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Abstract The severity of lung disease in cystic fibrosis may be related to the genetic propensity of the host to produce tumor necrosis fector [alpha] (TNF-[alpha]). A polymorphism in the [...]

The Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine appears to be effective in preventing whooping cough. Over a 3.5-year period, researchers randomly assigned 8,532 infants to receive DTaP or whole-cell DTP vaccine. DTP was 94% effective in preventing severe whooping cough and DTaP was 86% effective. Both vaccines were less effective in preventing mild whooping cough and even less effective in preventing any illness with cough as the principal symptom., Background. A household contact substudy was performed as part of a prospective, cohort pertussis vaccine efficacy trial in Germany. Design. Infants received four doses of either the Lederle/Takeda acellular pertussis component diphtheria-tetanus toxoids (DTP) vaccine (DTaP) or Lederle whole-cell component DTP vaccine at 3, 4.5, 6, and 15 to 18 months of age (Wyeth-Lederle Vaccines and Pediatrics, Pearl River, NY). An open control group received three doses of diphtheria and tetanus toxoids vaccine (DT) at 3, 4.5, and 15 to 18 months of age. Vaccine efficacy rates were calculated using a number of principal and ancillary case definitions for primary, secondary, and noncases by analyzing secondary attack rates in study infants after exposure to pertussis in the household using 7- to 28- and 7- to 42-day postexposure observation periods and the inclusion and the exclusion of noncases who received macrolide antibiotics or trimethoprim-sulfamethoxazole during the exposure period. Results. During a 3.5-year study period, 10 271 infants (DTP or DTaP, n = 8532; DT, n = 1739) were enrolled and actively followed along with all household members for cough illnesses. Depending on the case definition, 160 to 519 household exposures to pertussis were identified. In general, secondary attack rates in DT recipients were low and this was primarily because of the frequent use of antimicrobial prophylaxis. Using the principal case definitions and the exclusion of noncases who received macrolide antibiotics or trimethoprimsulfamethoxazole during the exposure period and the 7-to 42-day observation period, the efficacy of DTP against cough illness of [is greater than or equal to] 7 days duration caused by Bordetella pertussis was 84% (95% confidence interval [CI] = 65-93) and that of DTaP was 58% (95% CI = 30-75). Using similar criteria, the efficacy against typical pertussis ([is greater than or equal to] 21 days of cough with either paroxysms, whoop, or posttussive vomiting) was 94% (95% CI = 77-99) and 86% (95% CI = 62-95) for DTP and DTaP, respectively. The efficacy against any cough illness (with or without) laboratory confirmation was 54% (95% CI = 32-69) and 38% (95% CI = 13-56) for DTP and DTaP, respectively. Conclusion. This household contact substudy within our cohort study, with active investigator-generated surveillance, was a severe test of vaccine efficacy. Both vaccines (DTP and DTaP) are better at preventing typical pertussis than mild illness. When case definitions similar to those in other recent trials are used, the Lederle/ Takeda vaccine has an efficacy similar to other multicomponent DTaP vaccines. Pediatrics 1998;102:546-553; Bordetella pertussis, acellular pertussis vaccine, whole cell pertussis vaccine, household contact, vaccine efficacy., ABBREVIATIONS. DTaP, diphtheria-tetanus toxoids, acellular pertussis vaccine, adsorbed; DTP, diphtheria-tetanus toxoids, whole cell pertussis vaccine, adsorbed; DT, diphtheria and tetanus toxoids vaccine; NPS, nasopharyngeal specimen; PWV, paroxysms, whoop, or posttussive [...]

The Lederle/Takeda acellular pertussis component diphtheria-tetanus toxoids, pertussis (DTaP) vaccine may provide immunity against whooping cough caused by both Bordetella pertussis and Bordetella parapertussis. Of 10,271 infants, 4,273 receiving DTaP demonstrated a vaccine efficacy of 72% for B pertussis, compared to 83% in 4,259 receiving whole-cell DTP vaccine. Severe reactions were significantly higher in the DTP group. Others received a DT vaccine with no pertussis component. DTaP, but not DTP, appeared to confirm some immunity to B parapertussis infections as well as B pertussis., Background. The goal of the trial was to determine the efficacy of a multicomponent acellular pertussis vaccine against Bordetella illnesses in comparison with a whole-cell product and DT. Design. In a randomized, double-blind fashion, 2- to 4-month-old infants received 4 doses of either DTP or DTaP vaccine at 3, 4.5, 6, and 15 to 18 months of age. The controls received 3 doses (3, 4.5, 15 to 18 months of age) of DT vaccine. The DTP vaccine was Lederle adsorbed vaccine (licensed in the United States) and DTaP was Lederle/Takeda adsorbed vaccine. Follow-up for vaccine efficacy started 2 weeks after the third dose (DTP/DTaP) and at the same age (6.5 months) in DT recipients. Reactogenicity of all doses of all three vaccines was documented by standardized parent diary cards. In addition, all subjects were monitored for respiratory illnesses and serious adverse events by biweekly phone calls. Results. From May 1991 to January 1993, a total of 10 271 infants were enrolled: 8532 received either DTP or DTaP and 1739 received DT. Specific efficacy against B pertussis infections with cough [is greater than or equal to] 7 days duration was 83% (95% confidence interval [CI]: 76-88) and 72% (95% CI: 62-79) for DTP and DTaP, respectively; results for DTP and DTaP based on [is greater than or equal to] 21 days of cough with either paroxysms, whoop or posttussive vomiting (PWV) were 93% (95% CI: 89-96) and 83% (95% CI: 76-88), respectively. For DTaP vaccine, efficacy was higher after the fourth dose as compared with its efficacy after the third dose (78% vs 62% for cough [is greater than or equal to] 7 days and 85% vs 76% for cough [is greater than or equal to] 21 days with PWV). For DTP vaccine, efficacy was less varied after the third and fourth dose (78% vs vs 85% for cough [is greater than or equal to] 7 days and 93% vs 93% for cough [is greater than or equal to] 21 days with PWV). In contrast with DTP, the DTaP vaccine had some efficacy against B parapertussis infection (point estimate for cough [is greater than or equal to] 7 days: 31% [95% CI: -10-56]). All vaccines were generally well-tolerated. However, side reactions were significantly less after DTaP compared with DTP. Conclusions. Like other multicomponent acellular pertussis vaccines, the Lederle/Takeda DTaP vaccine demonstrated good efficacy against mild and typical pertussis due to B pertussis infections. Interestingly, it also may have some efficacy against B parapertussis. Based on the results of this trial, the vaccine was licensed in the United States in December 1996 for all 5 doses of the currently recommended immunization schedule in this country. Pediatrics 1998;101:1-11; acellular pertussis vaccine, whole-cell pertussis vaccine, double blind, B pertussis, B parapertussis., ABBREVIATIONS. DTaP, diphtheria-tetanus toxoids, acellular pertussis vaccine, adsorbed; DTP, diphtheria-tetanus toxoids, whole cell pertussis vaccine, adsorbed; DT, diphtheria-tetanus vaccine; FHA, filamentous hemagglutinin; PT, pertussis toxin; PCR, polymerase chain reaction; IgG, [...]