A systematic literature review of the economic and healthcare resource burden of cytomegalovirus

Diaz-Decaro, John; Myers, Evan R.; Mucha, Jacek; Neumann, Monika; Lewandowski, Witold; Kaczanowska, Magdalena; Schmidt, Elvira; Natenshon, Andrew; Talarico, Carla; Buck, Philip O.

doi:10.1080/03007995.2023.2222583

Cited by 4 publications

(2 citation statements)

References 45 publications

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“…Human cytomegalovirus (CMV) is the most common congenital viral infection and a leading cause of sensorineural hearing loss and neurodevelopmental disability in children 1 . Worldwide, congenital CMV (cCMV) causes not only long‐term suffering in affected families, but also imposes a substantial economic burden on health and social care systems 2 . In pregnant women, CMV shedding in bodily fluids is associated with miscarriages and vertical transmission 3–7 …”

Section: Introductionmentioning

confidence: 99%

“…1 Worldwide, congenital CMV (cCMV) causes not only long-term suffering in affected families, but also imposes a substantial economic burden on health and social care systems. 2 In pregnant women, CMV shedding in bodily fluids is associated with miscarriages and vertical transmission. [3][4][5][6][7] Rapid laboratory testing for CMV in neonatal urine and saliva is recommended to diagnose cCMV and guide clinical management.…”

Section: Introductionmentioning

confidence: 99%

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Performance evaluation of fully automated cobas® 6800 CMV PCR for the detection and quantification of cytomegalovirus DNA in neonatal urine and saliva, and adult urine, saliva, and vaginal secretion

Tan,

Pope,

Carrington

2023

Journal of Medical Virology

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Laboratory testing for cytomegalovirus (CMV) in bodily fluids is essential to manage congenital and prenatal CMV infection. The rapid and fully automated cobas® CMV PCR is approved only for the testing of plasma in transplant patients. To evaluate the performance of the cobas® CMV to detect and quantify CMV DNA in neonatal and adult female urine, saliva, and vaginal secretion, the limit of detection (LoD), limit of quantification (LoQ), imprecision, linearity, PCR efficiency, bias, analytical specificity, cross‐reactivity, and cross‐contamination of the cobas® CMV for urine, saliva, and vaginal secretion was determined. The performance of the assay was evaluated prospectively with two laboratory‐developed PCR assays using neonatal and adult urine, saliva swabs, and vaginal swabs. The LoD and LoQ were 31 and 100 IU/mL, respectively, for urine, and 81 and 100 IU/mL, respectively, for vaginal secretion. The LoD and LoQ for saliva were the same (200 IU/mL). The cobas® CMV was precise (coefficient of variation ≤10%), linear (R2 ≥ 0.995), and efficient (1.07 and 1.09) between 100 and 250,000 IU/mL for the sample types. The bias and analytical specificity was <±0.30 log10 IU/mL and 100%, respectively. Cross‐reactivity with non‐CMV pathogens was not detected. Cross‐contamination rate was 0.28%. The diagnostic accuracy, sensitivity, and specificity of the cobas® CMV for neonatal urine and saliva were ≥95.0%, ≥93.3%, and ≥90.4%, respectively. The overall percent agreement for adult urine, saliva, and vaginal secretion was 86.6%, 94.5%, and 89.4%, respectively. Taken together, the cobas® CMV demonstrated acceptable analytical and diagnostic performance, and is suitable for routine diagnostic laboratory investigation of CMV infection in neonates and adults.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance evaluation of fully automated cobas® 6800 CMV PCR for the detection and quantification of cytomegalovirus DNA in neonatal urine and saliva, and adult urine, saliva, and vaginal secretion

Tan,

Pope,

Carrington

2023

Journal of Medical Virology

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Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults

