Viscerotropic disease: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

Gershman, Mark D.; Staples, J. Erin; Bentsi-Enchill, Adwoa; Breugelmans, J. Gabrielle; Brito, Glacus S.; Camacho, Luiz Antônio Bastos; Cottin, Pascale; Domingo, Cristina; Durbin, Anna P.; Gascón, Joaquim; Guenaneche, Fouzia; Hayes, Edward B.; Jelenik, Zsuzsanna; Khromava, Alena; Martins, Reinaldo de Menezes; Wilson, M; Massy, Nathalie; Nasidi, Abdulsalami; Niedrig, Matthias; Sherwat, Adam; Tsai, Theodore F.; Vilella, Anna; Wilson, Mary; Kohl, Katrin

doi:10.1016/j.vaccine.2012.04.067

Cited by 55 publications

(45 citation statements)

References 46 publications

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“…The YF RT-qPCR protocol was standardized using a QuantiTect Virus ϩROX Vial kit (Qiagen), using 0.4 M each primer (YFallF and YFallR; Table 1 Two microliters of sample RNA was used in a final volume of 25 l. Each assay included a negative (nontemplate) control and standards in the range of 1 copy/reaction to 10 5 copies/reaction for ivRNA or 1 GE/reaction to 10 6 GE/reaction for the pDrive-5NC vector. The reactions were performed in 96-well plates or 8-tube strips and run on an ABI Prism 7500 real-time PCR system (Applied Biosystems).…”

Section: Methodsmentioning

confidence: 99%

Advanced Yellow Fever Virus Genome Detection in Point-of-Care Facilities and Reference Laboratories

et al. 2012

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Reported methods for the detection of the yellow fever viral genome are beset by limitations in sensitivity, specificity, strain detection spectra, and suitability to laboratories with simple infrastructure in areas of endemicity. We describe the development of two different approaches affording sensitive and specific detection of the yellow fever genome: a real-time reverse transcriptionquantitative PCR (RT-qPCR) and an isothermal protocol employing the same primer-probe set but based on helicase-dependent amplification technology (RT-tHDA). Both assays were evaluated using yellow fever cell culture supernatants as well as spiked and clinical samples. We demonstrate reliable detection by both assays of different strains of yellow fever virus with improved sensitivity and specificity. The RT-qPCR assay is a powerful tool for reference or diagnostic laboratories with real-time PCR capability, while the isothermal RT-tHDA assay represents a useful alternative to earlier amplification techniques for the molecular diagnosis of yellow fever by field or point-of-care laboratories.

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Section: Methodsmentioning

confidence: 99%

Advanced Yellow Fever Virus Genome Detection in Point-of-Care Facilities and Reference Laboratories

et al. 2012

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“…The Brighton definition correctly requires that besides RNA positivity in tissues, there should be characteristic histopathology (eg, liver midzonal necrosis, Councilman bodies) for confirmation of YEL-AVD. However, this definition includes positivity of viremias by RT-PCR 14 days after vaccination as one criterium for confirmation of YEL-AVD, 38 which could inflate this diagnosis.…”

Section: Viremia As a Determinant Of Serious Adverse Reactionsmentioning

confidence: 99%

Serious adverse events associated with yellow fever vaccine

Martins

Leal²,

Homma³

2015

Human Vaccines & Immunotherapeutics

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“…2 Another risk group is women in their prime child-bearing years. 6 Other suspected risk groups include infants and children 12 years of age, women between 39 and 49 years of age with systemic lupus erythematosus (SLE), and patients with Addison's disease or other autoimmune disorders 2,7 (Seligman SJ, unpublished data). This study was initiated to assist in the documentation of other risk groups.…”

Section: Introductionmentioning

confidence: 99%

Defining Risk Groups to Yellow Fever Vaccine-Associated Viscerotropic Disease in the Absence of Denominator Data

Seligman¹,

Cohen²,

Itan³

et al. 2014

The American Journal of Tropical Medicine and Hygiene

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Abstract. Several risk groups are known for the rare but serious, frequently fatal, viscerotropic reactions following live yellow fever virus vaccine (YEL-AVD). Establishing additional risk groups is hampered by ignorance of the numbers of vaccinees in factor-specific risk groups thus preventing their use as denominators in odds ratios (ORs). Here, we use an equation to calculate ORs using the prevalence of the factor-specific risk group in the population who remain well. The 95% confidence limits and P values can also be calculated. Moreover, if the estimate of the prevalence is imprecise, discrimination analysis can indicate the prevalence at which the confidence interval results in an OR of~1 revealing if the prevalence might be higher without yielding a non-significant result. These methods confirm some potential risk groups for YEL-AVD and cast doubt on another. They should prove useful in situations in which factor-specific risk group denominator data are not available.

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Viscerotropic disease: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

Cited by 55 publications

References 46 publications

Advanced Yellow Fever Virus Genome Detection in Point-of-Care Facilities and Reference Laboratories

Advanced Yellow Fever Virus Genome Detection in Point-of-Care Facilities and Reference Laboratories

Serious adverse events associated with yellow fever vaccine

Defining Risk Groups to Yellow Fever Vaccine-Associated Viscerotropic Disease in the Absence of Denominator Data

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