Non Primary HCMV Infection: Natural History and Immune Response

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• HCMV non-primary infection (reinfection or reactivation). — T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
  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.

Trial sites (1)

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