Safety follow-up visits were at 7 days to 10 days, 28 4 days, and 56 4 days after receiving vaccination. RESULTS Study Population Thirty-two individuals completed the protocol and were included in the final results. 127 amino acids characterized by 3 primary molecular species, which have molecular masses of 19,500 days, 16,800 days, and 15,500 days. The amino-acid sequence of recombinant product differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein. The biologic potency, as tested against the World Health Organization First International Reference Standard, is approximately 5.6 106 IU/mg, and the dose used in this study was 250 g. Vaccine Response Response to PPV was determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of using methods previously described Ionomycin calcium from this laboratory5; the results are reported in g/mL. An individual was regarded as having responded if there was a 2-fold rise in anticapsular IgG when the prevaccination titer was compared with levels either 4 weeks or 12 weeks postvaccination (whichever was higher) and with a final level >0.5 g/mL. Geometric mean titers for each vaccine-dose group were calculated, and statistical comparisons were made using the Student test. The rationale for the sample size was as follows: A sample size of 16 patients would have achieved 94% power to detect a difference of 50 between the null hypothesis mean of 250 and the alternative hypothesis mean of 200 with an estimated standard deviation of 60 and a 1-sided significance level of 5%. Therefore, 16 patients should have been sufficient to Ionomycin calcium detect an inefficacious immune response. Adverse Events A diary card was provided to patients for self-documentation of adverse reactions that hSPRY2 included soreness, tenderness, erythema, or swelling at the vaccination site; malaise, myalgia, feeling feverish, and actual fever were also recorded. Safety follow-up visits were at 7 days to 10 days, 28 4 days, and 56 4 days after receiving vaccination. RESULTS Study Population Thirty-two individuals completed Ionomycin calcium the protocol and were included in the final results. The patients and disease characteristics are shown in Table 1. Among 4 patients with hypogammaglobulinemia, IgG levels were 325 mg/dL, 265 mg/dL, 160 mg/dL, and 110 mg/dL. Rai-Sawitsky stages were comparable among the study groups: Of the patients who received GM-CSF before vaccination, 46% (n = 6) were in complete clinical remission (CR), and 54% (n = 7) had stable disease. Among the patients who received GM-CSF after vaccination, 58% (n = 7) were in CR, and 42% (n = 5) had stable disease. Among 7 patients who received vaccine alone, most patients (71% n = 5) had cancer in CR. TABLE 1 Patient and Underlying Disease Characteristics >.05 for all comparisons; Student test). A 2-fold increase in geometric mean IgG levels was observed for only 1 1 capsular polysaccharide in each group, and the overall rises in titers were remarkably similar and equally low (differences were not significant for all comparisons; >.05). Vaccine-related Adverse Events All patients were followed for 6 months after vaccination, and no serious vaccine-related adverse reactions were noted. Among patients who received GM-CSF before vaccination, 1 patient each had pain and redness at the cytokine injection site, palmer erythema, and a low-grade fever (38 C) for 1 day. Whereas, in patients who received GM-CSF after PPV, 5 patients had pain and redness at the injection site, and 1 patient developed self-limiting cold-like symptoms. In patients who received PPV alone, 1 Ionomycin calcium patient developed pain and redness at the injection site. DISCUSSION In this Ionomycin calcium randomized study of patients with CLL, multiple-dose GM-CSF given before or after PPV was not associated with enhanced serum antibody responses.