Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Phase 1
Completed
- Conditions
- Lassa Fever
- Interventions
- Registration Number
- NCT04093076
- Lead Sponsor
- Inovio Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group D Placebo Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.. Placebo Group C CELLECTRA™ 2000 Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device. Placebo Group C Placebo Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device. INO-4500 Group A CELLECTRA™ 2000 Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device. Placebo Group D CELLECTRA™ 2000 Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.. INO-4500 Group A INO-4500 Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device. INO-4500 Group B INO-4500 Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit. INO-4500 Group B CELLECTRA™ 2000 Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.
- Primary Outcome Measures
Name Time Method Number of Participants with Injection Site Reactions Day 0 up to Week 48 Number of Participants with Adverse Events (AEs) Baseline up to Week 48 Number of Participants with Adverse Events of Special Interest (AESIs) Baseline up to Week 48 Change from Baseline in Interferon-Gamma Response Magnitude Day 0 up to Week 48 Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies Day 0 up to Week 48 Change from Baseline in Lassa virus (LASV) Neutralization Assays Day 0 up to Week 48
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Noguchi Memorial Institute for Medical Research, University of Ghana
🇬🇭Legon, Accra, Ghana