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Ebola VaccinePhase 1NCT02464670

Open-Label Study of INO-4212 With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers

A Phase 1 study testing INO-4201, INO-4202 and INO-4212 in people with Ebola Vaccine, run by Inovio Pharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Ebola Vaccine
What is being tested?
INO-4201, INO-4202 and INO-4212
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
3 sitesUnited States
Study dates
May 2015to 24 May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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);
  • Subject has metal implant or implantable medical device within the electroporation area;
  • Administration of any vaccine within 4 weeks of first dose;
  • Administration of any blood product within 3 months of first dose;
  • Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, or low-dose methotrexate). Systemic corticosteroids must be discontinued at least 4 weeks prior to first dose;
  • Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
  • Active military service personnel;
  • Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or
  • Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • QPS MRA

    Miami, Florida, 33143

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of INO-4212 and Its Components, INO-4201 and INO-4202, Given With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers

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.

Read the detailed description

This study will test the safety, tolerability, and immunogenicity of the DNA vaccine, INO-4212 and its components INO-4201 and INO-4202 in healthy volunteers. INO-4201 contains the DNA sequence that codes for past Ebola Zaire virus outbreak strains, and INO-4202 contains the DNA sequence that codes for the current Ebola virus outbreak strain. When given together, the DNA vaccine is called INO-4212 and contains the DNA sequence of both the previous and the current outbreak strain. Another ingredient called INO-9012 which contains the DNA sequence for interleukin-12, will be given in a subset of subjects to help boost the body's immune response when given with the vaccine.

Following administration of vaccine, a specialized medical device, CELLECTRA®, will deliver brief electrical pulses in a process known as electroporation (EP), to help move more DNA into cells more efficiently. The study will evaluate whether INO-4212 and its components may be able to generate protective immunity against Ebola Zaire, evaluate the relative ability of IM versus ID administration to elicit immune responses and evaluate whether vaccine administered with INO-9012 can generate greater immune responses.

The Ebola vaccine under study will be tested in approximately 240 healthy adult volunteers.

Conditions
Ebola Vaccine
Being tested
INO-4201, INO-4202, INO-4212, INO-4212 + INO-9012, INO-4201 + INO-9012
Keywords
Ebola, Vaccine
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INO-4201Biological

    INO-4201 delivered IM followed by Electroporation

  • INO-4202Biological

    INO-4202 delivered IM followed by Electroporation

  • INO-4201Biological

    INO-4201 delivered ID followed by Electroporation

  • INO-4212Biological

    INO-4212 delivered IM followed by Electroporation

  • INO-4212 + INO-9012Biological

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

  • INO-4201 + INO-9012Biological

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

Study groups in NCT02464670
Study groupRoleWhat they receive
Group 1ExperimentalINO-4201 IM + EP, 2 mg, 3 doses
Receives: Biological: INO-4201
Group 2ExperimentalINO-4202 IM + EP, 2 mg, 3 doses
Receives: Biological: INO-4202
Group 3ExperimentalINO-4201 ID + EP 0.2A, 2 mg, 3 doses
Receives: Biological: INO-4201
Group 4ExperimentalINO-4212 IM + EP, 4 mg, 3 doses
Receives: Biological: INO-4212
Group 5ExperimentalINO-4212 + INO-9012 IM + EP, 4+1 mg, 3 doses
Receives: Biological: INO-4212 + INO-9012
Group 6ExperimentalINO-4201 ID + EP 0.2A, 1 mg, 3 doses
Receives: Biological: INO-4201
Group 7ExperimentalINO-4201 ID + EP 0.2A, 2 mg, 2 doses
Receives: Biological: INO-4201
Group 8ExperimentalINO-4201 ID + EP 0.2A, 1 mg, 2 doses
Receives: Biological: INO-4201
Group 9ExperimentalINO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 3 doses
Receives: Biological: INO-4201 + INO-9012
Group 10ExperimentalINO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 2 doses
Receives: Biological: INO-4201 + INO-9012
Group 11ExperimentalINO-4201 + INO-9012 ID + EP 0.2A, 0.8 + 0.2 mg, 3 doses
Receives: Biological: INO-4201 + INO-9012
Part II: Group 3AExperimentalINO-4201 ID + EP 0.2A, 2 mg, 3 doses
Receives: Biological: INO-4201
Part II: Group 3BExperimentalINO-4201 ID + EP 0.1A, 2 mg, 3 doses
Receives: Biological: INO-4201

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Screening through up to 60 weeks following the first dose

Secondary outcomes (1)

  1. Immunology Assessment

    Composite outcome measure consisting of multiple measures, including:

    • Breadth and magnitude of antigen specific ELISA
    • Breadth and magnitude of neutralizing antibodies
    • Breadth and magnitude of antigen specific cellular immune responses as determined by
    • Interferon-gamma (IFN-γ) ELISpot
    • Intracellular Cytokine Staining (CTL phenotype, Lytic granule loading, Granzyme B killing of target cells)

    Measured: Screening and at select points up to 60 weeks following the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completion24 May 2018
  4. Study completion24 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02464670
Sponsor's protocol ID
EBOV-001
Status last verified
Jun 2019
First submitted
28 May 2015
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30891607

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INO-4201, INO-4202 and INO-4212 in people with Ebola Vaccine, run by Inovio Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Assessment (Composite of multiple measures: adverse events, pain (VAS), lab abnormalities, changes in vital signs) (time frame: Screening through up to 60 weeks following the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02464670, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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