Safety and immunogenicity of six acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four- to six-year-old children.

OBJECTIVE: To evaluate the safety and immunogenicity of 6 different acellular pertussis vaccines combined with diphtheria and tetanus toxoids (DTaP) and with 1 licensed whole-cell pertussis vaccine (DTwP) as a fifth dose in children who had previously received the same DTaP, a different DTaP, or DTwP as primary and fourth-dose vaccinations. METHODS: Healthy 4- to 6-year-old children were enrolled at 5 National Institute of Allergy and Infectious Diseases Vaccine Treatment and Evaluation Units to receive a fifth dose of a DTaP or DTwP vaccine. All had been randomly assigned to receive 3 primary doses of DTaP or DTwP at 2, 4, and 6 months and a fourth-dose booster at 15 to 20 months of age as part of earlier National Institutes of Health multicenter acellular pertussis vaccine trials. Parents recorded the occurrence and magnitude of fever, irritability, and injection site redness, swelling, and pain for 3 days after vaccination. Sera obtained before and 1 month after the booster vaccination were analyzed by enzyme-linked immunosorbent assay for antibody to pertussis toxin, filamentous hemagglutinin, fimbriae, pertactin, and diphtheria and tetanus toxoid. Safety and/or immunogenicity data are reported for 317 children who received DTaP and 10 children who received DTwP. RESULTS: Fever and moderate or severe irritability were uncommon following the fifth dose of DTaP vaccine and were generally less frequent than following the fourth dose. However, for the DTaP vaccine groups, redness, swelling, and pain increased in prevalence compared with the fourth dose. The time course and frequency of reactions following DTaP vaccination were generally similar in children who received the same DTaP, a different DTaP, or DTwP for previous doses in the 5- dose series. No significant differences among the DTaP vaccines were detected in the occurrence of reactions, but the statistical power to detect differences was limited by sample size. Significant increases in antibodies directed against the included antigens were observed for all DTaP vaccines in paired pre- and post-fifth dose sera. Post-fifth dose antibody concentrations differed significantly among the DTaP vaccines. Some children in the study showed an antibody response to an antigen not reported to be in the DTaP vaccine. CONCLUSION: All the studied DTaP vaccines performed similarly with regard to reactions, whether given as a fifth sequential dose of the same vaccine, a mix of different DTaP vaccines in the 5-dose sequence, or after 3 DTwP and 1 DTaP vaccinations. Large injection site reactions occurred more frequently after the fifth dose of DTaP than after the previous 4 doses. A fifth dose of all DTaP vaccines induced an antibody response to those antigens contained in the vaccine. No DTaP was consistently most or least reactogenic or immunogenic.

The epidemiology of Wegener's granulomatosis. Estimates of the five-year period prevalence, annual mortality, and geographic disease distribution from population-based data sources.

OBJECTIVE: To estimate the prevalence, annual mortality, and geographic distribution of Wegener's granulomatosis. METHODS: Analysis of national vital statistics data and hospitalization data from a national survey and from all New York State inpatient facilities. RESULTS: Between 1979 and 1988, 1,784 death certificates in the United States listed Wegener's granulomatosis as a cause of death. Nationally, an estimated 10,771 hospitalizations included Wegener's granulomatosis among the discharge diagnoses. In New York State, there were 978 hospitalizations among 571 individuals with Wegener's granulomatosis. CONCLUSION: The prevalence of Wegener's granulomatosis in the United States is approximately 3.0 per 100,000 persons. Clear differences in the geographic distribution of Wegener's granulomatosis are apparent when analysis consider rates of disease in individual counties. Contrary to previous reports, associations between disease exacerbations and season were not apparent.

Demographic and behavioral predictors of Trichomonas vaginalis infection among pregnant women. The Vaginal Infections and Prematurity Study Group.

There is little available information on the demographic and behavioral factors associated with Trichomonas vaginalis in pregnant women. Among 13,816 women from six urban clinic centers, the prevalence rate by culture at mid-pregnancy was 12.6%. Women colonized with T vaginalis were significantly more likely to be black, cigarette smokers, unmarried, and less educated (all P less than .01). Several behavioral factors associated with T vaginalis included greater numbers of sexual partners both lifetime and in the last year, 5 years or more of sexual activity, and a history of gonorrhea (all P less than .01). Trichomonas vaginalis-colonized women were less sexually active in the preceding month compared with uncolonized women (P less than .01). Women using either barrier or oral contraception in the 6 months before becoming pregnant were far less likely to be colonized (P less than .01). Other factors such as age, gravidity, income level, age at first coitus, and use of antibiotics, alcohol, or douche during pregnancy were not independently associated with T vaginalis colonization. Because many of the factors predictive of increased risk of colonization have also been shown to be associated with adverse pregnancy outcome, they should be considered in assessing the association of T vaginalis with adverse pregnancy outcome.

Infections complicating low-risk cesarean sections in community hospitals: efficacy of antimicrobial prophylaxis.

A prospective study of women with low-risk cesarean sections was conducted in four community hospitals to determine the frequency of postoperative infections and identify factors predisposing to endometritis and wound infection. Low-risk cesarean section was defined as a scheduled procedure without an urgent indication, with any duration of ruptured membranes being less than or equal to 12 hours. In a cohort of 1863 patients, 26 (1.4%) developed endometritis and 21 (1.1%) had wound infections. Primary cesarean section was associated with endometritis in the cohort (p less than 0.01) and in a retrospective study with the same cases as in the cohort (p = 0.01). Absence of antibiotic prophylaxis was associated with endometritis (p less than or equal to 0.013) or endometritis with wound infection (p less than 0.01) in both studies. Without prophylaxis 37 such infections occurred in 957 (3.7%) women; with prophylaxis eight infections occurred in 906 (0.9%) women. Routine timely antibiotic prophylaxis in low-risk cesarean sections could lead to an annual national savings of approximately $9 million.