Healthy Volunteers - MERS COV Vaccine
Conditions
Interventions
INO4700 followed by Electroporation
Sponsors
Inovio Pharmaceuticals Inc
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; Able and willing to comply with all study procedures; Screening laboratory results within normal limits; 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); Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 1 month 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 1 month following last dose; History of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) or chronic bronchitis; 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 the prevention of MERS or severe acute respiratory syndrome (SARS); Prior exposure to MERS-CoV or camels; Participants who participate in MERS-201 Part 1 cannot participate in MERS-201 Part 2; Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles; Prisoner or participants who are compulsorily detained (involuntary incarceration); Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic corticosteroids must be discontinued at least 3 months prior to first dose; Reported active drug or alcohol or substance abuse or dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Adverse Events in Part 1;Percentage of Participants with Adverse Events in Part 1;Frequency of Injection Site Reactions in Part 1;Percentage of Participants with injection Site Reactions in Part 1;Frequency of Adverse Events of Special Interest (AESIs) in Part 1;Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1;Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1;Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1;Percentage Antigen Specific Cellular Immune Response in Part 1;Percentage of Seroconverted Participants in Part 1;Percentage of Participants with Overall Immune Response in Part 1;Frequency of Adverse Events in Part 2;Percentage of Participants with Adverse Events in Part 2;Frequency of Injection Site Reactions in Part 2;Percentage of Participants with Injection Site Reactions in Part 2;Frequency of Adverse Events of Special Interest (AESIs) in Part 2;Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2;Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2;Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2;Percentage Antigen Specific Celluar Immune Response in Part 2;Percentage of Seroconverted Participants in Part 2;Percentage of Participants with Overall Immune Response in Part 2 | — |
Countries
Kenya
Outcome results
None listed