Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-03

Study Completion Date

2022-02-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure

NCT04642638

Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Disease

TERMINATED PHASE2/PHASE3

Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19

NCT04447781

Coronavirus Infection SARS-CoV 2

COMPLETED PHASE1/PHASE2

Study of the Immunogenicity, Safety and Tolerability of the Convacell Vaccine.

NCT05156723

COVID-19 Immunologic Factors Coronavirus Infections +1 more

COMPLETED PHASE1/PHASE2

Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant

NCT04368988

COVID-19

COMPLETED PHASE1/PHASE2

Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4

NCT04790851

Influenza, Human Pneumonia, Pneumococcal Covid19

COMPLETED PHASE4

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.

Coronavirus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: INO-4800

Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.

Group Type EXPERIMENTAL

INO-4800

Intervention Type DRUG

INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

CELLECTRA® 2000

Intervention Type DEVICE

EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.

Group 2: INO-4800

Participants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.

Group Type EXPERIMENTAL

INO-4800

Intervention Type DRUG

INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

CELLECTRA® 2000

Intervention Type DEVICE

EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.

Group 3: INO-4800

Participants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.

Group Type EXPERIMENTAL

INO-4800

Intervention Type DRUG

INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

CELLECTRA® 2000

Intervention Type DEVICE

EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

INO-4800

INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

Intervention Type DRUG

CELLECTRA® 2000

EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 or deemed not clinically significant by the Investigator.
* Body Mass Index of 18-30 kg/m\^2, inclusive, at screening.
* Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening.
* Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome).
* Use of medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 3 months following last dose, be post-menopausal, be surgically sterile or have a partner who is sterile.

Exclusion Criteria

* Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial from screening until 3 months following last dose.
* Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0.
* Previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
* In a current occupation with high risk of exposure to SARS-CoV-2 (e.g., health care workers or emergency response personnel having direct interactions with or providing direct care to patients).
* Current or history of the following medical conditions:

* Respiratory diseases
* Hypersensitivity or severe allergic reactions to vaccines or drugs
* Diagnosis of diabetes mellitus
* Hypertension
* Malignancy within 5 years of screening
* Cardiovascular diseases
* Immunosuppression as a result of underlying illness or treatment including:

* Primary immunodeficiencies
* Long term use (≥7 days) of oral or parenteral glucocorticoids
* Current or anticipated use of disease-modifying doses of anti-rheumatic drugs and biologic disease-modifying drugs
* History of solid organ or bone marrow transplantation
* Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease
* Fewer than two acceptable sites available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles.
* Reported smoking, vaping, or active drug, alcohol or substance abuse or dependence.
* Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes