Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers
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
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 26, 2015
August 1, 2015
6 months
September 23, 2013
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (2)
The frequency, magnitude, and duration of serum anti-VEEV antibody responses
12 months
Response to a questionnaire based assessment of acute procedure tolerability.
8 weeks
Study Arms (5)
VEEV DNA Vaccine 0.5 mg/ml Intramuscular
EXPERIMENTALVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate
VEEV DNA Vaccine 0.5 mg/ml Intradermal
EXPERIMENTALVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate
VEEV DNA Vaccine 2.0 mg/ml Intramuscular
EXPERIMENTALVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate
VEEV DNA Vaccine 2.0 mg/ml Intradermal
EXPERIMENTALVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate
Placebo: 0.9% saline
PLACEBO COMPARATOR0.9% saline
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Accelovance
San Diego, California, 92108, United States
Related Publications (1)
Hannaman D, Dupuy LC, Ellefsen B, Schmaljohn CS. A Phase 1 clinical trial of a DNA vaccine for Venezuelan equine encephalitis delivered by intramuscular or intradermal electroporation. Vaccine. 2016 Jun 30;34(31):3607-12. doi: 10.1016/j.vaccine.2016.04.077. Epub 2016 May 17.
PMID: 27206386DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2013
First Posted
November 15, 2013
Study Start
December 1, 2013
Primary Completion
June 1, 2014
Study Completion
May 1, 2015
Last Updated
August 26, 2015
Record last verified: 2015-08