Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098098
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2004-12-03
Brief Title:
Study to Evaluate the Safety Tolerability and Immunogenicity of Recombinant Botulinum Vaccine AB in Healthy Adults
Sponsor:
DynPort Vaccine Company LLC A GDIT Company
Organization:
DynPort Vaccine Company LLC A GDIT Company
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Escalating Study to Evaluate the Safety Tolerability and Immunogenicity of Recombinant Botulinum Vaccine AB in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AB 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 AB 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 05 mL intramuscular im 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None