Comparative Study of Different Sources of Pertussis Toxin (PT) as Coating Antigens in IgG Anti-PT Enzyme-Linked Immunosorbent Assays

Kapasi, Aditi A.; Meade, Bruce D.; Plikaytis, Brian D.; Pawloski, Lucia; Martin, Monte D.; Yoder, Sandra; Rock, Michael T.; Coddens, Séverine; Haezebroeck, Valérie; Fievet-Groyne, Françoise; Bixler, Garvin S.; Jones, Charles; Hildreth, Stephen W.; Edwards, Kathryn M.; Messonnier, Nancy E.; Tondella, M. Lucia

doi:10.1128/cvi.05460-11

Cited by 25 publications

(9 citation statements)

References 26 publications

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“…Pertussis IgG enzyme-linked immunosorbent assays (ELISAs) were used to quantify the concentration of antibodies to PT, FHA, PRN, and FIM, expressed in ELISA Units per milliliter (EU/mL). (10) The lower limit of quantitation (LLOQ) was 3 EU/mL for FHA and 4 EU/mL for PT, PRN and FIM. Anti-tetanus toxoid antibodies were measured by IgG ELISA using the World Health Organization (WHO) International Standard for Tetanus Immunoglobulin, Human, Lot TE3.…”

Section: Methodsmentioning

confidence: 97%

Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants

Muñoz

Bond

Maccato

et al. 2014

JAMA

442

389

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Importance Maternal immunization with tetanus toxoid and reduced diphtheria toxoid acellular pertussis (Tdap) vaccine could prevent infant pertussis. The effect of vaccine-induced maternal antibodies on infant responses to diphtheria and tetanus toxoids acellular pertussis (DTaP) immunization is unknown. Objective To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to DTaP. Design, Setting and Participants Phase I, randomized, double-masked, placebo-controlled clinical trial conducted in private (Houston) and academic (Durham, Seattle) obstetric practices from 2008 to 2012. Forty eight healthy 18–45 year-old pregnant women received Tdap (n=33) or placebo (n=15) at 30–32 weeks’ gestation with cross-over Tdap immunization postpartum. Interventions Tdap vaccination at 30–32 weeks’ gestation or post-partum. Outcome Measures Primary: Maternal and infant adverse events, pertussis illness and infant growth and development (Bayley-III screening test) until 13 months of age. Secondary: Antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months postpartum, and in infants at birth, 2 months, and after the third (7 months) and fourth (13 months) doses of DTaP. Results All participants delivered healthy newborns. No Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 78.8% (95% CI: 61.1%, 91.0%) and 80% (CI: 51.9%, 95.7%) pregnant and postpartum women, respectively. Injection site pain was the predominant symptom. Systemic symptoms were reported in 36.4% (CI: 20.4%, 54.9%) and 73.3% (CI: 44.9%, 92.2%) pregnant and postpartum women, respectively. Malaise and myalgia were most common. Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy and in their infants at birth and at age 2 months when compared to infants of women immunized postpartum. Antibody responses in infants of Tdap recipients during pregnancy were modestly lower after 3 DTaP doses, but not different following the fourth dose. Conclusions and Relevance This preliminary safety assessment did not find an increased risk of adverse events among women who received Tdap vaccine at 30–32 weeks’ gestation or their infants. Maternal immunization with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap vaccination during pregnancy. Trial Registration ClinicalTrials.gov, study identifier: NCT00707148. URL: http://www.clinicaltrials.gov

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Section: Methodsmentioning

confidence: 97%

Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants

Muñoz

Bond

Maccato

et al. 2014

JAMA

442

389

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“…Three of four participants used the same reference serum (the CBER standard or the equivalent WHO reference serum). Among those was the only ELISA (from the CDC) in which one dilution of test samples was used (233). The authors concluded that using the same reference serum may be the dominant important parameter for comparability.…”

