Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Li… (NCT00109304) | Clinical Trial Compass
WithdrawnPhase 1
Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine
Stopped: Funding withdrawn
United States0Started 2005-07
Plain-language summary
This study is being done to determine the safety and tolerability of a new investigational vaccine referred to as VEE IA/B V3526, which may induce production of specific antibodies in vaccinated humans, and may protect them against infection with the Venezuelan Equine Encephalitis (VEE) Virus.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion Criteria:
* The volunteer is a male or female between 18 and 40 years of age (inclusive).
* The volunteer is able and willing to comply with the protocol procedures: 2-week 15 nights/ (14-day) in-patient stay and availability for follow-up visits for six months post vaccination.
* The volunteer is in good health, as determined by the Investigator following a complete medical history and physical examination, and the volunteer has had no clinically significant illness by medical history or exam (e.g., asthma, hypertension) or requiring hospitalization within the six months before vaccination in this study.
* The volunteer has the following laboratory parameters within normal range: \*total WBC, \*hemoglobin, \*platelets, \*LFT (liver function tests (AST, ALT, ALP, bilirubin) and \*negative for proteinuria. Other laboratory parameters must be within 10% of the upper or lower limits of the normal range of the Northwest Kinetics clinical laboratory and not clinically significant as assessed by the Investigator and/or Sponsor Medical Monitor.
* Female volunteers must not be pregnant or nursing, or must be of non-childbearing potential (e.g., surgically sterilized or postmenopausal). If volunteers are women of childbearing potential (WCBP), they must verbalize use of an acceptable method of contraception (i.e., hormonal contraception (injectable or oral) or intrauterine device) or abstinence for at least 30 days before and through 180 days after vaccination.
* The volunt…
What they're measuring
1
Incidence and character of adverse events considered related to the VEE IA/B V3526 vaccine
2
Level and duration of serum viremia and viral shedding in nose and/or throat
Trial details
NCT IDNCT00109304
SponsorDynPort Vaccine Company LLC, A GDIT Company