Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers

• Status: Recruiting
• Trial end date: 2024-06-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Inovio Pharmaceuticals
• Collaborators: Coalition for Epidemic Preparedness Innovations; Coalition for Epidemic Preparedness Innovations (CEPI)

Criteria

Key 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 3 months following last dose.

Key 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 3 months 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 any vaccine within 30 days preceding Day 0 or planning to receive any vaccine during the timeframe restricted per the protocol;

• Previous receipt of an investigational vaccine product for the prevention of MERS;

• 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.