Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers - MERS-201

Inovio Pharmaceuticals, Inc.0 sites542 target enrollmentMay 16, 2023

ConditionsA (Healthy Volunteers)Healthy Coronavirus Y59.9

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: A (Healthy Volunteers)
Sponsor: Inovio Pharmaceuticals, Inc.
Enrollment: 542
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 16, 2023

End Date

February 28, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Inovio Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures;
•b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years of age;
•c. Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening. Note: Participants taking daily prescription or non\-prescription medications for management of acceptable chronic medical conditions must be on a stable dose, as defined by non\-change in dose for the 3 months prior to the first dose of study medication and no planned changes during the active dosing period of the study;
•d. Able and willing to comply with all study procedures;
•e. Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator;
•f. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening;
•g. Screening ECG deemed by the Investigator as having no clinically significant findings (e.g. Wolff\-Parkinson\-White syndrome);
•h. Must meet one of the following criteria with respect to reproductive capacity:
•? Women who are post\-menopausal as defined by spontaneous amenorrhea for \= 12 months;
•? Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at least six (6\) months prior to enrollment or tubal ligation, absence of ovaries and/or uterus in females);

Exclusion Criteria

•a.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;
•b.Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing;
•c.History of respiratory diseases such as asthma, chronic obstructive pulmonary disease or chronic bronchitis;
•d.Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
•e.Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive any vaccine during the timeframe restricted per the protocol;
•f.Previous receipt of an investigational vaccine product for prevention of MERS;
•g.Prior exposure to MERS\-CoV or camels (serology or antibody testing will be requested at the Investigator’s discretion);
•h.Participants who participated in MERS\-201 Part 1 cannot participate in MERS\-201 Part 2;
•i.Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:
•a.Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site;