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Table 2 Study schema for study arms 1, 2 and 3

From: The role of pre-existing cross-reactive antibodies in determining the efficacy of vaccination in humans: study protocol for a randomized controlled trial

  Visit 1 screening (-21 to -1 days) Visit 2 - first vaccination (day 0) Visit 3 - second vaccination (+2 weeks from first vaccination)* Visit 4 - third vaccination (+2 weeks from second vaccination)*
   Pre-vaccination 1 hour post-vaccination Pre-vaccination 1 hour post-vaccination Pre-vaccination 1 hour post-vaccination
Inform consent ×       
Medical history and demographics ×       
Physical examination × x x x x   ×
Vital signsa × × × × × × ×
Hematology labsb ×       
Chemistry labs (liver, renal panelc) ×       
Dengue immunoglobulinGd ×       
Urine pregnancy teste × ×      
Adverse eventsf × ×   ×   ×  
Concomitant medications × ×   ×   ×  
Blood sampling in relation to YF17D vaccination       ×g  
  1. *Window period: for second vaccination is +2 weeks (vaccination cannot be done earlier); for third vaccination (group 1, 2, 3) is +2 weeks (vaccination cannot be done earlier). aVital signs include temperature (oral and tympanic allowed), blood pressure, pulse rate, and respiratory rate. bHematology labs include hemoglobin, red blood cell, white blood cell, hematocrit, platelet count, neutrophil, lymphocyte, monocyte, eosinophil, basophil. cLiver panel includes total protein, albumin, total bilirubin, alkaline phosphatase, ALT alanine transaminase, AST aspartate transaminase, gamma-glutamyl transpeptidase. Renal panel includes urea, sodium, potassium, chloride, bicarbonate, creatinine. dDengue immunoglobulin G will be tested by enzyme-linked immunosorbent assay. eFor females only. fClinical Trial Certificate Adverse Events version 4.0 will be used for grading. gFor third vaccination, pre-dose blood sample can be taken any time before dosing. YF, yellow fever.