A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults

Thierry-Carstensen, Birgit; Jordan, Karina; Uhlving, Hilde Hylland; Dalby, Tine; Sørensen, Charlotte; Jensen, Anders Møller; Heilmann, Carsten

doi:10.1016/j.vaccine.2012.06.073

Cited by 33 publications

(19 citation statements)

References 40 publications

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“…Poor responses to diphtheria toxoid are thus difficult to interpret. However, in the same study the majority of adults achieved a level of 1 IU/ml following diphtheria vaccination [26]. In our experience, many otherwise normal individuals do not reach this level following immunization.…”

Section: Critical Analysis Of the Esid/pagid Criteria For Cvidsupporting

confidence: 49%

“…We suggest that patients' responses should be compared with age-matched controls undergoing immunization. A recent study of adults suggested that a level of 1 IU/ml is achieved by the majority of individuals receiving a single tetanus toxoid dose [26]. This threshold should therefore be applied to patients undergoing tetanus vaccination.…”

Section: Critical Analysis Of the Esid/pagid Criteria For Cvidmentioning

confidence: 99%

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New diagnostic criteria for common variable immune deficiency (CVID), which may assist with decisions to treat with intravenous or subcutaneous immunoglobulin

Ameratunga

Woon

Gillis

et al. 2013

Clinical and Experimental Immunology

199

196

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SummaryCommon variable immune deficiency (CVID) is the most frequent symptomatic primary immune deficiency in adults. The standard of care is intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (scIG) therapy. The cause of CVID is currently unknown, and there is no universally accepted definition of CVID. This creates problems in determining which patients will benefit from IVIG/scIG treatment. In this paper, we review the difficulties with the commonly used European Society of Immune Deficiencies (ESID) and the Pan American Group for Immune Deficiency (PAGID) definition of CVID. We propose new criteria for the diagnosis of CVID, which are based on recent scientific discoveries. Improved diagnostic precision will assist with treatment decisions including IVIG/ scIG replacement. We suggest that asymptomatic patients with mild hypogammaglobulinaemia are termed hypogammaglobulinaemia of uncertain significance (HGUS). These patients require long-term follow-up, as some will evolve into CVID.

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Section: Critical Analysis Of the Esid/pagid Criteria For Cvidsupporting

confidence: 49%

Section: Critical Analysis Of the Esid/pagid Criteria For Cvidmentioning

confidence: 99%

New diagnostic criteria for common variable immune deficiency (CVID), which may assist with decisions to treat with intravenous or subcutaneous immunoglobulin

Ameratunga

Woon

Gillis

et al. 2013

Clinical and Experimental Immunology

199

196

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“…They determined that the estimated Tdap vaccine effectiveness was approximately 66%. In a large randomized clinical trial involving 802 participants aged 18 to 55 years who had completed childhood vaccination with DTP and were given monocomponent Tdap in that study, the antibodies to PT were mounted in 92% at 1 month after vaccine administration (530). In 2004, Purdy et al conducted a cost-benefit analysis to determine whether Tdap administration in adolescents and adults would be a good strategy (531).…”

Section: Tdap Immunization For Adolescents and Adultsmentioning

confidence: 99%

Pertussis: Microbiology, Disease, Treatment, and Prevention

et al. 2016

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SUMMARYPertussis is a severe respiratory infection caused byBordetella pertussis, and in 2008, pertussis was associated with an estimated 16 million cases and 195,000 deaths globally. Sizeable outbreaks of pertussis have been reported over the past 5 years, and disease reemergence has been the focus of international attention to develop a deeper understanding of pathogen virulence and genetic evolution ofB. pertussisstrains. During the past 20 years, the scientific community has recognized pertussis among adults as well as infants and children. Increased recognition that older children and adolescents are at risk for disease and may transmitB. pertussisto younger siblings has underscored the need to better understand the role of innate, humoral, and cell-mediated immunity, including the role of waning immunity. Although recognition of adult pertussis has increased in tandem with a better understanding ofB. pertussispathogenesis, pertussis in neonates and adults can manifest with atypical clinical presentations. Such disease patterns make pertussis recognition difficult and lead to delays in treatment. Ongoing research using newer tools for molecular analysis holds promise for improved understanding of pertussis epidemiology, bacterial pathogenesis, bioinformatics, and immunology. Together, these advances provide a foundation for the development of new-generation diagnostics, therapeutics, and vaccines.

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“…Vaccine responses in normal controls have been published (50, 52, 53). Patients receiving a single booster dose of tetanus toxoid should achieve an antibody response of at least 1 IU/ml (50).…”

Section: New Diagnostic Criteria For Cvidmentioning

confidence: 99%

“…Patients receiving a single booster dose of tetanus toxoid should achieve an antibody response of at least 1 IU/ml (50). Although a response of 1 IU/ml has been suggested following diphtheria immunization, our experience and original immunization studies show that this vaccine is much less immunogenic than the tetanus vaccine (50). Even otherwise healthy individuals may fail to reach this level, particularly persons over 50 years of age.…”

Section: New Diagnostic Criteria For Cvidmentioning

confidence: 99%

Comparison of Diagnostic Criteria for Common Variable Immunodeficiency Disorder

et al. 2014

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Common variable immunodeficiency disorders (CVIDs) are the most frequent symptomatic primary immune deficiency condition in adults. The genetic basis for the condition is not known and no single clinical feature or laboratory test can establish the diagnosis; it has been a diagnosis of exclusion. In areas of uncertainty, diagnostic criteria can provide valuable clinical information. Here, we compare the revised European society of immune deficiencies (ESID) registry (2014) criteria with the diagnostic criteria of Ameratunga et al. (2013) and the original ESID/pan American group for immune deficiency (ESID/PAGID 1999) criteria. The ESID/PAGID (1999) criteria either require absent isohemagglutinins or impaired vaccine responses to establish the diagnosis in patients with primary hypogammaglobulinemia. Although commonly encountered, infective and autoimmune sequelae of CVID were not part of the original ESID/PAGID (1999) criteria. Also excluded were a series of characteristic laboratory and histological abnormalities, which are useful when making the diagnosis. The diagnostic criteria of Ameratunga et al. (2013) for CVID are based on these markers. The revised ESID registry (2014) criteria for CVID require the presence of symptoms as well as laboratory abnormalities to establish the diagnosis. Once validated, criteria for CVID will improve diagnostic precision and will result in more equitable and judicious use of intravenous or subcutaneous immunoglobulin therapy.

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A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults

Cited by 33 publications

References 40 publications

New diagnostic criteria for common variable immune deficiency (CVID), which may assist with decisions to treat with intravenous or subcutaneous immunoglobulin

New diagnostic criteria for common variable immune deficiency (CVID), which may assist with decisions to treat with intravenous or subcutaneous immunoglobulin

Pertussis: Microbiology, Disease, Treatment, and Prevention

Comparison of Diagnostic Criteria for Common Variable Immunodeficiency Disorder

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