Venezuelan Equine EncephalomyelitisPhase 2VEENCT03531242
Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis (VEE) Vaccine as Booster Vaccine in Adults
A Phase 2 study testing 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1 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 purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84, TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in vaccinated personnel. 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?
- 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1
- 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
- Jun 2021to Dec 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Be 18 to 65 years old at time of consent
- Have received VEE TC-83 vaccine
- Have VEE plaque reduction neutralization 80% titers (PRNT80) <1:20
- If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccination administration. (Exception: documented hysterectomy or >3 years of menopause). The results must be negative. Females just agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
- Be considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for VDD vaccine.
- Sign and date the approved informed consent document and HIPAA Authorization.
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- Have in their charts:
- medical history (including concomitant medications) within 60 days of planned first administration of vaccine
- physical examination and laboratory tests within 1 year
- previous chest radiograph results and electrocardiogram
- Be medically cleared for participation by an investigator (Examinations and/or tests may be repeated at the discretion of the PI).
- Be willing to return for all follow-up visits.
- Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.
- Agree to defer blood donation for 1 year after receipt of the vaccine.
Who cannot join
- Have completed previous VEE C-84 vaccine study as a non-responder.
- Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
- Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg, prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- Have confirmed HIV infection.
- Have positive pregnancy test or be a breastfeeding female.
- Have any known allergies to components of the vaccine:
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- Neomycin sulfate
- Streptomycin
- VEE virus, inactivated
- Formaldehyde
- Eggs
- Human serum albumin
- Guinea pig heart cells
- Sodium bisulfite
- Have had a previous serious allergic reaction to guinea pigs or guinea pig products. (Subjects who have known allergies to guinea pigs but whose allergic reactions were not severe may still participate in the study but should be referred to an allergy specialist for assessment and recommendation prior to vaccination).
- Have received or plan to receive another vaccine or investigational product within 28 days of VEE vaccination.
- Have any unresolved AE resulting from a previous immunization.
- Have a medical condition that, in the judgment of the PI, would impact subject safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Special Immunizations Program/USAMRIID
Fort Deterick, Maryland, 21702
Anthony P Cardile, DO, MAJ, 301-619-8833, anthony.p.cardile.mil@mail.mil
About this study
Official title: Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, as Booster Vaccination in Adult Subjects at Risk of Exposure to VEE Virus
The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84, TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in vaccinated personnel.
Read the detailed description
Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine. Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63.
Duration of participation is 12-15 months if the subject demonstrates a PRNT80 of ≥1:20 at 1 year; if not, the vaccination procedure with C-84 will be repeated with a minimum of 28 days between doses. A maximum of four booster doses will be given in a year. If the PRNT80 titer is < 1:20 after four booster doses in any 12-month period, the subject's participation in the study will be placed on hold for 12 months; titers will be repeated at 1 year (± 30 days), and, if required, the subject will be given a booster dose of C-84 vaccine.
Safety endpoint measurements will be evaluated for all subjects receiving at least one vaccination under this protocol regardless of compliance with the protocol. Immunogenicity endpoints will be evaluated for subjects who have been vaccinated in compliance with the protocol and who have had blood for titers drawn in compliance with the protocol.
- Conditions
- Venezuelan Equine Encephalomyelitis
- Being tested
- 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1
- 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.
0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1Biological
administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine.
Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Initial Non-responders to VEE TC-83 vaccinations | Experimental | Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Receives: Biological: 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1 |
| Cohort B: Responders to TC-83 or previous C-84 vaccinations | Experimental | Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine.
Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63 Receives: Biological: 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Develop titers of >1:20
The primary immunogenicity endpoint measurements will be the percentage of per-protocol subjects who develop titers of ≥ 1:20 as determined by PRNT80 after VEE vaccination at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Measured: Month 12-15
Secondary outcomes (3)
GMT for PRNT80 Titers of Subjects at Each Scheduled Time Point
The geometric mean PRNT80 titers of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Measured: Month 12-15
Percentage of Subjects with Adverse Events (AEs) Following Vaccination
Safety will be evaluated by the nature (body system affected), type [local or systemic], severity, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of AEs for the assessment population
Measured: Month 12-15
Percentage of Subjects with Each AE Type (local or systemic)
Safety will be evaluated by the nature (body system affected), type [local or systemic], severity, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of AEs for the assessment population
Measured: Month 12-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study startJun 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects who successfully complete screening will be enrolled in the study to receive either (1) a series of booster(s) or (2) one booster vaccination(s). Each vaccination will be administered as 0.5 mL subcutaneous doses in the upper outer aspect of the arm (triceps areas)
- 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 P Cardile, DO, MAJ, Principal investigator, USAMRIID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531242
- Sponsor's protocol ID
- S-13-05
- Acronym
- VEE
- Status last verified
- Feb 2021
- First submitted
- 8 May 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossi AL. Rural epidemic encephalitis in Venezuela caused by a group A arbovirus (VEE). Prog Med Virol. 1967;9:176-203. No abstract available.
PubMed 4383416Casals J, Curnen EC, Thomas L. VENEZUELAN EQUINE ENCEPHALOMYELITIS IN MAN. J Exp Med. 1943 Jun 1;77(6):521-30. doi: 10.1084/jem.77.6.521.
PubMed 19871301Centers for Disease Control and Prevention (CDC). Venezuelan equine encephalitis--Colombia, 1995. MMWR Morb Mortal Wkly Rep. 1995 Oct 6;44(39):721-4.
PubMed 7565549Edelman R, Ascher MS, Oster CN, Ramsburg HH, Cole FE, Eddy GA. Evaluation in humans of a new, inactivated vaccine for Venezuelan equine encephalitis virus (C-84). J Infect Dis. 1979 Nov;140(5):708-15. doi: 10.1093/infdis/140.5.708.
PubMed 528788Franck PT, Johnson KM. An outbreak of Venezuelan encephalitis in man in the Panama Canal Zone. Am J Trop Med Hyg. 1970 Sep;19(5):860-5. doi: 10.4269/ajtmh.1970.19.860. No abstract available.
PubMed 5453912Hinman AR, McGowan JE Jr, Henderson BE. Venezuelan equine encephalomyelitis: surveys of human illness during an epizootic in Guatemala and El Salvador. Am J Epidemiol. 1971 Feb;93(2):130-6. doi: 10.1093/oxfordjournals.aje.a121233. No abstract available.
PubMed 5101138Johnson KM, Martin DH. Venezuelan equine encephalitis. Adv Vet Sci Comp Med. 1974;18(0):79-116. No abstract available.
PubMed 4609399Pittman PR, Makuch RS, Mangiafico JA, Cannon TL, Gibbs PH, Peters CJ. Long-term duration of detectable neutralizing antibodies after administration of live-attenuated VEE vaccine and following booster vaccination with inactivated VEE vaccine. Vaccine. 1996 Mar;14(4):337-43. doi: 10.1016/0264-410x(95)00168-z.
PubMed 8744562Rivas F, Diaz LA, Cardenas VM, Daza E, Bruzon L, Alcala A, De la Hoz O, Caceres FM, Aristizabal G, Martinez JW, Revelo D, De la Hoz F, Boshell J, Camacho T, Calderon L, Olano VA, Villarreal LI, Roselli D, Alvarez G, Ludwig G, Tsai T. Epidemic Venezuelan equine encephalitis in La Guajira, Colombia, 1995. J Infect Dis. 1997 Apr;175(4):828-32. doi: 10.1086/513978.
PubMed 9086137SANMARTIN-BARBERI C, GROOT H, OSORNO-MESA E. Human epidemic in Colombia caused by the Venezuelan equine encephalomyelitis virus. Am J Trop Med Hyg. 1954 Mar;3(2):283-93. doi: 10.4269/ajtmh.1954.3.283. No abstract available.
