NCT00332956

Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers

A Phase 2 (a), Dose-Blinded, Block-Randomized, Dose and Schedule Selection Study to Evaluate the Immunogenicity and Safety of the Recombinant Plague Vaccine rF1V in Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: DynPort Vaccine Company LLC, A GDIT Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 540. Selection of dosage and schedule will be based on GMCs and seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400 healthy adult volunteers will be enrolled (100 per group) in this study.

Detailed description

Primary Objective: To select a dosage and schedule of rF1V vaccine for further study based on the immune response to F1 and V antigens up to Day 210. Secondary Objectives: 1) To assess the safety of three injections of rF1V vaccine administered IM at two dosage levels. 2\) To assess the onset and duration of the humoral immune response to F1 and V antigens. 3\) To assess the humoral immune response to rF1V antigen. 4) To collect and store blood samples for future plague related research. Exploratory Objectives: To assess additional humoral immune responses to rF1V vaccine antigens.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	rFIV vaccine	rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
BIOLOGICAL	rF1V vaccine	rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
BIOLOGICAL	rF1V vaccine	rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
BIOLOGICAL	rF1V vaccine 160 mcg given on Study Days 0, 56, 182	rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-02-01
• Completion: 2008-10-01
• First posted: 2006-06-02
• Last updated: 2011-12-02

Locations

9 sites across 1 country: United States