This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
Study Objectives: 1. To assess the safety of live F. tularensis vaccine NDBR 101. 2. To assess the immunogenicity of live F. tularensis vaccine NDBR 101.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
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.
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States
Number for adverse events.
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).
Time frame: 5 years
Number of erythematous papule, vesicle, and/or eschar with or without underlying induration
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.
Time frame: 7 (± 2 days) after vaccination
Microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.
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.
Time frame: 28-35 days
Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual
Documented occurrence of tularemia following exposure to F. tularensis in a successfully vaccinated individual (positive "take" reaction and seroconversion \[≥ 4-fold rise in antibody titer after vaccination\]).
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.