The Food and Drug Administration (FDA) has developed grading scales for reactions to vaccines during clinical trials. One of these scales deals with changes in organ-related chemical tests.
Patient selection: renal reaction after the vaccination
Basic chemistry tests include:
(1) CPK in mg/dL or IU/L
(2) serum albumin g/dL
(3) total protein in g/dL
(4) serum alkaline phosphatase in IU/L
(5) serum ALT in IU/L
(6) serum AST in IU/L
(7) serum total bilirubin in mg/dL
(8) serum cholesterol in mg/dL
(9) serum amylase in IU/L
(10) serum lipase in IU/L
Serum BUN and creatinine are included in renal assessment.
Serum AST and ALT are considered liver function tests (LFTs).
Serum amylase and lipase are pancreatic enzymes.
Reduced urine output is not included as a measure.
|
Reaction |
Grade |
|
None |
0 |
|
Mild |
1 |
|
moderate |
2 |
|
severe |
3 |
|
potentially life threatening |
4 |
|
Renal Parameter |
Finding |
Grade |
|
CPK |
< 1.25 times ULN |
0 |
|
|
1.25 to 1.5 times ULN |
1 |
|
|
1.6 to 3.0 times ULN |
2 |
|
|
3.1 to 10 times ULN |
3 |
|
|
> 10 times ULN |
4 |
|
serum albumin |
> 3.1 g/dL |
0 |
|
|
2.8 to 3.1 g/dL |
1 |
|
|
2.5 to 2.7 g/dL |
2 |
|
|
< 2.5 g/dL |
3 |
|
serum total protein |
> 6.0 g/dL |
0 |
|
|
5.5 to 6.0 g/dL |
1 |
|
|
5.0 to 5.4 g/dL |
2 |
|
|
< 5.0 g/dL |
3 |
|
serum alkaline phosphatase |
<= 1 times ULN |
0 |
|
|
1.1 to 2.0 times ULN |
1 |
|
|
2.1 to 3.0 times ULN |
2 |
|
|
3.1 to 10 times ULN |
3 |
|
|
> 10 times ULN |
4 |
|
serum ALT |
<= 1.0 times ULN |
0 |
|
|
1.1 to 2.5 times ULN |
1 |
|
|
2.6 to 5.0 times ULN |
2 |
|
|
5.1 to 10 times ULN |
3 |
|
|
> 10 times ULN |
4 |
|
serum AST |
<= 1.0 times ULN |
0 |
|
|
1.1 to 2.5 times ULN |
1 |
|
|
2.6 to 5.0 times ULN |
2 |
|
|
5.1 to 10 times ULN |
3 |
|
|
> 10 times ULN |
4 |
|
serum total bilirubin with elevation in AST or ALT |
<= 1 times ULN |
0 |
|
|
1.1 to 1.25 times ULN |
1 |
|
|
1.26 to 1.5 times ULN |
2 |
|
|
1.51 to 1.75 times ULN |
3 |
|
|
> 1.75 ULN |
4 |
|
serum total bilirubin without elevation in AST or ALT |
<= 1 times ULN |
0 |
|
|
1.1 to 1.5 times ULN |
1 |
|
|
1.6 to 2.0 times ULN |
2 |
|
|
2.1 to 3.0 times ULN |
3 |
|
|
> 3 times ULN |
4 |
|
serum cholesterol |
<= 200 mg/dL |
0 |
|
|
201 to 210 mg/dL |
1 |
|
|
211 to 225 mg/dL |
2 |
|
|
>= 226 mg/dL |
3 |
|
serum amylase |
<= 1.0 times ULN |
0 |
|
|
1.1 to 1.5 times ULN |
1 |
|
|
1.6 to 2.0 times ULN |
2 |
|
|
2.1 to 5 times ULN |
3 |
|
|
> 5 times ULN |
4 |
|
serum lipase |
<= 1.0 times ULN |
0 |
|
|
1.1 to 1.5 times ULN |
1 |
|
|
1.6 to 2.0 times ULN |
2 |
|
|
2.1 to 5 times ULN |
3 |
|
|
> 5 times ULN=IF(B27 |
4 |
Specialty: Infectious Diseases, Pharmacology, clinical
