CMV Clinical Trial
— cCHIPSOfficial title:
An Observational, Longitudinal, Natural History, Feasibility Cohort Study to Evaluate the Characteristics of Cytomegalovirus (CMV) Shedding in CMV Seropositive Women Throughout Pregnancy
Verified date | July 2021 |
Source | St George's, University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The cCHIPS study is a feasibility study for larger scale multi-centre studies and is designed as a single-centre observational cohort, longitudinal, natural history study. The overarching aim of this study is to evaluate the feasibility of performing larger scale, multi-centre studies to evaluate the relationship between CMV shedding in pregnancy with congenital CMV (cCMV). There is no randomisation involved in this study and all participants will perform the same study procedures and receive treatment as usual. The primary (main) objective is to evaluate the prevalence (percentage of occurrence) of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy. The secondary objectives are to evaluate the quantity of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy, to compare the prevalence and quantity of CMV shedding in CMV seropositive women between different sources of shedding (saliva, urine or vaginal secretions) and different gestational stages, to identify risk factors for CMV shedding in CMV seropositive pregnant women, to evaluate the acceptability of the study procedures to the participating pregnant women, to evaluate the proportion of women approached who are recruited into the study and who are completing the study, and to evaluate the relationship between CMV specific cell mediated immunity (a type of immune protection following exposure to CMV) and CMV shedding in CMV seropositive pregnant women. The tertiary objective is to compare the evaluation of CMV specific T cell immune responses (a type of CMV specific cell mediated immunity) between the two commercially available CMV-specific T cell immune response assays which are QuantiFERON-CMV and CMV-ELISPOT assays. This study will aim to recruit 200 pregnant women. This study will be undertaken in parallel with a separate study called RACE-FIT (REC reference number 18/SC/0360, IRAS ID 239977), which will have ethical approval to screen pregnant women with children less than 4 years of age booked for their antenatal care at St George's Hospital, London, identified during the antenatal combined screening bloods appointment or the antenatal booking appointment, for their CMV serology status on a sample of blood collected as part of the screening process. As part of the ethical approval sought for the RACE-FIT study and the cCHIPS study, the pregnant women screened and found to be CMV seronegative will be eligible for recruitment into the RACE-FIT study and those screened and found to be CMV seropositive will be eligible and approached for recruitment into the cCHIPS study. The cCHIPS study aim to recruit over a 6 month period. The study involves four visits (Visit 1, Visit 2, Visit 3, Visit 4) for each participant. The total study period for each participant will be between 6 to 8 months.
Status | Active, not recruiting |
Enrollment | 162 |
Est. completion date | December 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant - CMV seropositive - Willing and able to provide informed consent - Living with child(ren), at least one of whom is less than four years old - Willing to have saliva, urine and vaginal secretion sampling to be tested for CMV PCR - Willing to be followed up until the postpartum period Exclusion Criteria: - Age less than 18 years - Evidence of acute maternal CMV infection at the time of screening - Documented immunodeficiency of any aetiology including the use of oral steroid therapy equivalent to >1mg/kg of prednisone per day for more than one week - In the opinion of the investigator is unlikely to comply with the study procedures - In the opinion of the investigator does not have adequate understanding or verbal and written English |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St George's University Hospitals NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London | St George's University Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prevalence of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy | The percentage of subjects with detectable CMV virus (detected via polymerase chain reaction) in any bodily fluid (saliva, urine or vaginal secretions) at any point in pregnancy | 20 months | |
Secondary | The quantity of CMV shedding in saliva, urine and vaginal secretions of CMV seropositive women throughout pregnancy | The quantity of detectable CMV virus (measured via quantitative polymerase chain reaction) in saliva, urine and vaginal secretions at individual study visits and cumulatively | 20 months | |
Secondary | The fold-differences in the prevalence of CMV shedding in saliva, urine and vaginal secretions in CMV seropositive women throughout pregnancy | The fold-differences in the percentage of subjects with detectable CMV virus (detected via polymerase chain reaction) between saliva, urine and vaginal secretions | 20 months | |
Secondary | The fold-differences in the prevalence of CMV shedding in saliva, urine and vaginal secretions between different gestational stages of pregnancy in CMV seropositive women | The fold-differences in the percentage of subjects with detectable CMV virus in saliva, urine and vaginal secretions (detected via polymerase chain reaction) between early in pregnancy, middle of pregnancy, and late in pregnancy, | 20 months | |
Secondary | The fold-differences in the quantity of CMV shedding in saliva, urine and vaginal secretions in CMV seropositive women throughout pregnancy | The fold-differences in the quantity of detectable CMV virus (measured via quantitative polymerase chain reaction) between saliva, urine and vaginal secretions | 20 months | |
Secondary | The fold-differences in the quantity of CMV shedding in saliva, urine and vaginal secretions between different gestational stages of pregnancy in CMV seropositive women | The fold-differences in the quantity of detectable CMV virus in saliva, urine and vaginal secretions (measured via quantitative polymerase chain reaction) between early in pregnancy, middle of pregnancy and late in pregnancy | 20 months | |
Secondary | The association of contact between pregnant women and their young children's urine and saliva with CMV shedding in CMV seropositive pregnant women | The association between CMV shedding and specific types of handling of child(ren)'s urine and saliva by the participants, as a binary outcome (detectable shedding versus no detectable shedding), will be investigated using multivariable mixed effects models, assessed using the contact questionnaire at all study visits (Visit 1, Visit 2, Visit 3 and Visit 4) | 20 months | |
Secondary | The acceptability of the study procedures to participating pregnant women | Acceptability of the study procedures to participants will be analysed descriptively. Any free text comments made through the feedback questionnaire completed by participants at the last visit will be summarised. | 20 months | |
Secondary | The proportion of women approached who are recruited into the study | The percentage of women approached who are recruited into the study | 20 months | |
Secondary | The proportion of participants completing the study | The percentage of participants who complete the study (provide urine, saliva and vaginal secretion samples and questionnaire data at all four study visits, with or without blood and newborn saliva samples) | 20 months | |
Secondary | The association between CMV-specific T cell immune response and CMV shedding in CMV seropositive pregnant women as measured by CMV-QuantiFERON | The percentage of reactive IFN-? in the plasma as measured by CMV-QuantiFERON assay when CMV shedding in saliva, urine or vaginal secretions occurs in the participant | 20 months | |
Secondary | The association between CMV-specific T cell immune response and CMV shedding in CMV seropositive pregnant women as measured by CMV-ELISPOT | The percentage of reactive IFN-? in the plasma as measured by CMV-ELISPOT assay when CMV shedding in saliva, urine or vaginal secretions occurs in the participant | 20 months |
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