PubMed 13138831Weaver SC, Bellew LA, Rico-Hesse R. Phylogenetic analysis of alphaviruses in the Venezuelan equine encephalitis complex and identification of the source of epizootic viruses. Virology. 1992 Nov;191(1):282-90. doi: 10.1016/0042-6822(92)90190-z.
PubMed 1413507Young NA, Johnson KM. Antigenic variants of Venezuelan equine encephalitis virus: their geographic distribution and epidemiologic significance. Am J Epidemiol. 1969 Mar;89(3):286-307. doi: 10.1093/oxfordjournals.aje.a120942. No abstract available.
PubMed 5773424Martin DH, Eddy GA, Sudia WD, Reeves WC, Newhouse VF, Johnson KM. An epidemiologic study of Venezuelan equine encephalomyelitis in Costa Rica, 1970. Am J Epidemiol. 1972 Jun;95(6):565-78. doi: 10.1093/oxfordjournals.aje.a121426. No abstract available.
PubMed 5063895
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, as Booster Vaccination in Adult Subjects at Risk of Exposure to VEE Virus
- ClinicalTrials.gov ID
- NCT03531242
- Acronym / sponsor ID
- VEE / S-13-05
- Conditions
- Venezuelan Equine Encephalomyelitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 May 2018 (actual)
- 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 purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84, TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in vaccinated personnel.
Detailed description
Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine. Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63.
Duration of participation is 12-15 months if the subject demonstrates a PRNT80 of ≥1:20 at 1 year; if not, the vaccination procedure with C-84 will be repeated with a minimum of 28 days between doses. A maximum of four booster doses will be given in a year. If the PRNT80 titer is < 1:20 after four booster doses in any 12-month period, the subject's participation in the study will be placed on hold for 12 months; titers will be repeated at 1 year (± 30 days), and, if required, the subject will be given a booster dose of C-84 vaccine.
Safety endpoint measurements will be evaluated for all subjects receiving at least one vaccination under this protocol regardless of compliance with the protocol. Immunogenicity endpoints will be evaluated for subjects who have been vaccinated in compliance with the protocol and who have had blood for titers drawn in compliance with the protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects who successfully complete screening will be enrolled in the study to receive either (1) a series of booster(s) or (2) one booster vaccination(s). Each vaccination will be administered as 0.5 mL subcutaneous doses in the upper outer aspect of the arm (triceps areas)
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Initial Non-responders to VEE TC-83 vaccinations | Experimental | Biological: 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. |
| Cohort B: Responders to TC-83 or previous C-84 vaccinations | Experimental | Biological: 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine. Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be 18 to 65 years old at time of consent
- Have received VEE TC-83 vaccine
- Have VEE plaque reduction neutralization 80% titers (PRNT80) <1:20
- If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccination administration. (Exception: documented hysterectomy or >3 years of menopause). The results must be negative. Females just agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
- Be considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for VDD vaccine.
Key exclusion criteria (18 listed)
- Have completed previous VEE C-84 vaccine study as a non-responder.
- Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
- Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg, prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- Have confirmed HIV infection.
- Have positive pregnancy test or be a breastfeeding female.
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 |
|---|---|---|
| 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine. Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63 | Biological | Cohort A: Initial Non-responders to VEE TC-83 vaccinations, Cohort B: Responders to TC-83 or previous C-84 vaccinations |
Primary outcome
Percentage of Subjects Who Develop titers of >1:20
Time frame: Month 12-15
The primary immunogenicity endpoint measurements will be the percentage of per-protocol subjects who develop titers of ≥ 1:20 as determined by PRNT80 after VEE vaccination at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
3 secondary outcomes
GMT for PRNT80 Titers of Subjects at Each Scheduled Time Point
Time frame: Month 12-15
Percentage of Subjects with Adverse Events (AEs) Following Vaccination
Time frame: Month 12-15
Percentage of Subjects with Each AE Type (local or systemic)
Time frame: Month 12-15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 4383416Rossi AL. Rural epidemic encephalitis in Venezuela caused by a group A arbovirus (VEE). Prog Med Virol. 1967;9:176-203. No abstract available.
