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Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B

NCT00764634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2011-12-02

No results posted yet for this study

Summary

This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.

Conditions

  • Botulism Vaccine

Interventions

BIOLOGICAL

Placebo (USP sterile saline for injection)

0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182

BIOLOGICAL

rBV A/B-40 vaccine

0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182

BIOLOGICAL

Placebo (USP sterile saline for injection)

0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182

BIOLOGICAL

rBV A/B-40 vaccine

0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182

Sponsors & Collaborators

  • DynPort Vaccine Company LLC, A GDIT Company

    lead INDUSTRY

Principal Investigators

  • William Swiderski · DynPort Vaccine Company LLC

  • George A. Saviolakis, M.D. · DynPort Vaccine Company LLC

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-03-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00764634 on ClinicalTrials.gov