Venezuelan Equine EncephalomyelitisPhase 2VEE TC-83NCT00582504
Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
A Phase 2 study testing VEE TC-83 in people with Venezuelan Equine Encephalomyelitis, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Venezuelan Equine Encephalomyelitis
- What is being tested?
- VEE TC-83
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2022
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- VEE PRNT80 < 1:10 before immunization.
- (females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
- Actively enrolled in the SIP
- At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
- Up-to-date (within 1 year) physical examination/tests.
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- Sign and date the approved informed consent.
- Willing to return for all follow-up visits.
- Agree to report adverse event (AE) up to 28 days after vaccination.
Who cannot join
- Over age of 65 years.
- Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
- History of immunodeficiency or current treatment with immunosuppressive medication.
- (females) Currently breastfeeding.
- Confirmed human immunodeficiency virus (HIV) titer.
- Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (> 125 mg/dL).
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- Serious allergic reaction to guinea pigs/guinea pig products.
- Any known allergies to components of the vaccine.
- A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).
- Administration of any vaccine within 28 days of TC-83.
- Any unresolved AEs resulting from a previous immunization.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, 21702
About this study
Official title: A Phase 2 Open-Label, Safety and Immunogenicity Study of a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus
This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).
- Conditions
- Venezuelan Equine Encephalomyelitis
- Being tested
- VEE TC-83
- Keywords
- Encephalitis,VEE
- 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.
VEE TC-83Biological
Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm
| Study group | Role | What they receive |
|---|---|---|
| Vaccination | Experimental | VEE TC-83 Receives: Biological: VEE TC-83 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
Measured: 21-35 days, 42-56 days, 12-15 months
Number of adverse events.
Measured: 7 years
Secondary outcomes (1)
Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venezuelan Equine EncephalomyelitisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ronald Reisler, MD, Principal investigator, USAMRIID Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582504
- Sponsor's protocol ID
- A-14317
- Other IDs
- FY06-26
- Acronym
- VEE TC-83
- Status last verified
- Feb 2021
- First submitted
- 19 Dec 2007
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label, Safety and Immunogenicity Study of a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus
- ClinicalTrials.gov ID
- NCT00582504
- Acronym / sponsor ID
- VEE TC-83 / A-14317
- Conditions
- Venezuelan Equine Encephalomyelitis
- Keywords
- Encephalitis,VEE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Sep 2007 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 28 Dec 2007 (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.
This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination | Experimental | Biological: VEE TC-83VEE TC-83 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years old
- VEE PRNT80 < 1:10 before immunization.
- (females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
- Actively enrolled in the SIP
- At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
Key exclusion criteria (11 listed)
- Over age of 65 years.
- Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
- History of immunodeficiency or current treatment with immunosuppressive medication.
- (females) Currently breastfeeding.
- Confirmed human immunodeficiency virus (HIV) titer.
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 |
|---|---|---|
| VEE TC-83Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm | Biological | Vaccination |
Primary outcome
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
Time frame: 21-35 days, 42-56 days, 12-15 months
Number of adverse events.
Time frame: 7 years
1 secondary outcome
Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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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.
Ronald Reisler, MD principal investigator
USAMRIID Medical Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VEE TC-83 in people with Venezuelan Equine Encephalomyelitis, run by U.S. Army Medical Research and Development Command 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Feb 2021. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80) (time frame: 21-35 days, 42-56 days, 12-15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2021.