Efficacy of GM-CSF as an Adjuvant to Hepatitis B Vaccination in Patients with Chronic Renal Failure—Results of a Prospective, Randomized Trial

Figures & data

Figure 1. Schematic representation of the study protocol.

Table 1. Demographic and biochemical profile of the study groups.^a

Parameters (mean±SD)	Group I	Group II
Mean age (years)	45.8 ± 15	45.6 ± 11
M:F ratio	19/12	21/12
Haemoglobin (g/dL)	8.7 ± 1.9	9.1 ± 2.4
TLC (per mm^3)	7561 ± 1676	7525 ± 2308
Urea (mg/dL)	114.3 ± 40.9	129.3 ± 45
Creatinine (mg/dL)	4.99 ± 1.8	4.96 ± 1.9
CCR (mL/min)	17.8 ± 12.2	18.76 ± 11.5
Etiology of CRF (n)
– Diabetes	8	9
– HT	6	6
– CGN	4	6
– CIN	4	3
– Obstructive uropathy	3	4
– ADPKD	2	1
– Other	4	4

Data of the 63 patients available at 3 months.

TLC: total leucocyte count; HT: hypertension; CGN: chronic glomerulonephritis; CIN: chronic interstitial nephritis; ADPKD: autosomal dominant polycystic kidney disease.

Table 2. Response rates to hepatitis B vaccination in the two groups at 3 and 7 months

Time	Group	No. of patients	No. of responders	Response rate (%)	Antibody titers (mean ± SD)
3 Months	I	31	19	61.3	127.4 ± 163.3
	I-HD	13	7	53.8	86.1 ± 139.4
	I-ND	18	12	66.7	157.2 ± 176.4
	II	33	26	78.8 (NS)	198.8 ± 201.0 (NS)
	II-HD	13	9	69.2 (NS)	102.3 ± 132.8 (NS)
	II-ND	20	17	85.0 (NS)	264.7 ± 215.7 (NS)
7 Months	I	27	20	74.1	243.7 ± 234.1
	I-HD	11	7	63.6	166.4 ± 200.3
	I-ND	16	13	81.2	296.9 ± 247.5
	II	28	25	89.3 (NS)	409.6 ± 251.6 (p = 0.014)a
	II-HD	11	9	81.8 (NS)	273.6 ± 203.1 (NS)
	II-ND	17	16	94.1 (NS)	497.6 ± 245.1 (NS)

NS—non-significant on comparison with respective control groups.

^aWith respect to Group I.

Table 3. Response rates to hepatitis B vaccination in patients receiving 50, 100, or 150 µg GM-CSF

Time	Group	No. of patients	No. of responders	Response rate (%)	Antibody titers (mean ± SD)
3 Months	II-50	11	7	63.6 (NS)	160.0 ± 217.4 (NS)
	II-100	11	9	81.8 (NS)	204 ± 176.8 (NS)
	II-150	11	10	90.9 (NS)	232.7 ± 216.6 (NS)
7 Months	II-50	9	7	77.8 (NS)	344.4 ± 234.6 (NS)
	II-100	9	8	88.9 (NS)	414.4 ± 231.8 (NS)
	II-150	10	10	100 (NS)	464.6 ± 245.1 (p = 0.032)a

NS—non-significant on comparison with Group I.

^aWith respect to Group I.

Table 4. Response to hepatitis B vaccine in hemodialysis patients treated with GM-CSF as an adjuvant

Authors	Ref.	No. of patients who received GM-CSF	Dose of GM-CSF	No. of doses of hepatitis B vaccine	Response rate
					GM-CSF (%)	Control (%)
Hess et al. (1996)	[[21]]	6	0.5 µg/kg	1	16.6	—
		5	5 µg/kg	1	80.0	—
		4	10 µg/kg	1	50.0	—
Anandh et al. (1997)	[[22]]	4	200 µg/kg	3	75	16.7
Sudhagar et al. (1999)	[[23]]	8	150 µg	1	87.5	25
Malhotra et al. (1999)	[[24]]	15	150 µg	2	66.7	33.5
Kapoor et al. (1996)	[[16]]	6	150 µg	4	100	44
Anandh et al. (2000)	[[25]]	6	150–200 µg	1	83	33

Figure 2. Relationship between creatinine clearance and anti-HBs responses in patients treated conservatively (not dialyzed, ND) (2a) or with hemodialysis (HD) (2b). The antibody response curve is shifted to the right with the use of GM-CSF as a vaccine adjuvant. The data represent the antibody titers at 3 months.

Table 5. Comparison of mean antibody titers in study groups

		Mean antibody titers (IU/L)
Time period	Group	ND	HD	p Value
3 Months	I	157.2	86.2	0.221
	II	264.7	102.3	0.013
7 Months	I	296.9	166.4	0.144
	II	497.6	273.6	0.015

ND—non dialysis.

HD—hemodialysis.

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