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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2024
  • participants needed
    542
  • sponsor
    Inovio Pharmaceuticals
Updated on 24 July 2022
Accepts healthy volunteers

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.

Details
Condition Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Treatment Placebo, CELLECTRA™ 2000, INO-4700
Clinical Study IdentifierNCT04588428
SponsorInovio Pharmaceuticals
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

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

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
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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