Comparative Efficacy of the Lederle/Takeda Acellular Pertussis Component DTP (DTaP) Vaccine and Lederle Whole-Cell Component DTP Vaccine in German Children After Household Exposure

Heininger, Ulrich; Cherry, James D.; Stehr, K.; Schmitt‐Grohé, Sabina; Überall, Michael A.; Laussucq, Suzanne; Eckhardt, Thomas; Meyer, Martin; Gornbein, Jeffrey

doi:10.1542/peds.102.3.546

Cited by 65 publications

(32 citation statements)

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“…When stratified according to age, the VE for 3 pertussis vaccine doses, compared with no vacci- (15) nation, was consistently high (range: 93.3-98.4%) ( Table 3). Among 558 children who received 4 valid pertussis vaccinations, dose 4 was given early in the acceptable age range for dose 4 (ie, age of Յ13 months, the acceptable age for vaccination plus a 1-month grace period) for 8 (13%) of 63 case subjects and 25 (5%) of 495 control subjects (P ϭ .02).…”

Section: Vementioning

confidence: 99%

“…12,13 In contrast, the vaccine efficacy estimate for the Wyeth-Lederle DTP vaccine, administered in a 4-dose series, was 94% in a German clinical trial. 14,15 In 1991 and 1992, 2 acellular pertussis vaccines (containing purified components of B pertussis) combined with diphtheria and tetanus toxoids (diphtheria-tetanus toxoids-acellular pertussis [DTaP]) were licensed for use as the fourth and fifth doses of the vaccination series among children who had received 3 doses of whole-cell DTP. On the basis of results of efficacy studies in Europe, [12][13][14][15][16][17] approximately one quarter of reported cases were among unvaccinated children 6 to 59 months of age, 1 the vaccination status was not documented for all cases; for those case children with documented vaccination status, the vaccine type, lot, and manufacturer data were usually unavailable.…”

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confidence: 99%

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Pertussis Vaccine Effectiveness Among Children 6 to 59 Months of Age in the United States, 1998–2001

et al. 2005

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ABSTRACT. Background. Despite the dramatic pertussis decrease since the licensure of whole-cell pertussis (diphtheria-tetanus toxoids-pertussis [DTP]) vaccines in the middle 1940s, pertussis remains endemic in the United States and can cause illness among persons at any age; >11 000 pertussis cases were reported in 2003. Since July 1996, in addition to 2 DTP vaccines already in use, 5 acellular pertussis (diphtheria-tetanus toxoids-acellular pertussis [DTaP]) vaccines were licensed for use among infants; 3 DTaP vaccines were distributed widely during the study period. Because of the availability of 3 DTaP and 2 DTP vaccines and the likelihood of the vaccines being used interchangeably to vaccinate children with the recommended 5-dose schedule, measuring the effectiveness of the pertussis vaccines was a high priority.Objective. To measure the pertussis vaccine effectiveness (VE) among US children 6 to 59 months of age.Design. We conducted a case-control study in the Cincinnati, Ohio, metropolitan area, Colorado, Idaho, and Minnesota.Participants. Confirmed pertussis cases among children 6 to 59 months of age at the time of disease onset, with onset in 1998 -2001, were included. For each case subject, 5 control children were matched from birth certificate records, according to the date of birth and residence.Outcome Measures. A standardized questionnaire was used to obtain vaccination data from parents and providers. Parents/guardians were asked about demographic characteristics, child care attendance, the number of household members who stayed at the same home as the enrolled child for >2 nights per week, and cough illness of >2-week duration among these household members in the month before the case patient's cough onset. Pertussis vaccine doses among case children were counted as valid if they were received >14 days before the cough onset date ("valid period"). The age of the case patient (in days) at the end of the valid period was determined, and doses of vaccine for the matched control subjects were counted as valid if they were received by that age. Conditional logistic regression models were used to estimate the matched odds ratios (ORs) for pertussis according to the number of pertussis vaccine doses. The VE was calculated with the following formula: (1 ؊ OR) ؋ 100. Because the pertussis antigen components or amounts differed according to vaccine, the VE of 3 or 4 doses of DTP and/or DTaP was estimated according to the recorded vaccine manufacturer and vaccine type.Results. All enrolled children (184 case subjects and 893 control subjects) had their vaccine history verified. The proportions of children who received 0, 1 or 2, 3, and >4 pertussis (DTP and/or DTaP) vaccine doses among case subjects were 26%, 14%, 26%, and 34% and among control subjects were 2%, 8%, 33%, and 57%, respectively. Compared with 0 doses, the unadjusted VE estimate for 1 or 2 pertussis doses was 83.6% (95% confidence interval [CI]: 61.1-93.1%), that for 3 doses was 95.6% (95% CI: 89.7-98.0%), and for >4 doses was 97.7% (95% CI: 94...

