The safety and immunogenicity of acellular pertussis (AP) vaccine in outbreak control was determined in a randomized, double-blind, controlled trial. Participants received AP vaccine (n=102), which contained 25 mug of pertussis toxoid (PT) and 3 mug of filamentous hemagglutinin (FHA), or licensed meningococcal vaccine (MN; n=97). Local reactions (pain or tenderness, redness, swelling, and induration) and systemic reactions (fever, sleepiness or lethargy, and irritability) were similar among AP and MN vaccinees. One month after AP vaccination, the geometric mean level of IgG anti-PT was 33.1 mug/mL, with 2-fold increases in 85% of patients and 4-fold increases in 73% of patients; for IgG anti-FHA, the respective values were 34.7 mug/mL, 92%, and 63%. After 6 months of follow-up, no serological evidence of pertussis was seen among symptomatic or asymptomatic subjects. However, recent evidence of Bordetella pertussis infection before immunization was shown. Thus, AP vaccine was safe and immunogenic in adults.
Therapy for patients with biliary atresia (BA) has become controversial, with orthotopic liver transplantation (OLTx) suggested in place of portoenterostomy. This is based on the unpredictable success of portoenterostomy, and the increased difficulty of the OLTx procedure following prior extensive liver surgery. The survival rate reported here for infants transplanted after unsuccessful portoenterostomy does not support this approach. OLTx was undertaken in 37 patients when end-stage liver failure followed primary portoenterostomy. Recipient age ranged from 6 months to 14 years (median, 13 months), and weight ranged from 5 to 45 kg (median, 8 kg) at the time of OLTx. Reduced-size allografts were used as the primary allograft in 25 patients (23 left lobe), and 12 received whole-organ allografts. Retransplantation was required in 5 patients, each received a reduced-size allograft. There was no increased incidence of vascular complications, primary nonfunction, irreversible rejection, intestinal perforation, biliary complications, sepsis, or lymphoma comparing the BA patients with all other non-BA patients who had undergone OLTx (all P = .16). There was no statistically significant difference in mean operative blood loss between BA patients (EBL = 1.99 BV) and non-BA patients (1.50 BV) (P = .14). Actuarial survival for the series of BA patients was 89% at 1 year, and 80% at 2 years. Following the introduction of reduced-size allografts, donor organs were selected for use with a priority on donor stability. The actuarial survival for BA patients during this time has improved to 96% at 1 year, and 91% at 2 years.(ABSTRACT TRUNCATED AT 250 WORDS)
The goal of any posttransplant immunosuppressive regimen is to prevent allograft rejection while minimizing infectious complications. We hypothesized that sequential induction immunotherapy using the monoclonal antibody ORTHOCLONE OKT3 (muromonab-CD3) would meet these objectives effectively. We have therefore used such a protocol since July 1988 for all pediatric patients undergoing liver transplantation at Children's Hospital Medical Center of Cincinnati. Initial immunotherapy consisted of OKT3, administered preoperatively and then QD, methylprednisolone, and azathioprine. Cyclosporine was begun on POD 3-5, and OKT3 was discontinued when therapeutic cyclosporine levels were achieved for 48 hours. Rejection has not occurred throughout the lifetime of the allograft in 55% of long-term survivors. In the 28 patients who experienced rejection episodes, 71% had a single episode, 21% had two episodes, and 7% had a single episode, 21% had two episodes, and 7% had more than two. Rejection occurring after more than 120 days was invariably associated with noncompliance or subtherapeutic cyclosporine levels. The use of an OKT3-based sequential induction protocol resulted in a decreased incidence of acute rejection. Renal function was preserved, and the incidence of infection was not increased. Long-term outcome analysis of this protocol shows excellent patient survival and the near absence of late or chronic rejection.