Lassa Fever
Conditions
Interventions
Sponsors
Inovio Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion 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
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 of 30dB or greater for any frequency tested between 500 Hz - 8000Hz; 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 PI feels is contraindicated to clinical trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) ;Number of Participants with Injection Site Reactions;Number of Participants with Adverse Events of Special Interest (AESIs);Change from Baseline in Antigen Specific Binding Antibody titers;Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Interferon-Gamma Response Magnitude | — |
Countries
Ghana
Contacts
Public ContactSusan;Kwadwo Adu Amankwah;Koram
Noguchi Memorial Institute for Medical Research;Noguchi Memorial Institute for Medical Research
Outcome results
None listed