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Virus Therapy
Vaccination for Tularemia
Phase 2
Waitlist Available
Led By Anthony Cardile, DO
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test if a new vaccine for Francisella tularensis, the bacteria which causes tularemia, is safe and effective.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.
Number for adverse events.
Number of erythematous papule, vesicle, and/or eschar with or without underlying induration
Secondary outcome measures
Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual
Side effects data
From 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
Trial Design
1Treatment groups
Experimental Treatment
Group I: VaccinationExperimental Treatment1 Intervention
Live Francisella Tularensis Vaccine
Find a Location
Who is running the clinical trial?
U.S. Army Medical Research and Development CommandLead Sponsor
286 Previous Clinical Trials
244,759 Total Patients Enrolled
2 Trials studying Tularemia
484 Patients Enrolled for Tularemia
Anthony Cardile, DOPrincipal InvestigatorUSAMRIID Medical Division
2 Previous Clinical Trials
1,000 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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