Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine in Healthy Adults (VEE)
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|ClinicalTrials.gov Identifier: NCT03051386|
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Venezuelan Equine Encephalomyelitis Virus Disease||Biological: VEE Vaccine||Phase 2|
This protocol is replacing NCT00582504.
The study population will consist of USAMRIID and qualified extramural participants who are at risk of exposure to VEE virus. This study will be performed at the USAMRIID SIP Clinic. This open-label study represents a continuation of previous research conducted at USAMRIID. Subjects will be vaccinated with 0.5 mL of VEE vaccine, Live, Attenuated TC-83, NDBR 102, Lot 4, Run 3 subcutaneously in the upper outer aspect of the triceps region. Subjects will contacted the following day and weekly for 4 weeks to assess for adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Live Attenuated, Dried, TC-83, NDBR 102, Lot 4, Run 3, as Primary Vaccination in Healthy Adult Subjects at Risk of Exposure to VEE Virus|
|Actual Study Start Date :||May 30, 2018|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2023|
Experimental: VEE Vaccine
0.5 mL of VEE vaccine, Live, Attenuated TC-83, NDBR 102, Lot 4, Run 3
Biological: VEE Vaccine
0.5 mL of VEE vaccine administered subcutaneously in the upper outer aspect of the triceps region.
Other Name: TC-83
- Safety: Occurrence of Serious Adverse Events and Adverse Events (SAEs and AEs) [ Time Frame: 15 months ]Collect and assess safety data for VEE vaccine
- Safety: Percentage of subjects with symptoms following VEE vaccination [ Time Frame: 15 months ]Collect and assess safety data for VEE vaccine
- Safety: Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination [ Time Frame: 15 months ]Collect and assess safety data for VEE vaccine
- Immunogenicity: Percentage of subjects who develop titers of >1:20 [ Time Frame: 15 months ]Percentage of subjects who develop titers of ≥ 1:20 as determined by PRNT80 after VEE vaccination at each scheduled time point for which blood samples are taken and over the entire study period to study completion.
- Immunogenicity: Geometric Mean PRNT80 Titers of subjects [ Time Frame: 15 months ]Geometric mean PRNT80 titers of subjects at each scheduled time point for which blood samples are taken and over the entire study period to study completion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051386
|Contact: Ronald B. Reisler, MD, MPHfirstname.lastname@example.org|
|Contact: Jason A. Regules, MD, FACP, LTCemail@example.com|
|United States, Maryland|
|Special Immunizations Program, Division of Medicine, USAMRIID||Recruiting|
|Fort Deterick, Maryland, United States, 21702|
|Contact: Ronald B. Reisler, MD, MPH 301-619-4842 firstname.lastname@example.org|
|Principal Investigator:||Ronald B. Reisler, MD, MPH||USAMRIID|