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At least 199 records · Page 11Linked to original sources
PubMed1981

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.

Alanine Transaminase↗
PubMed1981

Long-term tolerance and recovery of beta-propiolactone/ultraviolet (beta PL/UV) treated PPSB in chimpanzees.

Recent experiments have shown that a preparation of PPSB (factor IX concentrate) derived form beta PL/UV treated plasma was not infectious in chimpanzees with respect to hepatitis B and non-A, non-B. To answer the question whether the beta PL/UV treatment influences the tolerance and efficacy of the PPSB-concentrate, long-term application of PPSB-Biotest was carried out in chimpanzees. After 10 applications of 25 U factor IX/kg at weekly intervals, no signs of intolerance were observed by measurement of blood pressure during i.v. application and by means of skin-testing. Determination of coagulation factor activity during the application period revealed the same factor IX recovery at the beginning and at the end of the study.

Animals↗
PubMed1978

[Properties and potency of a rabies vaccine produced on the brain matter of young goats and inactivated by beta-propiolactone].

The vaccine produced by the Institut Pasteur of Algeria consists of a 5% suspension of brain matter of young goats inoculated with the Louis Pasteur Saïgon strain. The suspension is BPL-inactivated, supplemented with a protective agent and lyophilized to a volume of 2 ml. The vaccine loses all specific and non-specific toxicity when injected into newborn mice, adult mice and rabbits. The stability of this vaccine, studied over a period of 24 months at room temperature and 6 months at 37 degrees C, is very satisfactory. The average protective capacity for some twenty batches is 1.60 as determined by the NIH test and 700,000 protective units according to the Habel test. The immunogenicity of this vaccine is evaluated by measuring the neutralizing antibodies in individuals who have been vaccinated for preventive purposes as well as in individuals who have been treated after a possibly contaminating contact. The possibility of reducing the number of injections to 7 + 3 boosters rather than 14 + 2 boosters is discussed in the light of the results obtained.

Algeria↗