSV-002
• Status: Completed
• Phase: Phase 1
• Start date: January 27, 2021
• Est. completion date: October 14, 2022

Study information

• Verified date: November 2022
• Source: Inovio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• 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);

• 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.

Related Conditions & MeSH terms

• Lassa Fever

Intervention

Drug:
• INO-4500
INO-4500 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.

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

Locations

Country	Name	City	State
Ghana	Noguchi Memorial Institute for Medical Research, University of Ghana	Legon	Accra

Sponsors (2)

Lead Sponsor	Collaborator
Inovio Pharmaceuticals	Coalition for Epidemic Preparedness Innovations

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)		Baseline up to Week 48
Primary	Number of Participants with Injection Site Reactions		Day 0 up to Week 48
Primary	Number of Participants with Adverse Events of Special Interest (AESIs)		Baseline up to Week 48
Primary	Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies		Day 0 up to Week 48
Primary	Change from Baseline in Lassa virus (LASV) Neutralization Assays		Day 0 up to Week 48
Primary	Change from Baseline in Interferon-Gamma Response Magnitude		Day 0 up to Week 48