Venezuelan Equine EncephalomyelitisPhase 2VEE C-84NCT00582088
Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
A Phase 2 study testing VEE C-84 in people with Venezuelan Equine Encephalomyelitis, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination. 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 C-84
- Type of treatment
- Vaccines, 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
- Mar 2008to Dec 2021
- 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 < 1:20 before immunization.
- (females) Negative urine pregnancy test on the 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).
- Previous TC-83 vaccination
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- Up-to-date (within 1 year) physical examination/tests.
- 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.
- Any known allergies to components of the vaccine.
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- 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 C-84.
- 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 Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205 When Used as a Booster After TC-83 Primary Immunization in Healthy Adults At-Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus
The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.
Read the detailed description
Study Objectives:
Primary:
To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series
Secondary:
To assess incidence of VEE infection in C-84 boosted personnel.
- Conditions
- Venezuelan Equine Encephalomyelitis
- Being tested
- VEE C-84
- Keywords
- Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE
- Medical subject headings
- Encephalomyelitis, Venezuelan Equine, Encephalitis, Virus Diseases, Nervous System Diseases, Alphavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEE C-84Biological
Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer <1:20.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205 Receives: Biological: VEE C-84 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (ITT)
Frequency of the following adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth.
Measured: Day 28 after each booster dose
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Measured: Between Days 28 and 35 after each booster dose
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Measured: 12-15 months after booster dose
Immunogenicity: TC-83 with PRNT80 < 1:20
Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose.
Measured: Between Days 28 and 35 after each booster dose
Immunogenicity: TC-83 with PRNT80 < 1:20
Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose.
Measured: 12-15 months after vaccination
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses
Measured: After three booster doses
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose
Measured: 12- 15 months after first booster dose
Immunogenicity: PRNT80 ≥ 1:20 after 1 dose
Number of rollovers from past C-84 booster study with PRNT80
≥ 1:20 after 1 dose.
Measured: After 1 dose
Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol.
Measured: 12-15 months post dose for new C-84 Protocol
Secondary outcomes (1)
VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.
The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80
≥ 1:20.
Measured: Length of the study
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 startMar 2008
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (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
- Anthony Cardile, DO, Principal investigator, USAMRIID Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582088
- Sponsor's protocol ID
- A-14350
- Other IDs
- FY06-27
- Acronym
- VEE C-84
- 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 Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205 When Used as a Booster After TC-83 Primary Immunization in Healthy Adults At-Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus
- ClinicalTrials.gov ID
- NCT00582088
- Acronym / sponsor ID
- VEE C-84 / A-14350
- Conditions
- Venezuelan Equine Encephalomyelitis
- Keywords
- Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, 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
- Mar 2008 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (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.
The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.
Detailed description
Study Objectives:
Primary:
To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series
Secondary:
To assess incidence of VEE infection in C-84 boosted personnel.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: VEE C-84VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years old.
- VEE PRNT80 < 1:20 before immunization.
- (females) Negative urine pregnancy test on the 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 (9 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 C-84Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer <1:20. | Biological | Vaccine |
Primary outcome
Frequency of Adverse Events (ITT)
Time frame: Day 28 after each booster dose
Frequency of the following adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth.
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Time frame: Between Days 28 and 35 after each booster dose
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Time frame: 12-15 months after booster dose
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Immunogenicity: TC-83 with PRNT80 < 1:20
Time frame: Between Days 28 and 35 after each booster dose
Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose.
Immunogenicity: TC-83 with PRNT80 < 1:20
Time frame: 12-15 months after vaccination
Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose.
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses
Time frame: After three booster doses
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose
Time frame: 12- 15 months after first booster dose
Immunogenicity: PRNT80 ≥ 1:20 after 1 dose
Time frame: After 1 dose
Number of rollovers from past C-84 booster study with PRNT80 ≥ 1:20 after 1 dose.
Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol.
Time frame: 12-15 months post dose for new C-84 Protocol
1 secondary outcome
VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.
Time frame: Length of the study
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.
Anthony Cardile, DO 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 C-84 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 10 inclusion and 9 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?
Frequency of Adverse Events (ITT) (time frame: Day 28 after each booster dose). The study lists 9 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.