- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01984983
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- 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
-
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California
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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
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 |
Intervention / Treatment |
---|---|
Experimental: VEEV DNA Vaccine 0.5 mg/ml Intramuscular
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
|
|
Experimental: VEEV DNA Vaccine 0.5 mg/ml Intradermal
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
|
|
Experimental: VEEV DNA Vaccine 2.0 mg/ml Intramuscular
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
|
|
Experimental: VEEV DNA Vaccine 2.0 mg/ml Intradermal
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
|
|
Placebo Comparator: Placebo: 0.9% saline
0.9% saline
|
What is the study measuring?
Primary Outcome Measures
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
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.
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.
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
December 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
September 23, 2013
First Submitted That Met QC Criteria
November 7, 2013
First Posted (Estimate)
November 15, 2013
Study Record Updates
Last Update Posted (Estimate)
August 26, 2015
Last Update Submitted That Met QC Criteria
August 24, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Encephalomyelitis
- Alphavirus Infections
- Togaviridae Infections
- Encephalitis
- Encephalomyelitis, Equine
- Encephalomyelitis, Venezuelan Equine
Other Study ID 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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