Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V (NCT00097396) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
United States40 participantsStarted 2004-11
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion Criteria:
* The volunteer is male or female and 18 to 40 years of age (inclusive) at the time of the first dose of investigational product
* Good health as determined by screening medical history and physical examination
* The volunteer has the following laboratory parameters within normal range: total WBC, Hemoglobin, platelets, LFT (AST, ALT, ALP, Bilirubin) and/or ≤ 1+ proteinuria. Other laboratory parameters must be within 10 % of the upper or lower limits of the normal range of the University of Kentucky clinical laboratory and not clinically significant as assessed by the Investigator and/or Sponsor Medical Monitor.
* The volunteer has a normal electrocardiogram (ECG). However, if a potential volunteer is reported to have a benign ECG abnormality (e.g., sinus bradycardia) the results may be discussed with the Sponsor Medical Monitor and Covalent Medical Monitor. With the agreement of the Investigator, Covalent Medical Monitor and Sponsor Medical Monitor and documentation of the consultation in the volunteer's study record the Investigator may include the volunteer in the study.
* The volunteer is willing to have his or her blood samples stored for future plague research studies.
* The volunteer has signed the Informed Consent Form, successfully completed (at least 90 % correct) the Test of Understanding, and has signed the HIPAA authorization form.
* The volunteer agrees not to donate blood for at least 30 days following vaccination.
* The volunteer is willin…
What they're measuring
1
To evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an IM injection at four ascending dose-levels.
Trial details
NCT IDNCT00097396
SponsorDynPort Vaccine Company LLC, A GDIT Company