Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Longitudinal Phase 2 Study for the Continued Evaluation of the Safety and Immunogenicity of a Live Francisella Tularensis Vaccine, NDBR 101, Lot 4 in Healthy Adults At-Risk for Exposure to Francisella Tularensis|
- Number for adverse events. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]The nature (body system affected, type (local or systemic), severity, frequency of occurrence, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of adverse events for the assessment population (all subjects receiving one or more vaccinations under this protocol).
- Number of erythematous papule, vesicle, and/or eschar with or without underlying induration [ Time Frame: 7 (± 2 days) after vaccination ] [ Designated as safety issue: Yes ]Incidence of positive "take" reaction (development of an erythematous papule, vesicle, and/or eschar with or without underlying induration) following vaccination for all subjects regardless of compliance.
- Microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination. [ Time Frame: 28-35 days ] [ Designated as safety issue: No ]
Seroconversion will be evaluated for subjects who are compliant with the titer schedule.
Seroconversion is defined as microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.
- Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual [ Time Frame: 5 years ] [ Designated as safety issue: No ]Documented occurrence of tularemia following exposure to F. tularensis in a successfully vaccinated individual (positive "take" reaction and seroconversion [≥ 4-fold rise in antibody titer after vaccination]).
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Live Francisella Tularensis Vaccine
Biological: Live Francisella Tularensis Vaccine
Approximately 0.0025 mL of vaccine will be administered percutaneously with a bifurcated needle using 15 pricks on the volar surface of the forearm. Vaccination may be repeated up to two times within the year if successful vaccination is not demonstrated by a positive "take" reaction and a MA titer of ≥ 1:20.
Other Name: LVS Vaccine
- To assess the safety of live F. tularensis vaccine NDBR 101.
- To assess the immunogenicity of live F. tularensis vaccine NDBR 101.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787826
|United States, Maryland|
|U.S. Army Medical Research Institute of Infectious Diseases|
|Fort Detrick, Maryland, United States, 21702|
|Principal Investigator:||Anthony Cardile, DO||USAMRIID Medical Division|