Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
NCT ID: NCT04588428
Last Updated: 2026-01-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2021-06-21
2023-01-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS
NCT04119440
A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)
NCT04758273
A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
NCT04510207
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)
NCT04383574
Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
NCT04374487
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: INO-4700 Group A
Participants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRA™ 2000 device on Day 0 and Week 4.
INO-4700
INO-4700 was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: INO-4700 Group B
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
INO-4700
INO-4700 was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: INO-4700 Group C
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
INO-4700
INO-4700 was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: INO-4700 Group D
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
INO-4700
INO-4700 was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: INO-4700 Group E
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
INO-4700
INO-4700 was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: Placebo Group F
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: Placebo Group G
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: Placebo Group H
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 1: Placebo Group I
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
Part 2: Parts 2A and 2B
Participants were planned to receive ID injection of INO-4700 based on optimal dose and regimen selection in Part 1 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4 or Week 8 and a booster dose at Week 48 (only for Part 2B participants were planned to receive a third dose).
INO-4700
INO-4700
CELLECTRA™ 2000
CELLECTRA™ 2000
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INO-4700
INO-4700 was administered ID.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.
CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
INO-4700
INO-4700
CELLECTRA™ 2000
CELLECTRA™ 2000
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Coalition for Epidemic Preparedness Innovations
OTHER
Inovio Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bonaventure Orizu, MD
Role: STUDY_DIRECTOR
Inovio Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
Irbid, , Jordan
Pharmaceutical Research Center / Jordan University of Science and Technology
Irbid, , Jordan
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
Kericho, , Kenya
Ahero Clincal Trials Unit
Kisumu, , Kenya
American University of Beirut Medical Center
Beirut, , Lebanon
Hammoud Hospital University Medical Center
Saida, , Lebanon
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Agnes JT, Marcus SA, Al-Ghraibeh SS, Al-Sweedan SA, Kosgei J, Ogutu B, Yang S, Walker KA, Orizu B, Broderick KE, Boyer J, Ramos S, Morrow MP, Kraynyak K, Sylvester AJ, Gillespie E, Liebowitz D, Humeau LM. Safety, tolerability, and immunogenicity of a DNA-based vaccine (INO-4700) against Middle East respiratory syndrome coronavirus: phase 2a study in healthy volunteers. Front Immunol. 2025 Nov 14;16:1662923. doi: 10.3389/fimmu.2025.1662923. eCollection 2025.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MERS-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.