Trials Sponsors Conditions Drugs Pricing

Conditions

Ebola Vaccine

Keywords

EbolaVaccine

Outcome Measures

Primary Outcomes (1)

Safety Assessment (Composite of multiple measures: adverse events, pain (VAS), lab abnormalities, changes in vital signs)
Composite of multiple measures consist of: * Frequency and severity of all adverse events * Local pain immediately and at 5 and 10 minutes after Study Treatment/EP using a visual analog scale from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" * Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP * Frequency and severity of laboratory abnormalities * Changes in vital signs (blood pressure, heart rate, respiratory rate, temperature)
Screening through up to 60 weeks following the first dose

Secondary Outcomes (1)

Immunology Assessment
Screening and at select points up to 60 weeks following the first dose

Other Outcomes (1)

Exploratory Assessment
Screening and at select points up to 60 weeks following the first dose

Study Arms (13)

Group 1

EXPERIMENTAL

INO-4201 IM + EP, 2 mg, 3 doses

Biological: INO-4201

Group 2

EXPERIMENTAL

INO-4202 IM + EP, 2 mg, 3 doses

Biological: INO-4202

Group 3

EXPERIMENTAL

INO-4201 ID + EP 0.2A, 2 mg, 3 doses

Biological: INO-4201

Interventions

INO-4201Biological

INO-4201 delivered IM followed by Electroporation

Group 1

INO-4202Biological

INO-4202 delivered IM followed by Electroporation

Group 2

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age 18-50 years;
Able to provide consent to participate and having signed an Informed Consent Form (ICF);

Sponsors & Collaborators

GeneOne Life Science, Inc.
Industrycollaborator
Defense Advanced Research Projects Agency
US federal agencycollaborator
Inovio Pharmaceuticals

Study Sites (3)

QPS MRA

Miami, Florida, 33143, United States

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Related Publications (1)

Tebas P, Kraynyak KA, Patel A, Maslow JN, Morrow MP, Sylvester AJ, Knoblock D, Gillespie E, Amante D, Racine T, McMullan T, Jeong M, Roberts CC, Park YK, Boyer J, Broderick KE, Kobinger GP, Bagarazzi M, Weiner DB, Sardesai NY, White SM. Intradermal SynCon(R) Ebola GP DNA Vaccine Is Temperature Stable and Safely Demonstrates Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers. J Infect Dis. 2019 Jul 2;220(3):400-410. doi: 10.1093/infdis/jiz132.
PMID: 30891607RESULT

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

rocakinogene sifuplasmid

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

Scott White, MD
Inovio Pharmaceuticals
STUDY DIRECTOR

Enrollment

240 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: In Part II only (Groups 3A and 3B), the current strength of the device will be masked from the study team administering the procedure and participant. All IP assignments will be open label and unmasked.
Purpose: PREVENTION
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 8, 2015

Study Start

May 2015

Date type not reported

You may not qualify if:

Administration of an investigational compound either currently or within 30 days of first dose;
Previous receipt of an investigational product in an interventional trial for the treatment or prevention of Ebola (exceptions: verified receipt of placebo only or participation in an observational study);
History of or positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;
Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
Baseline creatinine greater than 1.5 (CKD Stage II or greater);
Chronic liver disease or cirrhosis;
Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
Prior major surgery or radiation therapy within 4 weeks of randomization;
Pregnant, breast feeding, or considering becoming pregnant;
Less than two acceptable sites exist for intramuscular or intradermal injection and EP between use of the deltoid and lateral quadriceps muscles. A site for injection/EP is not acceptable if there are tattoos, keloids or hypertrophic scars within 2 cm of the injection/EP site.
Subject has significant acute or chronic medical illness if deemed by the practitioner that electroporation treatment could negatively impact the illness
Subject has unstable or life-threatening cardiac disease (e.g. unstable angina, class 3 or higher congestive heart failure)
Subject has an acute or chronic bleeding or clotting disorder that would contraindicate IM injections or use of blood thinners (e.g. anticoagulants or antiplatelet drugs) within 2 weeks;
Subject has a cardioverter-defibrillator or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the intended deltoid injection site (unless deemed acceptable by a Cardiologist);
+9 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (13)

Group 1

Group 2

Group 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Group 4

Group 5

Group 6

Group 7

Group 8

Group 9

Group 10

Group 11

Part II: Group 3A

Part II: Group 3B

You may not qualify if:

Source record

Locations