Non Primary HCMV Infection: Natural History and Immune Response

NCT06337955 | Active Not Recruiting

• 1 other identifier: 20170007596
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

Other Outcomes (1)

• Potential use of saliva swabs for antibody determination.

  T0: Enrollment.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult (≥18 years of age) HCMV IgG-positive, breast feeding\* woman.
• Willingness to enroll the infant in a public or private day care facility with at least 5 attendees at ≤ 12 months of age.
• Willingness to participate in the study.
• In case of foreign origin, language skills sufficient to understand information material and give informed consent.
• Written informed consent. \* Breast feeding not required in case of availability of HCMV DNA-positive samples from the mother and/or fetus and/or newborn.

You may not qualify if:

• Congenital or acquired immunodeficiency
• Immunosuppressive therapy

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Università degli Studi di Pavia: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Fondazione Regionale per la Ricerca Biomedica: collaborator

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, peripheral blood mononuclear cells, saliva swab, vaginal swab, urine.

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Daniele Lilleri, MD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: June 6, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)