Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06337955 |
| Other study ID # |
20170007596 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 6, 2017 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Foundation IRCCS San Matteo Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goals of this observational study are: i) investigate the natural history of non-primary
(i.e. 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.
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 and/or 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 (i.e. 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 (i.e. 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 strain(s)
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 epithelial/endothelial cells and
fibroblasts.
- T cell response:
1. ex vivo cytokine (IFNgamma/IL-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.
