NCT02464670

Brief Summary

This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well tolerated and immunogenic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2018

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

3.1 years

First QC Date

May 28, 2015

Last Update Submit

June 26, 2019

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

Group 4

EXPERIMENTAL

INO-4212 IM + EP, 4 mg, 3 doses

Biological: INO-4212

Group 5

EXPERIMENTAL

INO-4212 + INO-9012 IM + EP, 4+1 mg, 3 doses

Biological: INO-4212 + INO-9012

Group 6

EXPERIMENTAL

INO-4201 ID + EP 0.2A, 1 mg, 3 doses

Biological: INO-4201

Group 7

EXPERIMENTAL

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

Biological: INO-4201

Group 8

EXPERIMENTAL

INO-4201 ID + EP 0.2A, 1 mg, 2 doses

Biological: INO-4201

Group 9

EXPERIMENTAL

INO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 3 doses

Biological: INO-4201 + INO-9012

Group 10

EXPERIMENTAL

INO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 2 doses

Biological: INO-4201 + INO-9012

Group 11

EXPERIMENTAL

INO-4201 + INO-9012 ID + EP 0.2A, 0.8 + 0.2 mg, 3 doses

Biological: INO-4201 + INO-9012

Part II: Group 3A

EXPERIMENTAL

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

Biological: INO-4201

Part II: Group 3B

EXPERIMENTAL

INO-4201 ID + EP 0.1A, 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
INO-4212BIOLOGICAL

INO-4212 delivered IM followed by Electroporation

Group 4
INO-4212 + INO-9012BIOLOGICAL

INO-4212 + INO-9012 delivered IM followed by Electroporation

Group 5
INO-4201 + INO-9012BIOLOGICAL

INO-4201 + INO-9012 delivered ID followed by Electroporation

Group 10Group 11Group 9

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);
  • Able and willing to comply with all study procedures;
  • Women of child-bearing potential who are in a relationship that could result in pregnancy agree to either remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection; OR, sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or unable to become pregnant;
  • Normal screening ECG or screening ECG with no clinically significant findings;
  • Screening laboratory (Complete blood count (CBC), serum electrolytes, blood urea nitrogen (BUN), creatinine (Cr), glucose, ALT, CPK, urinalysis) grade 0-1 within 30 days prior to administration of study treatment;
  • No history of clinically significant immunosuppressive or autoimmune disease.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

QPS MRA

Miami, Florida, 33143, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

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 1, 2015

Primary Completion

May 24, 2018

Study Completion

May 24, 2018

Last Updated

June 28, 2019

Record last verified: 2019-06

Locations

US(3)