Morbidity and Mortality Weekly Report - November 13, 1987 / 36(44);728-9
Centers for Disease Control and Prevention

On September 18, 1987, the Armed Forces Medical Logistical Office issued instructions to temporarily suspend from distribution and use in military hospitals one lot (RHG 636) of RhoGAM* Rho(D) Immune Globulin (human) (Rh-IG), manufactured by Ortho Diagnostic Systems, Inc. This action was taken because a woman on active duty who had received an injection from the lot was subsequently found to be infected with human immunodeficiency virus (HIV). The woman received RhoGAM lot RHG 636 in September 1986, prior to the birth of her second child in December 1986. In addition, she had received an earlier injection of Rh-IG from a different lot in May 1985, prior to the birth of her first child.

The woman was first tested for HIV in November 1986 as part of the military screening program and was found to be seropositive for HIV antibodies at that time. At present, she remains seropositive with evidence of severe immunodeficiency but has not developed AIDS. Her first child, born in July 1985, was negative for HIV antibodies when tested in January 1987. Her second child tested positive for HIV antibodies at birth, but subsequent serologic testing performed at 9 months of age was negative, reflecting the loss of passively derived maternal antibody and the absence of infection.

An epidemiologic investigation determined that this woman very likely had a behavioral risk factor for infection with HIV. Samples of both Rh-IG lots from which the woman had received treatment have been studied by the U.S. Food and Drug Administration. They have been found to be free of anti-HIV antibodies. Lot RHG 636 was also tested and found to be free of HIV antigen. In addition, review of the manufacturer's records for RhoGAM lot RHG 636 confirmed that all plasma used for that lot had been screened for antibodies to HIV and found negative and that all steps in its manufacture were in accordance with good manufacturing practices. Reported by: Center for Drugs and Biologics, Food and Drug Administration. Office of the Surgeon General, US Army. AIDS Program, Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: Approximately 500,000 doses of Rh-IG are administered annually to an estimated 350,000 women in the United States. Rh-IG and other immune globulins used in the United States are produced by several manufacturers using one of the modifications of the Cohn-Oncley fractionation process (1,2), which has been shown to be effective in removing HIV by partitioning and inactivation (3). Since late April 1985, all units of plasma for production of Rh-IG have been screened for antibodies to HIV, and all repeatedly reactive units have been discarded. Several epidemiologic and laboratory studies have shown that recipients of hepatitis B immune globulin (HBIG) and immune globulin (IG), including recipients of lots manufactured before April 1985, have not developed either antibody responses indicative of HIV infection or clinical illness associated with HIV infection (4). Low levels of passively acquired HIV antibody from some preparations of HBIG that were known to contain high levels of HIV antibody have been reported, but this passively transferred HIV antibody has not persisted longer than 6 months (5).

Based on the history of the safety of IG products, the investigation of this case (which strongly suggests that the woman was exposed to HIV through other means), and the lack of evidence of HIV infection associated with Rh-IG despite receipt of these products by more than 350,000 women annually, there is no evidence to implicate this product as a source of HIV infection nor to change current recommendations for its use and administration. References

References

1. Cohn EJ, Strong LE, Hughes WL Jr, et al. Preparation and properties of serum and plasma proteins. IV: A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946;68:459-75.

2. Oncley JL, Melin M, Richert DA, Cameron JW, Gross PM Jr. The separation of the antibodies, isoagglutinins, prothrombin, plasminogen and beta1-lipoprotein into subfractions of human plasma. J Am Chem Soc 1949;71:541-50.

3. Wells MA, Wittek AE, Epstein JS, et al. Inactivation and partition of human T-cell lymphotrophic virus, type III, during ethanol fractionation of plasma. Transfusion 1986 Mar-Apr;26(2):210-3.

4. Centers for Disease Control. Safety of therapeutic immune globulin preparations with respect to transmission of human T-lymphotropic (sic) virus type III/lymphadenopathy-associated virus infection. MMWR 1986;35:231-3.

5. Tedder RS, Uttley A, Cheingsong-Popov R. Safety of immunoglobulin preparation containing anti-HTLV-III (Letter). Lancet 1985 Apr 6;1(8432):815. *Use of trade names is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services or the Public Health Service.

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