- Background: PubMed 19871301Casals J, Curnen EC, Thomas L. VENEZUELAN EQUINE ENCEPHALOMYELITIS IN MAN. J Exp Med. 1943 Jun 1;77(6):521-30. doi: 10.1084/jem.77.6.521.
- Background: PubMed 7565549Centers for Disease Control and Prevention (CDC). Venezuelan equine encephalitis--Colombia, 1995. MMWR Morb Mortal Wkly Rep. 1995 Oct 6;44(39):721-4.
- Background: PubMed 528788Edelman R, Ascher MS, Oster CN, Ramsburg HH, Cole FE, Eddy GA. Evaluation in humans of a new, inactivated vaccine for Venezuelan equine encephalitis virus (C-84). J Infect Dis. 1979 Nov;140(5):708-15. doi: 10.1093/infdis/140.5.708.
- Background: PubMed 5453912Franck PT, Johnson KM. An outbreak of Venezuelan encephalitis in man in the Panama Canal Zone. Am J Trop Med Hyg. 1970 Sep;19(5):860-5. doi: 10.4269/ajtmh.1970.19.860. No abstract available.
- Background: PubMed 5101138Hinman AR, McGowan JE Jr, Henderson BE. Venezuelan equine encephalomyelitis: surveys of human illness during an epizootic in Guatemala and El Salvador. Am J Epidemiol. 1971 Feb;93(2):130-6. doi: 10.1093/oxfordjournals.aje.a121233. No abstract available.
- Background: PubMed 4609399Johnson KM, Martin DH. Venezuelan equine encephalitis. Adv Vet Sci Comp Med. 1974;18(0):79-116. No abstract available.
- Background: PubMed 8744562Pittman PR, Makuch RS, Mangiafico JA, Cannon TL, Gibbs PH, Peters CJ. Long-term duration of detectable neutralizing antibodies after administration of live-attenuated VEE vaccine and following booster vaccination with inactivated VEE vaccine. Vaccine. 1996 Mar;14(4):337-43. doi: 10.1016/0264-410x(95)00168-z.
- Background: PubMed 9086137Rivas F, Diaz LA, Cardenas VM, Daza E, Bruzon L, Alcala A, De la Hoz O, Caceres FM, Aristizabal G, Martinez JW, Revelo D, De la Hoz F, Boshell J, Camacho T, Calderon L, Olano VA, Villarreal LI, Roselli D, Alvarez G, Ludwig G, Tsai T. Epidemic Venezuelan equine encephalitis in La Guajira, Colombia, 1995. J Infect Dis. 1997 Apr;175(4):828-32. doi: 10.1086/513978.
- Background: PubMed 13138831SANMARTIN-BARBERI C, GROOT H, OSORNO-MESA E. Human epidemic in Colombia caused by the Venezuelan equine encephalomyelitis virus. Am J Trop Med Hyg. 1954 Mar;3(2):283-93. doi: 10.4269/ajtmh.1954.3.283. No abstract available.
- Background: PubMed 1413507Weaver SC, Bellew LA, Rico-Hesse R. Phylogenetic analysis of alphaviruses in the Venezuelan equine encephalitis complex and identification of the source of epizootic viruses. Virology. 1992 Nov;191(1):282-90. doi: 10.1016/0042-6822(92)90190-z.
- Background: PubMed 5773424Young NA, Johnson KM. Antigenic variants of Venezuelan equine encephalitis virus: their geographic distribution and epidemiologic significance. Am J Epidemiol. 1969 Mar;89(3):286-307. doi: 10.1093/oxfordjournals.aje.a120942. No abstract available.
- Individual participant dataSharing planned: No
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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.
Anthony P Cardile, DO, MAJ principal investigator
USAMRIID
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 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1 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 14 inclusion and 18 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: opening soon, as of the sponsor's last update on 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony P Cardile, DO, MAJ (301-619-8833, anthony.p.cardile.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Who Develop titers of >1:20 (time frame: Month 12-15). 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 NCT03531242, which also lists 13 linked publications.
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 16 Feb 2021.