Evolution of HCMV Non-primary Infection and Host Immune Response in HCMV-seropositive Mothers of Children Attending Day-care Centers: an Observational Prospective Study
Sponsor study identifier
observational
204
1 country
1
Study Start
June 6, 2017
Actual (reported)Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2017
Actual (reported)March 23, 2024
Actual (reported)March 29, 2024
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
HCMV non-primary infection (reinfection or reactivation).
HCMV non-primary infections will be calculated as the frequency of women with the presence of HCMV DNA in at least one of the body compartments examined (blood, saliva, urine, genital tract) at any time point. Reinfections will be considered non-primary infections in which the HCMV strain detected is different from the strain detected at baseline.
T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
HCMV-specific humoral and cell-mediated immune response during non-primary infection.
T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
Maternal behaviours and occurrence of non-primary infection
T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
Potential use of saliva swabs for antibody determination.
T0: Enrollment.
Study population will be identified among pregnant women admitted for delivery at Fondazione IRCCS Policlinico San Matteo. The great majority of these women are routinely tested for HCMV antibody either in the first trimester of gestation or at the time of pre-admission for delivery at around 36 week's gestation.
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100, Italy
Whole blood, serum, peripheral blood mononuclear cells, saliva swab, vaginal swab, urine.
Daniele Lilleri, MD
Fondazione IRCCS Policlinico San Matteo
204 participants (actual enrollment reported by the registry).
First Submitted
March 23, 2024
First Posted
March 29, 2024
Study Start
June 6, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 5, 2024
Record last verified: 2024-11
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