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Section: Vementioning

confidence: 99%

mentioning

confidence: 99%

Pertussis Vaccine Effectiveness Among Children 6 to 59 Months of Age in the United States, 1998–2001

et al. 2005

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“…The clinical aspects of this study were carried out when pertussis was widespread in Germany, so that finding some PCR-positive cases is not surprising, as asymptomatic or mild infections with B. pertussis are common [4,6,7]. Importantly, there were no apparent differences in the histopathologic findings between cases that were initially either PCR-positive or PCR-negative.…”

Section: Discussionmentioning

confidence: 99%

The respiratory pathology in infants with sudden unexpected deaths in whom respiratory specimens were initially PCR-positive or PCR-negative for Bordetella pertussis

et al. 2011

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Background In a previous controlled study, we investigated the relationship between Bordetella pertussis infections and sudden unexpected deaths among German infants (sudden infant death syndrome, SIDS). In this present study, we investigated further the respiratory pathology in a subset of infants in the original study. Methods Originally, there were 234 infants with SIDS and, of these, 12 had either a nasopharyngeal swab (NPS) or a tracheal swab specimen (TS) that was positive for B. pertussis by polymerase chain reaction (PCR). Here, tissue specimens from eight infants who were originally PCRpositive were compared with tissue specimens from seven infants in whom the original PCR studies were negative. Results The histopathologic diagnoses were as follows: 14 of 15 had pulmonary edema and the remaining case had early diffuse alveolar damage. Although 14 of 15 cases had some histologic or clinical evidence suggesting respiratory tract infection, the features were more consistent with a viral etiology, and in none were the findings typical of respiratory disease attributable to B. pertussis. ConclusionsThe findings in this present investigation do not support a direct role of B. pertussis at the site of infection (ciliated epithelium) in the causation of SIDS. The clinical aspects of this study were carried out in the 1990s when pertussis was widespread in Germany. Therefore, the original finding of some PCR-positive cases is not surprising. The possibility that B. pertussis infection could still be a factor in some SIDS cases, e.g., by a systemic release of toxins, cannot be definitely ruled out.

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“…[6][7][8][9] Briefly, this was a longitudinal cohort study in 227 private practices in which the Lederle/Takeda diphtheria-tetanus acellular pertussis component (DTaP) and the Lederle diphtheriatetanus whole-cell pertussis component (DTP) vaccines were administered in a double-blind, randomized manner. The diphtheria-tetanus vaccine (DT) group was open based on parent preference.…”

Section: Methodsmentioning

confidence: 99%

“…[1][2][3][4][5][6][7][8][9][10][11] Clinical investigations in conjunction with vaccine efficacy trials led to the realization that a significant percentage of Bordetella pertussis infections result in relatively mild illnesses of short duration. [1][2][3][4][5][6][7][8]10,11 A number of polymerase chain reaction (PCR) assays with primers derived from 4 different chromosomal regions have been developed for the diagnosis of B pertussis and B parapertussis infections and have been evaluated in multiple studies by comparison with culture and clinically typical pertussis. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] In the investigational setting, however, standardized serologic assays have proven to be the most sensitive technique for the diagnosis of Bordetella spp infections (reviewed in reference 29).…”

