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Clinical and Experimental Immunology logoLink to Clinical and Experimental Immunology
. 1995 Jan;99(1):10–15. doi: 10.1111/j.1365-2249.1995.tb03465.x

A prospective controlled crossover trial of a new heat-treated intravenous immunoglobulin.

S R Zuhrie 1, A D Webster 1, R Davies 1, A C Fay 1, T B Wallington 1
PMCID: PMC1534151  PMID: 7813100

Abstract

Twenty-one patients with primary immunoglobulin deficiency were enrolled in a crossover study to test the efficacy and safety of Alphaglobin in comparison with the licensed preparations Sandoglobulin and Gamimune. There was no statistical difference in these parameters between Alphaglobin and Sandoglobulin/Gamimune. The level of total serum IgG and specific IgG to pneumococcal polysaccharides was similar in individual patients when they were receiving Alphaglobin or one of the other products. Transient increases in serum alanine transferase occurred in five patients on Sandoglobulin/Gamimune and two patients on Alphaglobin. Some patients showed a rise in total serum IgM afterwards, indicating a response to infection. However, serum hepatitis C virus (HCV) RNA was not found during the alanine transferase (ALT) rises, and IgM antibody to hepatitis A virus (HAV) was negative afterwards. We conclude that Alphaglobin is a safe, well tolerated and clinically efficacious treatment for patients with primary antibody deficiency.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Björkander J., Cunningham-Rundles C., Lundin P., Olsson R., Söderström R., Hanson L. A. Intravenous immunoglobulin prophylaxis causing liver damage in 16 of 77 patients with hypogammaglobulinemia or IgG subclass deficiency. Am J Med. 1988 Jan;84(1):107–111. doi: 10.1016/0002-9343(88)90016-2. [DOI] [PubMed] [Google Scholar]
  2. Garbett N. D., Currie D. C., Cole P. J. Comparison of the clinical efficacy and safety of an intramuscular and an intravenous immunoglobulin preparation for replacement therapy in idiopathic adult onset panhypogammaglobulinaemia. Clin Exp Immunol. 1989 Apr;76(1):1–7. [PMC free article] [PubMed] [Google Scholar]
  3. Garson J. A., Ring C. J., Tuke P. W. Improvement of HCV genome detection with "short" PCR products. Lancet. 1991 Dec 7;338(8780):1466–1467. doi: 10.1016/0140-6736(91)92775-w. [DOI] [PubMed] [Google Scholar]
  4. Hamamoto Y., Harada S., Yamamoto N., Uemura Y., Goto T., Suyama T. Elimination of viruses (human immunodeficiency, hepatitis B, vesicular stomatitis and Sindbis viruses) from an intravenous immunoglobulin preparation. Vox Sang. 1987;53(2):65–69. doi: 10.1111/j.1423-0410.1987.tb04919.x. [DOI] [PubMed] [Google Scholar]
  5. Horowitz B. Blood protein derivative viral safety: observations and analysis. Yale J Biol Med. 1990 Sep-Oct;63(5):361–369. [PMC free article] [PubMed] [Google Scholar]
  6. John T. J., Ninan G. T., Rajagopalan M. S., John F., Flewett T. H., Francis D. P., Zuckerman A. J. Epidemic hepatitis B caused by commercial human immunoglobulin. Lancet. 1979 May 19;1(8125):1074–1074. doi: 10.1016/s0140-6736(79)92964-7. [DOI] [PubMed] [Google Scholar]
  7. Lever A. M., Webster A. D., Brown D., Thomas H. C. Non-A, non-B hepatitis occurring in agammaglobulinaemic patients after intravenous immunoglobulin. Lancet. 1984 Nov 10;2(8411):1062–1064. doi: 10.1016/s0140-6736(84)91506-x. [DOI] [PubMed] [Google Scholar]
  8. Makris M., Preston F. E., Triger D. R., Underwood J. C., Choo Q. L., Kuo G., Houghton M. Hepatitis C antibody and chronic liver disease in haemophilia. Lancet. 1990 May 12;335(8698):1117–1119. doi: 10.1016/0140-6736(90)91124-s. [DOI] [PubMed] [Google Scholar]
  9. Matsumoto S., Kobayashi N., Gohya N. Clinical trials of sulfonated immunoglobulin preparation for intravenous administration. II. Adverse reactions. Eur J Pediatr. 1981 May;136(2):167–171. doi: 10.1007/BF00441919. [DOI] [PubMed] [Google Scholar]
  10. Non-A, non-B hepatitis and intravenous immunoglobulin. Lancet. 1985 Feb 16;1(8425):404–405. [PubMed] [Google Scholar]
  11. Nowak T., Gregersen J. P., Klockmann U., Cummins L. B., Hilfenhaus J. Virus safety of human immunoglobulins: efficient inactivation of hepatitis C and other human pathogenic viruses by the manufacturing procedure. J Med Virol. 1992 Mar;36(3):209–216. doi: 10.1002/jmv.1890360311. [DOI] [PubMed] [Google Scholar]
  12. Prince A. M., Horowitz B., Horowitz M. S., Zang E. The development of virus-free labile blood derivatives--a review. Eur J Epidemiol. 1987 Jun;3(2):103–118. doi: 10.1007/BF00239746. [DOI] [PubMed] [Google Scholar]
  13. Stiehm E. R. Human gamma globulins as therapeutic agents. Adv Pediatr. 1988;35:1–72. [PubMed] [Google Scholar]
  14. Uemura Y., Uriyu K., Hirao Y., Takechi K., Ishikawa H., Nakajima T., Kagitani Y., Yokoyama K., Funakoshi S., Nishida M. Inactivation and elimination of viruses during the fractionation of an intravenous immunoglobulin preparation: liquid heat treatment and polyethylene glycol fractionation. Vox Sang. 1989;56(3):155–161. doi: 10.1111/j.1423-0410.1989.tb02019.x. [DOI] [PubMed] [Google Scholar]
  15. Williams P. E., Yap P. L., Gillon J., Crawford R. J., Urbaniak S. J., Galea G. Transmission of non-A, non-B hepatitis by pH4-treated intravenous immunoglobulin. Vox Sang. 1989;57(1):15–18. doi: 10.1111/j.1423-0410.1989.tb04977.x. [DOI] [PubMed] [Google Scholar]
  16. Yap P. L., McOmish F., Webster A. D., Hammarstrom L., Smith C. I., Bjorkander J., Ochs H. D., Fischer S. H., Quinti I., Simmonds P. Hepatitis C virus transmission by intravenous immunoglobulin. J Hepatol. 1994 Sep;21(3):455–460. doi: 10.1016/s0168-8278(05)80328-9. [DOI] [PubMed] [Google Scholar]

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