This study will evaluate the immune response to rabies vaccination persons 18 years and older. We will evaluate thirty healthy participants across three cohorts: 1) standard rabies pre-exposure prophylaxis regimen (two doses of Imovax® or RabAvert® seven days apart with no RIG); 2) rabies pre-exposure prophylaxis regimen + day 0 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 0); 3) rabies pre-exposure prophylaxis regimen + day 28 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 28).
This study will evaluate the immune response to rabies vaccination persons 18 years and older. We will evaluate thirty healthy participants across three cohorts: 1) standard rabies pre-exposure prophylaxis regimen (two doses of Imovax® or RabAvert® seven days apart with no RIG); 2) rabies pre-exposure prophylaxis regimen + day 0 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 0); 3) rabies pre-exposure prophylaxis regimen + day 28 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 28). RANDOMIZATION PROCEDURES Participants will be randomized 1:1 to either: Arm-1 Imovax or RabAvert- 2 doses 7 days apart or Arm-2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0 Once 20 participants are enrolled to arms 1 and 2 10 more participants will be enrolled to: Arm-3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28 We plan to enroll 30 evaluable participants in the coming year, anticipating up to 30 enrolling in the optional FNA and BMA assessments
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Washington University School of Medicine Infectious Disease Clinical Trials Unit.
St Louis, Missouri, United States
Comparison of antibody titers at D28 versus baseline
Comparison of antibody titers at D28 versus baseline
Time frame: 28 days
Comparison of antibody titers at D365 versus baseline
Comparison of antibody titers at D365 versus baseline
Time frame: 365 days
Frequency serious adverse events
Number of serious adverse events reported
Time frame: time of consent to day 365
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