Clinical trial NCT04093076: Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Official title: Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lassa Fever
Keywords: Healthy volunteer
Lead sponsor: Inovio Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Coalition for Epidemic Preparedness Innovations
First posted: 2019-09-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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);
* 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline up to Week 48
measure: Number of Participants with Injection Site Reactions
timeFrame: Day 0 up to Week 48
measure: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to Week 48
measure: Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
timeFrame: Day 0 up to Week 48
measure: Change from Baseline in Lassa virus (LASV) Neutralization Assays
timeFrame: Day 0 up to Week 48
measure: Change from Baseline in Interferon-Gamma Response Magnitude
timeFrame: Day 0 up to Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Legon
country: Ghana
facility: Noguchi Memorial Institute for Medical Research, University of Ghana
state: Accra
Study officials:
affiliation: Inovio Pharmaceuticals
name: Bonaventure Orizu, MD
role: STUDY_DIRECTOR
References: