Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine in Healthy Adults (NCT03051386) | Clinical Trial Compass
UnknownPhase 2
Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine in Healthy Adults
United States500 participantsStarted 2018-05-30
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, Live, Attenuated, dried TC-83, NDBR 102, Lot 4, Run 3, and collect data on the incidence of occupational VEE virus infection in vaccinated personnel.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Be 18-65 years old at time of consent.
ā. Have VEE virus PRNT80 \< 1:10.
ā. If female of childbearing potential, must agree to have a serum pregnancy test on the same day before vaccine administration. (Exception: documented hysterectomy or ā„ 3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the vaccination.
ā. Be considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for the VEE vaccine.
ā. Sign and date the approved informed consent document and HIPAA Authorization.
ā. Have in their charts:
ā. Be medically cleared for participation by an investigator. Examinations or tests may be repeated at the discretion of the PI.
ā. Be willing to return for all follow-up visits.
Exclusion criteria
ā. Have received VEE vaccine.
ā. Have family history (first degree relative) of diabetes mellitus (any type), a personal or family history of gestational diabetes, a confirmed elevated fasting serum glucose test (\> 125 mg/dL), or a hemoglobin A1c \> 5.6%. (At the principal investigator's discretion, a subject may participate if the family history of diabetes is only of late onset in an elderly parent.)
ā. 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).
What they're measuring
1
Safety: Occurrence of Serious Adverse Events and Adverse Events (SAEs and AEs)
Timeframe: 15 months
2
Safety: Percentage of subjects with symptoms following VEE vaccination
Timeframe: 15 months
3
Safety: Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination
Timeframe: 15 months
Trial details
NCT IDNCT03051386
SponsorU.S. Army Medical Research and Development Command
ā. 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.
ā. Have confirmed HIV infection (antibody positivity).
ā. Have a positive pregnancy test or a breastfeeding female.
ā. Have any known allergies to components of the vaccine:
ā. History of serious allergic reaction to guinea pigs or guinea pig products. (Subjects who have known allergies to guinea pigs will be evaluated. The vast majority of individuals who are allergic to guinea pigs are allergic to the dander from the animals. An individual with a past serious allergic reaction to guinea pigs will be excluded.)