Clinical trial NCT03805984: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Official title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
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: 2019-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.


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);
* 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.

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Baseline up to Week 48
measure: Percentage of Participants with Injection Site Reactions
timeFrame: Day 0 up to Week 48
measure: Incidence of adverse events of special interest
timeFrame: Baseline up to Week 48
Secondary outcomes:
measure: Change from Baseline in Antigen Specific Binding Antibody titers
timeFrame: Day 0 up to Week 48
measure: Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
timeFrame: Day 0 up to Week 48
measure: Change from Baseline in Interferon-Gamma Response Magnitude
timeFrame: Day 0 up to Week 48
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
Study officials:
affiliation: Inovio Pharmaceuticals
name: Mammen Mammen, MD, FACP, FIDSA
role: STUDY_DIRECTOR
References: