Venezuelan Equine Encephalomyelitis Clinical Trial
— VEEOfficial 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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. - 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. Exclusion Criteria: - 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: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Special Immunizations Program/USAMRIID | Fort Deterick | Maryland |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Development Command |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Month 12-15 | |
Secondary | 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. | Month 12-15 | |
Secondary | 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 | Month 12-15 | |
Secondary | 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 | Month 12-15 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00582504 -
Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
|
Phase 2 | |
Active, not recruiting |
NCT00582088 -
Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
|
Phase 2 |