Wu,

Hou,

Makrinos

et al. 2024

J Virol

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mRNA-1647 is an investigational mRNA-based vaccine against cytomegalovirus (CMV) that contains sequences encoding the CMV proteins glycoprotein B and pentamer. Humoral and cellular immune responses were evaluated in blood samples collected from healthy CMV-seropositive and CMV-seronegative adults who participated in a phase 1 trial of a three-dose series of mRNA-1647 (NCT03382405). Neutralizing antibody (nAb) titers against fibroblast and epithelial cell infection in sera from CMV-seronegative mRNA-1647 recipients were higher than those in sera from control CMV-seropositive samples and remained elevated up to 12 months after dose 3. nAb responses elicited by mRNA-1647 were comparable across 14 human CMV (HCMV) strains. Frequencies of antigen-specific memory B cells increased in CMV-seropositive and CMV-seronegative participants after each mRNA-1647 dose and remained elevated for up to 6 months after dose 3. mRNA-1647 elicited robust increases in frequencies and polyfunctionality of CD4 + T helper type 1 and effector CD8 + T cells in samples from CMV-seronegative and CMV-seropositive participants after stimulation with HCMV-specific peptides. The administration of three doses of mRNA-1647 to healthy adults elicited high nAb titers with wide-breadth, long-lasting memory B cells, and strong polyfunctional T-cell responses. These findings support further clinical development of the mRNA-1647 vaccine against CMV. IMPORTANCE Cytomegalovirus (CMV), a common virus that can infect people of all ages, may lead to serious health problems in unborn babies and those with a weakened immune system. Currently, there is no approved vaccine available to prevent CMV infection; however, the investigational messenger RNA (mRNA)–based CMV vaccine, mRNA-1647, is undergoing evaluation in clinical trials. The current analysis examined samples from a phase 1 trial of mRNA-1647 in healthy adults to better understand how the immune system reacts to vaccination. Three doses of mRNA-1647 produced a long-lasting immune response, thus supporting further investigation of the vaccine in the prevention of CMV infection. CLINICAL TRIALS Registered at ClinicalTrials.gov ( NCT03382405 ).

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Оновлені Узагальнені Рекомендації З Лікування Герпесвірусних Інфекцій Людини

Мальцев

2023

Immun. and Allerg.: Sci. and Pract.

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Дана робота є узагальненням і систематизацією накопичених дотепер наукових доказів ефективності застосування різних лікувальних втручань при герпесвірусних інфекціях людини в клінічній практиці. Представлені наукові рекомендації розглядають лікування інфекцій, викликаних герпес- вірусними агентами, як складний комплексний процес з врахуванням виду вірусу і чутливості конкретного штаму до противірусних ліків, нейро- або лімфотропості вірусу, поточної форми герпесвірусної інфекції, стану імунітету організму хазяїна зі з’ясуванням форми і структури імуносупресії, перебігу інфекції, важкості стану хворого, наявності ускладнень та досвіду попереднього лікування. Розглянута доказова база різних ациклічних аналогів нуклеозидів, аденіну арабінозиду, артесунату та різноманітних імунотерапевтичних інтервенцій, призначених з метою лікування або профілактики герпесвіруснних інфекцій. Підкреслено багатокомпонентність, мультидисциплінарність і персоніфікацію раціонального терапевтичного підходу при клінічному веденні пацієнтів з герпесвірусними ураженнями. Розглянуто роль і місце різних медичних спеціалістів в роботі мультидисциплінарних робочих груп. Дані рекомендації будуть корисними для лікарів різних спеціальностей з огляду на безпрецедентний пантропізм герпесвірусних агентів людини.

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A systematic literature review of the economic and healthcare resource burden of cytomegalovirus

Cited by 4 publications

References 45 publications

Performance evaluation of fully automated cobas® 6800 CMV PCR for the detection and quantification of cytomegalovirus DNA in neonatal urine and saliva, and adult urine, saliva, and vaginal secretion

Performance evaluation of fully automated cobas® 6800 CMV PCR for the detection and quantification of cytomegalovirus DNA in neonatal urine and saliva, and adult urine, saliva, and vaginal secretion

Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults

Оновлені Узагальнені Рекомендації З Лікування Герпесвірусних Інфекцій Людини

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