A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease. Recombinant Outer-Surface Protein A Lyme Disease Vaccine Study Consortium.

BACKGROUND: Lyme disease is a multisystem inflammatory disease caused by infection with the tick-borne spirochete Borrelia burgdorferi and is the most common vector-borne infection in the United States. We assessed the efficacy of a recombinant vaccine consisting of outer-surface protein A (OspA) without adjuvant in subjects at risk for Lyme disease. METHODS: For this double-blind trial, 10,305 subjects 18 years of age or older were recruited at 14 sites in areas of the United States where Lyme disease was endemic; the subjects were randomly assigned to receive either placebo (5149 subjects) or 30 microg of OspA vaccine (5156 subjects). The first two injections were administered 1 month apart, and 7515 subjects also received a booster dose at 12 months. The subjects were observed for two seasons during which the risk of transmission of Lyme disease was high. The primary end point was the number of new clinically and serologically confirmed cases of Lyme disease. RESULTS: The efficacy of the vaccine was 68 percent in the first year of the study in the entire population and 92 percent in the second year among the 3745 subjects who received the third injection. The vaccine was well tolerated. There was a higher incidence of mild, self-limited local and systemic reactions in the vaccine group, but only during the seven days after vaccination. There was no significant increase in the frequency of arthritis or neurologic events in vaccine recipients. CONCLUSIONS: In this study, OspA vaccine was safe and effective in the prevention of Lyme disease.

Pelvic cellulitis: a life-threatening complication of hemorrhoidal banding.

Rubber band ligation is a commonly employed office procedure for the eradication of symptomatic internal hemorrhoids. Since 1980 increasingly frequent reports of an often fatal complication--"pelvic cellulitis"--have appeared. Death has been avoided for some of these patients by early recognition and treatment. One such survivor is reported here, in a case report that illustrates the value of early recognition of symptoms and appropriate diagnostic and therapeutic intervention.

The diagnosis of invasive aspergillosis by an enzyme-linked immunosorbent assay for circulating antigen.

An inhibition enzyme-linked immunosorbent assay (ELISA) capable of detecting 10 ng of aspergillus carbohydrate antigen/ml of serum was developed. When retrospectively applied to the sera of 19 patients with invasive aspergillosis, the ELISA detected antigen in 11 patients. None of 14 healthy controls or 28 patients with a variety of other infections were positive for circulating antigen. A rabbit model of invasive aspergillosis was also developed. Daily fungal cultures of blood were negative in the rabbits, as in human disease, but antigen was detected in increasing amounts up to the time of death. This ELISA is a sensitive, specific, and easily performed assay for circulating aspergillus antigen that should facilitate early diagnosis of invasive aspergillosis, heretofore, seldom made without invasive tests.

Cryptococcal infection of the central nervous system.

The pathogenesis, clinical signs and symptoms, laboratory manifestations, and laboratory diagnosis of cryptococcal infection of the central nervous system are reviewed, as well as the interaction between the organism and the immune system of the host. In addition, based on our own experience and that of others, the therapy and prognosis of cryptococcal meningitis are discussed.