Venezuelan Equine Encephalitis Virus InfectionPhase 1NCT01984983
Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers
A Phase 1 study testing Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate in people with Venezuelan Equine Encephalitis Virus Infection, run by Ichor Medical Systems Incorporated at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Venezuelan Equine Encephalitis Virus Infection
- What is being tested?
- Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to May 2015
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate, 0.9% saline placebo
- Keywords
- Venezuelan equine encephalitis virus, DNA vaccine, electroporation, intradermal, intramuscular
- Medical subject headings
- Encephalomyelitis, Venezuelan Equine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venezuelan Equine Encephalitis Virus DNA Vaccine CandidateBiological
0.9% saline placeboOther
| Study group | Role | What they receive |
|---|---|---|
| VEEV DNA Vaccine 0.5 mg/ml Intramuscular | Experimental | Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate Receives: Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| VEEV DNA Vaccine 0.5 mg/ml Intradermal | Experimental | Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate Receives: Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| VEEV DNA Vaccine 2.0 mg/ml Intramuscular | Experimental | Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate Receives: Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| VEEV DNA Vaccine 2.0 mg/ml Intradermal | Experimental | Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate Receives: Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| Placebo: 0.9% saline | Placebo comparator | 0.9% saline Receives: Other: 0.9% saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
The frequency, magnitude, and duration of serum anti-VEEV antibody responses
Anti-VEEV immune response will be assessed by 80% Plaque Reducing Neutralization Test (PRNT80). PRNT80 titers of >= 1:10 will constitute a response.
Measured: 12 months
Response to a questionnaire based assessment of acute procedure tolerability.
Immediately following procedure administration, subjects will complete a Visual Analog Scale (VAS) based questionnaire to assess procedure tolerability.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venezuelan Equine Encephalitis Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ichor Medical Systems Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984983
- Sponsor's protocol ID
- IMS-VEEV-001
- Status last verified
- Aug 2015
- First submitted
- 23 Sep 2013
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27206386
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01984983
- Acronym / sponsor ID
- IMS-VEEV-001
- Keywords
- Venezuelan equine encephalitis virus, DNA vaccine, electroporation, intradermal, intramuscular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ichor Medical Systems IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VEEV DNA Vaccine 0.5 mg/ml Intramuscular | Experimental | Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine CandidateVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| VEEV DNA Vaccine 0.5 mg/ml Intradermal | Experimental | Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine CandidateVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| VEEV DNA Vaccine 2.0 mg/ml Intramuscular | Experimental | Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine CandidateVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| VEEV DNA Vaccine 2.0 mg/ml Intradermal | Experimental | Biological: Venezuelan Equine Encephalitis Virus DNA Vaccine CandidateVenezuelan Equine Encephalitis Virus DNA Vaccine Candidate |
| Placebo: 0.9% saline | Placebo comparator | Other: 0.9% saline placebo0.9% saline |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate | Biological | VEEV DNA Vaccine 0.5 mg/ml Intradermal, VEEV DNA Vaccine 0.5 mg/ml Intramuscular, VEEV DNA Vaccine 2.0 mg/ml Intradermal, VEEV DNA Vaccine 2.0 mg/ml Intramuscular |
| 0.9% saline placebo | Other | Placebo: 0.9% saline |
Primary outcome
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
2 secondary outcomes
The frequency, magnitude, and duration of serum anti-VEEV antibody responses
Time frame: 12 months
Response to a questionnaire based assessment of acute procedure tolerability.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Derived from this study: PubMed 27206386Hannaman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate in people with Venezuelan Equine Encephalitis Virus Infection, run by Ichor Medical Systems Incorporated at 1 site 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 6 inclusion and 21 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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
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). 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 NCT01984983, 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 26 Aug 2015.