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This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women 16 to 35 years of age. Participants will receive blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and will be followed to approximately Month 36. The primary hypothesis of the study is that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.
The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.
Aim of the work - To identify the prevalence of CMV infection in patients with steroid-refractory ulcerative colitis. - To assess the clinical and endoscopic conditions in these patients.
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
The purpose of the study is to evaluate the feasibility of using CSJ148 to prevent congenital human cytomegalovirus (HCMV) in pregnant women with primary HCMV infection.
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of SNHL in infants with asymptomatic congenital CMV infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop sensorineural hearing loss (SNHL) by 6 months of life.
CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
Human cytomegalovirus (CMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially premature infants. CMV infection can result from materno-fetal transmission during pregnancy (congenital infection) or postnatal transmission. The prevalence of congenital CMV infection in the newborn is estimated to be between 0.1 and 0.5%. Among the newborns in utero infected by CMV, it is estimated that 10-15% will present symptoms at birth (hypoacousia / unilateral or bilateral deafness, microcephaly, chorioretinitis, psychomotor retardation, etc.) and 0.5% of them will die. 20% of infected infants, mainly symptomatic newborns, suffer permanent sequelae, mainly loss of hearing. Many asymptomatic children at birth will present hearing loss and other delayed neurological complications. A progressive neurosensory hearing loss may develop for 13-15% of asymptomatic newborns at birth. Deafness is bilateral in 50% of cases, severe in more than 50% of cases, and its occurrence is often delayed. The hearing loss has a significant impact on the future life of the child, mainly on language acquisition and school performance. A systematic CMV screening is not currently recommended at birth due to the frequency of asymptomatic forms, difficulty in fetal diagnosis and prognosis, lack of consensus for preventive and curative treatment of the infection. New treatments are being evaluated and encouraging results could revive the debate. PCR from urine is the gold standard for the diagnosis of CMV infection. Urine collection is not systematic in newborns and its realization can sometimes be difficult. On the other hand, in children at risk (hypotrophy, prematurity, infectious risks, fetal distress or respiratory distress at birth), gastric aspiration is systematically performed at birth to overcome obstruction of the upper aero-digestive tract, to prevent oesophageal atresia, to avoid inhalation by reflux and sometimes to make a bacteriological diagnosis. Our hypothesis is that this liquid could be used for the detection of CMV infection without adding any invasive action in newborns. Ultimately, gastric aspirate could allow for routine CMV screening in children at risk and thus allow for appropriate care by nursing staff.The occurrence of immediate or delayed sensory sequelae in these children would be then limited.
Donor and recipient CMV-serostatus is one of the risk factor for CMV infection in solid organ transplantation. Recipients with IgG positive anti-CMV are classified as low-risk patients since it is considered that patients also have specific cellular immunity against CMV. However, investigators group has published that around 25% of solid organ transplant candidates lack CMV-specific CD8+ T-cell response ("humoral/cellular mismatch") and they are at a higher risk of CMV replication after transplantation. The main goal of this study is to analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell transplantation (HSCT) CMV-seropositive donors on the CMV reactivation after HSCT in CMVseropositive recipients. Investigators will study not only the incidence of CMV reactivation but also the severity (duration and peak viral load), CMV disease and survival. CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related donors will be consecutively recruited from Reina Sofía Hospital (Córdoba) and Marqués de Valdecilla Hospital (Santander). Patients will be monitored during 12 months after HSCT. CMV-specific CD8+ T-cell response will be determined in their donors, using QuantiFERON-CMV assay, to know the frequency of humoral/cellular mismatch. Innate and adaptive immune reconstitution will be assessed by flow cytometry and experimental QuantiFERON Monitor assay. CMV-specific CD8+ T-cell reconstitution will be determined using QuantiFERON-CMV assay.
Cytomegalovirus (CMV) is the most common cause of congenital infection, with approximately 0.5% of pregnant women being infected during pregnancy. CMV transmission to the fetus occurs in about one third of women who are infected in first trimester. Babies infected before birth are at risk for serious neurological complications such as intellectual disability, seizures, deafness, and even death. Most couples facing a diagnosis of congenital cytomegalovirus infection in their unborn baby focus heavily on the predicted neurological outcome for their child. To date, methods to assess brain development in fetuses have been mainly limited to detecting structural brain abnormalities by ultrasound. However, these ultrasound signs may not become apparent until very late in pregnancy, and some neurological disability is not accompanied by any structural brain changes. More research on methods of predicting neurodevelopmental outcome independent of structural brain malformations before third trimester is urgently needed. The purpose of this study is to investigate a new method of studying the health of unborn babies using amniotic fluid. Amniocentesis is often performed after maternal CMV infection to diagnose fetal infection. Prior research by Dr Hui has demonstrated that cell free RNA in amniotic fluid can provide meaningful information from multiple organs including the fetal brain. The investigators propose to collect and analyse a small sample of amniotic fluid to detect which genes are turned "on" or "off" (gene expression) in a fetus that has a congenital CMV infection, compared to those without any infection. The genes that are differentially expressed in CMV infected fetuses will then be analysed to provide information on the broad physiological processes that are altered due to the infection ("functional analysis") and identify neurodevelopmental gene transcripts of interest for future studies ("biomarker discovery").