Related Experiment Videos
A clinical study of the tolerance and safety of a beta-propiolactone-treated immunoglobulin
In an open clinical study, 31 healthy volunteers were each given three i.v. infusions of 50 ml of a immunoglobulin preparation (Intraglobin) from three different production batches. During a 35-week observation period every three weeks blood specimens were drawn from the participants and analysed for serological (HBsAg, anti-HBs, anti-HBc, HBeAg and anti-HBe) and clinico-chemical parameters of hepatitis (SGOT, SGPT, gamma-GT and bilirubin levels). In no case evidence of the development of hepatitis arose, nor did the participants suffer from any side-effects during or after the infusions. Ten out of the 31 subjects then received another 150 ml infusion followed by an intradermal application of the new immunoglobulin in a 1:10 dilution four weeks later. No signs of immediate or delayed hypersensitivity reactions could be observed in the volunteers.
In an open clinical study, 31 healthy volunteers were each given three i.v. infusions of 50 ml of a immunoglobulin preparation (Intraglobin) from three different production batches. During a 35-week observation period every three weeks blood specimens were drawn from the participants and analysed for serological (HBsAg, anti-HBs, anti-HBc, HBeAg and anti-HBe) and clinico-chemical parameters of hepatitis (SGOT, SGPT, gamma-GT and bilirubin levels). In no case evidence of the development of hepatitis arose, nor did the participants suffer from any side-effects during or after the infusions. Ten out of the 31 subjects then received another 150 ml infusion followed by an intradermal application of the new immunoglobulin in a 1:10 dilution four weeks later. No signs of immediate or delayed hypersensitivity reactions could be observed in the volunteers.