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.