Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V

Preventive Therapy Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plague
• Pneumonic Plague
• Preventive Therapy

• NCT number: NCT00097396
• Study type: Interventional
• Source: DynPort Vaccine Company LLC, A CSC Company
• Status: Completed
• Phase: Phase 1
• Start date: November 2004
• Completion date: September 2006