Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers

August 24, 2015 updated by: Ichor Medical Systems Incorporated

A Phase I, Randomized, Observer-blind, Placebo Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered Intramuscularly or Intradermally by Electroporation to Healthy Adults

The Phase I study will assess the basic safety, tolerability, and immunogenicity of a DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will comprise evaluation of intradermal or intramuscular administration by electroporation. Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0 mg/ml) for each route of administration. Electroporation will be administered using the TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional group of subjects will serve as a placebo control, receiving injections of saline with electroporation. The overall goal of this study will be to determine if further human clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection of dose and route of administration for future studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92108
        • Accelovance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult male or non-pregnant, non-lactating female, ages 18-49 (inclusive) at time of screening
  • Have provided written informed consent before screening
  • Free of clinically significant health problems or clinical lab abnormalities, as determined by pertinent medical history, lab evaluations, and clinical examination before entry into the study
  • Available and able to participate for all study visits and procedures
  • If sexually active, known to be at least 1 year post-menopausal, or willing to use an effective method of contraception (e.g., birth control pill, diaphragm, cervical cap, intrauterine device, condom, anatomical sterility [self or partner]) from the date of screening until at least 6 months after the last injection
  • Negative VEEV IgG antibody test result at screening (ELISA)

Exclusion Criteria:

  • History or serologic evidence of prior infection with VEE virus or prior participation in a VEE virus vaccine trial
  • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
  • History of Guillain-Barre Syndrome
  • Ongoing participation in another clinical trial
  • Receipt or planned receipt of any experimental or licensed vaccine, except for a licensed seasonal influenza vaccine, within the period 30 days prior to initial injection through 60 days after the Day 70 follow-up. (~ 6 month period in total)
  • Receipt or planned receipt of any allergy treatments involving antigen injections within the period 30 days prior to the first injection through the period 60 days after Study Day 70 (~6 month period in total)
  • Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for the eligible injection sites (left and right medial deltoid region) exceeds 40 mm
  • Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
  • Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
  • Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, EKG, and/or laboratory screening test
  • Pregnant or lactating female, or female who intends to become pregnant during the study period
  • Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
  • Administration of chronic (defined as more than 14 days) immunosuppressant's or other immune-modifying drugs within 6 months of study entry
  • For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day; Inhaled and topical steroids are allowed
  • Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
  • Syncopal episode within 12 months of screening
  • Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV (Diagnostic and Statistical Manual of Mental Disorders-4th edition)
  • Chronic or active illicit and/or intravenous drug use by history
  • Unwilling to allow storage and use of blood for future alphavirus-related research
  • Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VEEV DNA Vaccine 0.5 mg/ml Intramuscular
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Experimental: VEEV DNA Vaccine 0.5 mg/ml Intradermal
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Experimental: VEEV DNA Vaccine 2.0 mg/ml Intramuscular
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Experimental: VEEV DNA Vaccine 2.0 mg/ml Intradermal
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Placebo Comparator: Placebo: 0.9% saline
0.9% saline
Other: 0.9% saline placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The nature, frequency, and severity of local and systemic adverse events or serious adverse events associated with electroporation-based administration of the VEEV DNA vaccine candidate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The frequency, magnitude, and duration of serum anti-VEEV antibody responses
Time Frame: 12 months
Anti-VEEV immune response will be assessed by 80% Plaque Reducing Neutralization Test (PRNT80). PRNT80 titers of >= 1:10 will constitute a response.
12 months
Response to a questionnaire based assessment of acute procedure tolerability.
Time Frame: 8 weeks
Immediately following procedure administration, subjects will complete a Visual Analog Scale (VAS) based questionnaire to assess procedure tolerability.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ichor Medical Systems Incorporated

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
US Army Medical Research Institute of Infectious Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMS-VEEV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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