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Biomedical subjects

J B McClain

Publications and source records attributed to J B McClain.

14 recordsLinked to original sources
PubMed2001

Unusual persistence in healthy volunteers and ill patients of hyperimmune immunoglobulin directed against multiple Pseudomonas O-chain and Klebsiella serotypes after intravenous infusion.

Persistence of intravenous (i.v.) hyperimmune immunoglobulin (100 mg/kg) directed against clinically predominant serotypes of Pseudomonas and Klebsiella in ill, febrile patients was compared to healthy volunteers to determine if ill patients have a decreased Ig half-life resulting in an increased immunoglobulin requirement. Type-specific antibodies were measured by ELISA for 83 days in eight healthy volunteers and for 35 days in eight ill patients with surgical complications or hematologic malignancy. Mean values and fold rises of antibody concentrations for the two groups were above preinfusion values at 35 days. The antibody fold rises in patients and in healthy volunteers were similar. Type-specific antibody levels in some patients increased after illness coincident with elevation of total immunoglobulins. We conclude that the duration of potentially therapeutic levels of infused type-specific hyperimmune immunoglobulin may persist for a longer period of time than what has been measured for total immunoglobulin. While the mechanism of this persistence remains to be characterized, the possibility of type-specific antibody synthesis induced by immunoglobulin administration must be considered.

Adult↗
PubMed2001

Experimental gonococcal urethritis and reinfection with homologous gonococci in male volunteers.

BACKGROUND: Reinfection, a common occurrence with gonorrhea, may result from a lack of protective immune response, or from the tremendous gonococcal strain variation. GOAL: A two-phase study in human volunteers tested whether experimental infection with Neisseria gonorrhoeae MS11mkC would protect against reinfection with the same organisms. STUDY DESIGN: In phase 1, an intraurethral inoculum of 57,000 piliated, transparent (opacity protein-negative [Opa-]) MS11mkC N gonorrhoeae infected 14 of 15 (93%) volunteers. The volunteers were encouraged to delay treatment for at least 5 days. In phase 2, which began 2 weeks after treatment for the initial infection, volunteers were inoculated with 7,100 piliated, Opa- MS11mkC. RESULTS: The phase 2 challenge infected 6 of 14 (43%) previously infected volunteers and 5 of 10 (50%) naïve control subjects. Phase 1 volunteers who resisted reinfection were significantly more likely to have had a fourfold or greater increase in lipooligosaccharide immunoglobulin G during phase 1 than those who did not resist reinfection (P = 0.026). CONCLUSIONS: Although infection did not provide protection from reinfection under the conditions used, the results suggest that immunity to reinfection is more complex than anticipated by the experimental design.

Adolescent↗
PubMed1998

A phase II study of BTI-322, a monoclonal anti-CD2 antibody, for treatment of steroid-resistant acute graft-versus-host disease.

BTI-322, a rat monoclonal IgG2b directed against the CD2 antigen on T cells and natural killer (NK) cells, blocks primary and memory alloantigen proliferative responses in vitro. We have evaluated the pharmacokinetics and safety of BTI-322 during treatment of 20 transplant recipients with steroid-refractory acute graft-versus-host disease (GVHD). Treatment consisted of BTI-322 by intravenous (IV) bolus or 30-minute infusion at approximately 0.1 mg/kg/d for 10 days in addition to continuing high-dose steroids and tacrolimus or cyclosporine. Pharmacokinetic sampling was performed in 10 patients; the t1/2 +/- SE was 9.1 +/- 1.3 hours, the Cmax was 2,549 +/- 291 ng/mL, the Vd was 3.97 +/- 0.95 L, and the Vd/kg was 0. 05 +/- 0.01 L/kg. Ten patients experienced transient dyspnea sometimes accompanied by nausea, vomiting, diarrhea, and tachycardia shortly after the initial bolus dose of drug, but serious drug-related adverse events were not seen during the remainder of the infusions. At the end of treatment (day 11), there were six patients with complete responses and five with a reduction in grade of GVHD for a total response rate of 55% (95% confidence interval [CI], 32% to 77%). Antibodies targeting CD2 may be active in the treatment of acute GVHD, and evaluation of a humanized form of BTI-322 is warranted.

Adult↗
PubMed1998

Laboratory evaluation of a dot-blot enzyme immunoassay for serologic confirmation of illness due to Rickettsia conorii.

Of the 169 United States Army soldiers who deployed on a field training exercise to a remote area of Botswana for two weeks in January 1992, more than 30% developed a febrile illness within five days of their return. A diagnosis of South African tick typhus was suggested by soldiers' exposure to ticks, as well as the presence of eschars and vesicles at the site of tick bites, and tender regional lymphadenopathies. This high attack rate, experienced during such a short exposure period, emphasizes the hazard of illness due to Rickettsia conorii to persons visiting endemic areas. A rapid, diagnostic, semiquantitative enzyme immunoassay (DS) for detection of IgG and IgM antibodies to R. conorii was performed on 209 acute and convalescent sera from soldiers in the outbreak and on 75 control sera. For the acute sera from soldiers meeting the probable case definition of having both regional lymphadenopathy and tick bite eschar, as judged by an IgG indirect fluorescent antibody (IFA) test, the resulting sensitivity and specificity of the DS test were 100% and 48%, respectively. In the analysis of the acute sera, the DS test identified as reactive more of the probable cases (62%) than either the IgG (16%) or IgM (55%) IFAs. This simple and rapid diagnostic test could be useful in establishing a preliminary diagnosis of R. conorii rickettsiosis in remote settings when immediate confirmation by IFA is impossible.