Section: Serodiagnosis Of Pertussismentioning

confidence: 99%

Laboratory Diagnosis of Pertussis

2015

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SUMMARYThe introduction of vaccination in the 1950s significantly reduced the morbidity and mortality of pertussis. However, since the 1990s, a resurgence of pertussis has been observed in vaccinated populations, and a number of causes have been proposed for this phenomenon, including improved diagnostics, increased awareness, waning immunity, and pathogen adaptation. The resurgence of pertussis highlights the importance of standardized, sensitive, and specific laboratory diagnoses, the lack of which is responsible for the large differences in pertussis notifications between countries. Accurate laboratory diagnosis is also important for distinguishing between the several etiologic agents of pertussis-like diseases, which involve both viruses and bacteria. If pertussis is diagnosed in a timely manner, antibiotic treatment of the patient can mitigate the symptoms and prevent transmission. During an outbreak, timely diagnosis of pertussis allows prophylactic treatment of infants too young to be (fully) vaccinated, for whom pertussis is a severe, sometimes fatal disease. Finally, reliable diagnosis of pertussis is required to reveal trends in the (age-specific) disease incidence, which may point to changes in vaccine efficacy, waning immunity, and the emergence of vaccine-adapted strains. Here we review current approaches to the diagnosis of pertussis and discuss their limitations and strengths. In particular, we emphasize that the optimal diagnostic procedure depends on the stage of the disease, the age of the patient, and the vaccination status of the patient.

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“…These results led to a recently completed study to compare the effects of four sources of PT antigen preparations on four different ELISA methods. Results demonstrated that if the preparations are highly purified and well qualified and the ELISAs are calibrated to a reference standard and well validated, these different PT sources could be interchangeably used (13).…”

Section: Discussionmentioning

confidence: 99%

“…Methods for the anti-PT IgG ELISA have been previously described (13,19). The diagnostic ELISA is a single-point, single 1:100 dilution assay that contains six ready-to-use standards and three ready-to-use controls (negative, intermediate, and positive).…”

Section: Methodsmentioning

confidence: 99%

Does Tetanus-Diphtheria-Acellular Pertussis Vaccination Interfere with Serodiagnosis of Pertussis Infection?

Pawloski

Kirkland

Baughman

et al. 2012

Clin Vaccine Immunol

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ABSTRACTAn anti-pertussis toxin (PT) IgG enzyme-linked immunosorbent assay (ELISA) was analytically validated for the diagnosis of pertussis at a cutoff of 94 ELISA units (EU)/ml. Little was known about the performance of this ELISA in the diagnosis of adults recently vaccinated with tetanus-diphtheria-acellular pertussis (Tdap) vaccine, which contains PT. The goal of this study was to determine when the assay can be used following Tdap vaccination. A cohort of 102 asymptomatic health care personnel (HCP) vaccinated with Tdap (Adacel; Sanofi Pasteur) were aged 19 to 79 years (median, 47 years) at vaccination. For each HCP, specimens were available for evaluation at 2 to 10 time points (prevaccination to 24 months postvaccination), and geometric mean concentrations (GMC) for the cohort were calculated at each time point. Among 97 HCP who responded to vaccination, a mixed-model analysis with prediction and tolerance intervals was performed to estimate the time at which serodiagnosis can be used following vaccination. The GMCs were 8, 21, and 9 EU/ml at prevaccination and 4 and 12 months postvaccination, respectively. Eight (8%) of the 102 HCP reached antibody titers of ≥94 EU/ml during their peak response, but none had these titers by 6 months postvaccination. The calculated prediction and tolerance intervals were <94 EU/ml by 45 and 75 days postvaccination, respectively. Tdap vaccination 6 months prior to testing did not confound result interpretation. This seroassay remains a valuable diagnostic tool for adult pertussis.

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Comparative Study of Different Sources of Pertussis Toxin (PT) as Coating Antigens in IgG Anti-PT Enzyme-Linked Immunosorbent Assays

Abstract: In an effort to improve the reliability and reproducibility of serological assays for Bordetella pertussis, a collaborative study was conducted to compare four different sources of pertussis toxin (

Cited by 25 publications

References 26 publications

Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants

Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants

Laboratory Diagnosis of Pertussis

Does Tetanus-Diphtheria-Acellular Pertussis Vaccination Interfere with Serodiagnosis of Pertussis Infection?

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