Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
|ClinicalTrials.gov Identifier: NCT00787826|
Recruitment Status : Enrolling by invitation
First Posted : November 10, 2008
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tularemia||Biological: Live Francisella Tularensis Vaccine||Phase 2|
- To assess the safety of live F. tularensis vaccine NDBR 101.
- To assess the immunogenicity of live F. tularensis vaccine NDBR 101.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 28, 2009|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2019|
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
- Number for adverse events. [ Time Frame: 5 years ]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 ]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 ]
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 ]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]).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787826
|United States, Maryland|
|U.S. Army Medical Research Institute of Infectious Diseases|
|Fort Deterick, Maryland, United States, 21702|
|Principal Investigator:||Anthony Cardile, DO||USAMRIID Medical Division|