Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults

Phase 1

Completed

• Conditions: RECOMBINANT BOTULINUM VACCINE A/B

• Registration Number: NCT00098098
• Lead Sponsor: DynPort Vaccine Company LLC, A GDIT Company

Brief Summary

The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.

Detailed Description

The Phase 1 clinical trial is designed as a single-center, open-label, non-randomized study to evaluate the safety, tolerability and immunogenicity of a two-dose schedule of rBV A/B in healthy volunteers at three ascending dosage levels, 5 ug, 10 ug and 20 ug serotype-specific antigen (10 ug, 20 ug and 40 ug total immunizing protein) in three dosing cohorts and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level. Approximately 44 volunteers (11 per cohort) are expected to be enrolled. Cohorts will enroll consecutively beginning with the lowest dosage level. Volunteers in each cohort will receive a two injection series at the assigned dosage level given as a 0.5 mL intramuscular (i.m.) injection on Day 0 and Day 28. Potential volunteers for study participation will undergo qualification screening for this study during the 21 days prior to the date scheduled for vaccination. After successful completion of the informed consent process and all screening assessments, volunteers will be scheduled for vaccination. Volunteers will report acute adverse events daily for 28 days after each vaccination and return to the clinic at regular intervals according to the Schedule of Study Assessments with the last scheduled follow-up 168 days (± 7 days) after the initial vaccination (Day 0).

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-12-03
• Study First Submitted QC: 2004-12-03
• Study First Posted: 2004-12-06
• Study Completion: 2005-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of rBV A/B in healthy volunteers at three ascending dosage levels by cohort and a two-dose regimen of a formulation containing only antigens at the 40 ug dosage level.

Secondary Outcome Measures

Name	Time	Method
To evaluate the neutralizing antibody concentration of rBV A/B
Evaluate human toxin neutralizing antibody as a correlate of protective immunity.

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington,, Kentucky, United States