Bone marrow suppression and anemia are frequent side effects of treatment of the acquired immunodeficiency syndrome (AIDS) with zidovudine (formerly azidothymidine [AZT]). We conducted a randomized, double-blind, placebo-controlled clinical trial of recombinant human erythropoietin (100 U per kilogram of body weight thrice weekly by intravenous bolus) in 63 patients with AIDS treated with zidovudine (29 in the erythropoietin group and 34 in the placebo group). Reductions in the number of units of red cells transfused and the number of patients given transfusions per month became apparent in the second and third months of the trial. The reductions were observed in patients with endogenous erythropoietin levels less than or equal to 500 IU per liter at base line, but not in patients whose levels were greater than 500 IU per liter at the beginning of the study. Although the hematocrit and hemoglobin level were not used as the primary criteria of efficacy because the patients received transfusions when their physicians decided that they needed them, a significantly higher rate of increase in the hematocrit was observed in the patients treated with recombinant human erythropoietin whose levels of endogenous erythropoietin were less than or equal to 500 IU per liter (0.00353 points per week) than in the patients given placebo (0.00116 points per week). This effect was not seen in patients with higher levels of endogenous erythropoietin. Serious side effects did not occur more often in the group treated with erythropoietin than in the placebo group. We conclude that recombinant human erythropoietin may be useful in patients with AIDS treated with zidovudine, although the indicators for its use remain to be clarified.

Therapy with r-HuEPO can increase the mean hematocrit and decrease the mean transfusion requirement in anemic patients with AIDS who are receiving zidovudine and have endogenous low erythropoietin levels (< or equal to 500 IU/L). Such therapy is of no apparent benefit in patients whose endogenous erythropoietin levels are higher than 500 IU/L.

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In November 2001, United States citizens became acutely aware of the potential for bioterrorism within our borders. With the introduction of anthrax bacilli (Bacillus anthracis) into the U.S. Postal Service system, the threat of other forms of bioterrorism became a reality. Biological terrorism, or bioterrorism, involves the use or the threat of using diseasespreading microorganisms and/or toxins as weapons of mass destruction. The use of B. anthracis as a weapon of terrorism has resulted in a heightened review of other potential bioterrorism agents. Smallpox virus (variola virus) is considered to pose the greatest risk.In 1980 the World Health Organization Smallpox Eradication Program declared that the disease, and the need for a vaccine with possible adverse reactions, had been eliminated (1-3). However, stocks of variola virus were "officially" maintained in the United States and in the Soviet Union for experimental purposes (6). The dissolution of the Soviet Union led to concerns regarding safety control of a number of State properties, including stocks of variola virus. Other unknown illicit smallpox virus sources may exist, and these may serve as a potential for bioterrorism threats.Most adults 35 years old and older were vaccinated for smallpox at least once prior to entering school. An unknown parameter of this smallpox vaccination, however, is the duration of its protection, as determined by the presence of antibody. It is generally accepted that the original vaccination would be protective for about 5 to 10 years, although the World Health Organization Committee on International Quarantine suggested that international travelers be vaccinated within the 3 years prior to travel (5). Multiple vaccinations provide long-term protection (4); however, the duration of antibody from the single original smallpox vaccination has not been recently evaluated. Do adults who received a single vaccination as a child still have any residual antibody? Many individuals are concerned with regard to protection against smallpox infection and specifically with whether they themselves have antibodies. Each serum donor was questioned regarding the number of times he or she was vaccinated.In this study, the presence of humoral antibody in vaccinated and unvaccinated (control) individuals was investigated. Those who had received additional booster vaccinations were noted, and their results were reported separately from those for individuals who had received a single vaccination. As it is not known whether antibody detected by enzyme immunoassay (EIA) is protective, it was of interest to determine if another antibody test would yield similar results. Accordingly, for comparison, 60 of the EIA-tested sera were also examined by serum neutralization (SN). MATERIALS AND METHODSTwo hundred four sera from adults of various ages, but at least 35 years of age, were submitted to the ESOTERIX Infectious Disease Center laboratory by their physicians for the detection of vaccinia virus antibody. All claimed to have been vaccinated as childre...

A randomised, placebo-controlled, multi-centre trial of intracellular subunit herpes simplex virus (HSV) type 1 vaccine NFU.Ac.HSV-1(S-)MRC (Skinner vaccine) was conducted at three medical centres in the United States. Subjects with documented herpes genitalis of at least 1-year duration and a history of six or more genital HSV recurrences in the 12 months prior to study entry were randomised to receive vaccine or placebo at 0, 1 and 2 months. Vaccination induced significant neutralising, enzyme-linked immunosorbent assay and lymphocyte transformation response to HSV-1 antigen. The frequency of recurrences was reduced in the vaccinated female patients at both 3 and 6 months following vaccination with an overall reduction in patients of both sexes which did not reach statistical significance. Recurrence severity was reduced as measured by decreased number of lesions and associated symptoms per recurrence (P = 0.04). The data suggest that clinical manifestations of latent HSV genital infection may be modified by therapeutic immunisation.