Clinical Trial: Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers

Brief 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.

Detailed Summary: The Phase 1 clinical trial is designed as an open-label, single-center, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of a two-dose regimen of rF1V in healthy volunteers at four dose-levels (20 ug, 40 ug, 80 ug and 160 ug rF1V) in four sequential cohorts. The protocol was amended 26 January 2006 to recruit volunteers from Cohort 4 to participate in an Extension. Cohort 4 Extension volunteers will receive a third vaccination at day E-0. Day E-0 (-1) should not exceed Day 240 of the Phase 1 study.
Sponsor: DynPort Vaccine Company LLC, A CSC Company

Current Primary Outcome: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To evaluate immunogenicity of a two-dose schedule of rF1V vaccine when given as an IM injection at four ascending dose-levels
  • To collect and store serum samples for future immunogenicity assays (e.g. ELISA).


Original Secondary Outcome:

  • To evaluate immunogenicity of a two-dose schedule of rF1V vaccine when given as an IM injection at four ascending dose-levels
  • To collect and store serum samples for future immunogenicity assays (e.g. ELISA)


Information By: DynPort Vaccine Company LLC, A CSC Company

Dates:
Date Received: November 23, 2004
Date Started: November 2004
Date Completion:
Last Updated: June 29, 2011
Last Verified: June 2011