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confidence: 99%

Clinical Validation of a Polymerase Chain Reaction Assay for the Diagnosis of Pertussis by Comparison With Serology, Culture, and Symptoms During a Large Pertussis Vaccine Efficacy Trial

et al. 2000

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ABSTRACT. Objective. To assess the diagnostic sensitivity and specificity of a Bordetella pertussis polymerase chain reaction (PCR) assay using nasopharyngeal (NP) specimens from subjects with cough illnesses participating in a large pertussis vaccine efficacy trial.Design. From 1991 to 1994, we conducted a large pertussis vaccine efficacy trial in Germany to determine the efficacy of the Lederle/Takeda acellular pertussis component diphtheria-tetanus toxoids in comparison with the Lederle whole-cell component diphtheria-tetanus toxoids vaccine. In the final year of the follow-up period of this trial, a second NP specimen for PCR, in addition to a culture specimen and blood for specific serology (enzyme-linked immunosorbent assay), was collected by use of a Dacron swab in subjects or family members with cough illnesses >7 days duration or in subjects with exposure to a cough illness in a household member to establish a diagnosis of B pertussis infection. Oligonucleotide primers (pTp1 and pTp2) that amplify a 191-bpsized DNA fragment from the pertussis toxin operon, which is specific for B pertussis, were used. The PCRamplified products were visualized by dot blot analysis followed by hybridization with a digoxigenin labeled probe and rated as 1؉, 2؉, or 3؉ in comparison with positive controls representing ϳ1 to 10, 11 to 50, and >50 B pertussis organisms, respectively. In the present analysis, we compare PCR findings with those of serology, culture, positive household contact, and clinical characteristics of cough illnesses.Results. Of 392 subjects with NP specimens obtained for PCR, 376 also had NP specimens collected for culture and 282 had serum specimens. PCR and culture were positive in 86 (22%) and 23 (6%) subjects, respectively. Of the positive PCR specimens, 40 were rated 3؉, 32 were rated 2؉, and 14 were rated 1؉; 3؉ positive specimens were more prevalent among DT recipients compared with pertussis vaccine recipients. Illnesses in subjects with 3؉ positive PCR results were more typical of pertussis than were those in subjects with 2؉ and 1؉ positive results with a mean duration of cough of 48 days versus 43 and 42 days, respectively; presence of paroxysms, whoop or vomiting in 38% versus 17% and 10%, respectively; and a clinical diagnosis of definite or probable pertussis by the investigators of 26% versus 7% and 4%, respectively. Using serologic evidence of infection as the standard, sensitivity of PCR was 61%, and specificity was 88%. For 3؉ positive PCR results, the respective values were 42% and 97%.Conclusion. Our findings demonstrate that PCR is more sensitive than conventional culture for the diagnosis of pertussis. They also demonstrate a high specificity of PCR when serology with or without other confirmative criteria (culture and household contact) is used as the reference. Analysis of semiquantitative PCR results revealed that subjects with a 3؉ PCR more frequently experienced typical illness compared with patients with 1؉ or 2؉ PCR. Although specific serologic study remains a necessity in pe...

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Comparative Efficacy of the Lederle/Takeda Acellular Pertussis Component DTP (DTaP) Vaccine and Lederle Whole-Cell Component DTP Vaccine in German Children After Household Exposure

Cited by 65 publications

References 30 publications

Pertussis Vaccine Effectiveness Among Children 6 to 59 Months of Age in the United States, 1998–2001

Pertussis Vaccine Effectiveness Among Children 6 to 59 Months of Age in the United States, 1998–2001

The respiratory pathology in infants with sudden unexpected deaths in whom respiratory specimens were initially PCR-positive or PCR-negative for Bordetella pertussis

Clinical Validation of a Polymerase Chain Reaction Assay for the Diagnosis of Pertussis by Comparison With Serology, Culture, and Symptoms During a Large Pertussis Vaccine Efficacy Trial

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