Antibodies, Bacterial↗
PubMed1994

Phase 1 trial of a 24-valent Klebsiella capsular polysaccharide vaccine and an eight-valent Pseudomonas O-polysaccharide conjugate vaccine administered simultaneously.

A Klebsiella (K) vaccine consisting of 24 capsular polysaccharide antigens and a Pseudomonas aeruginosa (P) vaccine consisting of eight O-polysaccharide antigens conjugated to P toxin A have been developed to prevent sepsis by means of active or passive immunoprophylaxis. In search for a practical immunization schedule, the two vaccines were injected in opposite arms simultaneously (20 volunteers) or 14 days apart (21 volunteers). The vaccines were similarly well tolerated by both volunteer groups. Geometric mean antibody concentrations and mean fold antibody rises to the 33 vaccine antigens (including toxin A) were similar in the two groups at 2 months, and the decline in antibody measured at 18 months was also similar. Because the two vaccines were safe and similarly immunogenic in the two vaccine groups, they can be administered simultaneously to patients or plasma donors in a practical vaccination schedule.

Adolescent↗
PubMed1989

Oral ciprofloxacin and a monoclonal antibody to lipopolysaccharide protect leukopenic rats from lethal infection with Pseudomonas aeruginosa.

To study the treatment of infection with Pseudomonas aeruginosa, a leukopenic rat model was developed that closely mimics the pathogenesis of Pseudomonas infection in man. This model achieved approximately 90% mortality within 10 d of infection. Pseudomonas organisms were inconsistently shed from the feces despite gastrointestinal colonization (9 fecal v. 23 cecal cultures positive for challenge strain in 28 rats). Treatment of rats with oral ciprofloxacin at 40 mg/kg afforded complete protection. A suboptimal dose of ciprofloxacin (20 mg/kg), achieving peak levels of 0.31 micrograms/mL in serum and 26.3 micrograms/mL in stool, resulted in survival of 8 (40%) of 20 rats. Intraperitoneal administration of a monoclonal antibody directed at the lipopolysaccharide of the challenge strain of Pseudomonas resulted in survival of 5 rats (26%). The combination of the two increased the survival to 75% (15 of 20, P less than 0.05 compared to either treatment alone). Thus, the combination of suboptimal doses of ciprofloxacin and a monoclonal antibody appears to protect leukopenic rats from lethal infection better than either treatment alone.

Administration, Oral↗
PubMed1988

Chloramphenicol, gentamicin, and ciprofloxacin against murine scrub typhus.

Ciprofloxacin (120 mg/kg of body weight per day), chloramphenicol (300 mg/kg per day), and gentamicin (30 mg/kg per day) were compared with placebo in a BALB/cj mouse model of scrub typhus. All animals treated with ciprofloxacin and chloramphenicol survived. All animals treated with gentamicin or placebo died. All surviving animals showed evidence of seroconversion. Ciprofloxacin and chloramphenicol were statistically more effective in preventing death than gentamicin or placebo.

Animals↗
PubMed1987

Safety and efficacy of high-dose sodium stibogluconate therapy of American cutaneous leishmaniasis.

40 patients with American cutaneous leishmaniasis caused primarily by Leishmania braziliensis panamensis were treated with sodium stibogluconate in a double-blind, randomised controlled trial. Nine weeks after starting treatment, all 19 patients treated with 20 mg Sb/kg per day for twenty days were cured but 5 of 21 patients treated with 10 mg Sb/kg per day for twenty days had persistent active disease (p less than 0.05). Both treatment regimens were well tolerated and they were associated with a similar incidence of reversible toxic effects. Existing recommendations for therapy of American cutaneous leishmaniasis with sodium stibogluconate are inadequate for some patients, and higher doses are both safe and efficacious.

Adolescent↗
PubMed1984

Doxycycline therapy for leptospirosis.

To study antibiotic efficacy, 29 patients with leptospirosis were treated in a randomized, double-blinded fashion with doxycycline, 100 mg orally twice a day, or placebo. Therapy was given for 7 days in a hospital, and patients were followed for 3 weeks afterwards. Duration of illness before therapy and severity of illness were the same in both groups. Doxycycline reduced the duration of illness by 2 days and favorably affected fever, malaise, headache, and myalgias. Treatment prevented leptospiruria and had no adverse effects. Doxycycline is effective in therapy for patients with leptospirosis.

Double-Blind Method↗