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. 2016 Aug 31;12(12):3079–3088. doi: 10.1080/21645515.2016.1221872

Table 2.

Study schedule of events.

  SCREENING VACCINATION
 FOLLOW-UP
PHASE Screening Visit 1 1st Vacc Visit 2 Visit 3 Visit 4 2nd Vacc Visit 5 Visit 6 Visit 7 3rd Vacc Visit 8 Visit 9 Visit 10
VISITPROCEDURES Day - 28 ±3 days Day 0 ±3 days Day 1 ±3 days Day 2 ±3 days Day 21 ±3 days Day 22 ±3 days Day 23 ±3 days Day 42 ±3 days Day 43 ±3 days Day 44 ±3 days Day 63/(ET)±3 days
Pre-selection and informed consent √                    
Saline injection to test for urticaria √                    
Demographics and medical history(incl. current medications) √                    
Drug history (incl. alcohol) √                    
Physical examination √                   √
Clinical laboratory tests1 √ √     √     √     √
HLA-typing2   √                  
β-HCG 7 Serum-S/Urine -U √ (S) √ (U)     √ (U)     √ (U)      
Virology3 √                   √ (HSV only)
Height and weight4 √ √     √     √     √
Inclusion/Exclusion criteria √ √5                  
Check-in   √     √     √     √
Vital signs6 √ √     √     √     √
Alcohol and drug screen √ √     √     √      
Study vaccine administration and bleb checked   √     √     √      
Issue and collect diary cards   √ √ √ √ √ √ √ √ √ √
Review diary cards     √ √ √ √ √ √ √ √ √
Injection site examination8 √ (for suitability) √ √ √ √ √ √ √ √ √ √
Adverse events and concomitant medications9   √ √ √ √ √ √ √ √ √ √
HSV Serology10   √     √     √     √
ELISPOT11   √     √     √     √
Check-out12   √     √     √     √

ET = Early Termination;

1)

Samples for biochemistry and haematology panel collected at Screening, before each vaccination and on Day 63/ET (Visit 10).

2)

Human Leukocyte Antigen (HLA) typing sample collected before vaccination on Day 0 (Visit 1) only.

3)

Hepatitis B surface antigen (Hep B sAg), Hepatitis C (Hep C) and HIV, HSV 1 and HSV 2 serology. The Screening tests for HSV 1 and 2 could be conducted up to 60 days before the first vaccination.

4)

Height and weight for Body Mass Index (BMI) at Screening. Weight check only performed at each clinical laboratory test visit to calculate creatinine clearance.

5)

Exclusion criteria checked since previous visit before vaccination.

6)

Blood pressure, radial heart rate, aural temperature and respiratory rate measured at Screening, before and 30 minutes after each vaccination and on Day 63/ET (Visit 10).

7)

Urine β-Human chorionic gonadotropin (HCG) was negative before each vaccination.

8)

Injection site examined, marked and photograph taken prior to each vaccination, 45 minutes, one day and 2 days after each vaccination and on Day 63/ET (Visit 10).

9)

Adverse events and concomitant medications were recorded at check-in, at end of study evaluation and at any other time when spontaneously reported by a subject.

10)

HSV Serology included HSV anti-gD2 antibodies by ELISA and anti-gD2 neutralising titres by PRNT50 collected 60 minutes prior to each vaccination and on Day 63/ET (Visit 10).

11)

Blood sample for IFN-γ ELISPOT collected before 60 minutes prior to each vaccination and on Day 63/ET (Visit 10).

12)

Checkout following completion of the visit assessments.