Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337955
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-23
Brief Title:
Non Primary HCMV Infection Natural History and Immune Response
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
Evolution of HCMV Non-primary Infection and Host Immune Response in HCMV-seropositive Mothers of Children Attending Day-care Centers An Observational Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of this observational study are i investigate the natural history of non-primary ie reactivation and reinfection HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response ii reliably distinguish between reactivation and reinfection
Prerequisite of the study is the availability of a maternal HCMV strain at baseline original strain to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation original strain or reinfection new strain
To increase the likelihood of exposure to different HCMV strains the study population is restricted to mothers of children attending day care centers
Prerequisite of the study is the availability of a maternal HCMV strain at baseline original strain to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation original strain or reinfection new strain
To increase the likelihood of exposure to different HCMV strains the study population is restricted to mothers of children attending day care centers
Detailed Description:
Eligible women will be identified and enrolled during pregnancy or at delivery Consenting mothers will be tested for HCMV DNA in saliva urine and vaginal swab at delivery andor at the first scheduled post-partum visit 2-4 months after delivery In addition mothers and children will be tested for presence of HCMV DNA in milk and saliva samples respectively
A mother-child pair is considered HCMV-DNA positive and therefore suitable for continuing the study ie the 12 months follow up after admission of the child to day care center whenever viral DNA is detected in clinical samples of either the mother or the child or both In fact when viral DNA is undetectable in the mother but is present in the saliva of a 2-4 month old infant it can be reasonably assumed that the strain is of maternal origin
The study does not require any modification in the normal mother-child relationship and participating mothers will be encouraged to behave normally However mothers will be asked to fill in a short questionnaire about basic behaviours in daily child care ie frequency of hand washing kissing of the infant sharing of food
The following clinical samples will be collected from mothers and infants at indicated times T
T0 Delivery
mother saliva urine vaginal swab peripheral blood
T1 2-4 months after delivery
mother saliva urine vaginal swab milk peripheral blood
infant saliva swab
T2 Admission of the infant to day care center
mother saliva swab urine vaginal swab peripheral blood
infant saliva swab
T3-T6 Every 3 months after admission of the infant for one year
mother saliva swab urine vaginal swab peripheral blood
infant saliva swab
Virological analyses
1 HCMV DNA detection and quantification in blood and body specimens
2 sequence analysis of selected variable viral genes and determination of strains diversity whole genome will also be sequenced when possible
3 HCMV isolation from collected specimens when HCMV DNA shedding is detected
Immunological analyses
antibody response
1 IgG and IgM to whole HCMV antigens
2 IgG to glycoprotein complexes gHgLpUL128L gHgLgO gB
3 neutralizing Nt Ab blocking infection of epithelialendothelial cells and fibroblasts
T cell response
1 ex vivo cytokine IFNgammaIL-2 production
2 ex vivo proliferation after stimulation with HCMV antigens
3 differentiation state of HCMV specific T cells CCR7 CD45RA IL7R expression
Questionnaire
Participating mothers will also be invited to fill in a questionnaire concerning their daily habits in terms of caring for their children
A mother-child pair is considered HCMV-DNA positive and therefore suitable for continuing the study ie the 12 months follow up after admission of the child to day care center whenever viral DNA is detected in clinical samples of either the mother or the child or both In fact when viral DNA is undetectable in the mother but is present in the saliva of a 2-4 month old infant it can be reasonably assumed that the strain is of maternal origin
The study does not require any modification in the normal mother-child relationship and participating mothers will be encouraged to behave normally However mothers will be asked to fill in a short questionnaire about basic behaviours in daily child care ie frequency of hand washing kissing of the infant sharing of food
The following clinical samples will be collected from mothers and infants at indicated times T
T0 Delivery
mother saliva urine vaginal swab peripheral blood
T1 2-4 months after delivery
mother saliva urine vaginal swab milk peripheral blood
infant saliva swab
T2 Admission of the infant to day care center
mother saliva swab urine vaginal swab peripheral blood
infant saliva swab
T3-T6 Every 3 months after admission of the infant for one year
mother saliva swab urine vaginal swab peripheral blood
infant saliva swab
Virological analyses
1 HCMV DNA detection and quantification in blood and body specimens
2 sequence analysis of selected variable viral genes and determination of strains diversity whole genome will also be sequenced when possible
3 HCMV isolation from collected specimens when HCMV DNA shedding is detected
Immunological analyses
antibody response
1 IgG and IgM to whole HCMV antigens
2 IgG to glycoprotein complexes gHgLpUL128L gHgLgO gB
3 neutralizing Nt Ab blocking infection of epithelialendothelial cells and fibroblasts
T cell response
1 ex vivo cytokine IFNgammaIL-2 production
2 ex vivo proliferation after stimulation with HCMV antigens
3 differentiation state of HCMV specific T cells CCR7 CD45RA IL7R expression
Questionnaire
Participating mothers will also be invited to fill in a questionnaire concerning their daily habits in terms of caring for their children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None