Cytomegalovirus InfectionsNCT06337955
Non Primary HCMV Infection: Natural History and Immune Response
An observational study of Cytomegalovirus Infections, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections
- How many people
- 204 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2017to Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Congenital or acquired immunodeficiency
- Immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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:
- HCMV DNA detection and quantification in blood and body specimens;
- sequence analysis of selected variable viral genes and determination of strain(s) diversity (whole genome will also be sequenced when possible);
- HCMV isolation from collected specimens (when HCMV DNA shedding is detected).
Immunological analyses:
- antibody response:
- IgG and IgM to whole HCMV antigens;
- IgG to glycoprotein complexes gHgLpUL128L, gHgLgO, gB;
- neutralizing (Nt) Ab blocking infection of epithelial/endothelial cells and fibroblasts.
- T cell response:
- ex vivo cytokine (IFNgamma/IL-2) production;
- ex vivo proliferation after stimulation with HCMV antigens;
- 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.
- Conditions
- Cytomegalovirus Infections
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Levels of IgG and IgM to whole HCMV antigens; titers of IgG specific for HCMV envelope glycoprotein complexes; neutralizing antibody titers; number, cytokine production and proliferation of T cells in response to HCMV.
Measured: 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
Data collected with the questionnaire and data on HCMV shedding by the own child will be compared between women with or without non-primary infections.
Measured: T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start6 Jun 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia, Merck Sharp & Dohme LLC, Fondazione Regionale per la Ricerca Biomedica
- Responsible party
- Principal investigator, Daniele Lilleri, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Daniele Lilleri, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337955
- Sponsor's protocol ID
- 20170007596
- Status last verified
- Nov 2024
- First submitted
- 23 Mar 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06337955
- Acronym / sponsor ID
- 20170007596
- Conditions
- Cytomegalovirus Infections
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- University of Pavia, Merck Sharp & Dohme LLC, Fondazione Regionale per la Ricerca Biomedica
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- HCMV DNA detection and quantification in blood and body specimens;
- sequence analysis of selected variable viral genes and determination of strain(s) diversity (whole genome will also be sequenced when possible);
- HCMV isolation from collected specimens (when HCMV DNA shedding is detected).
Immunological analyses:
- antibody response:
- IgG and IgM to whole HCMV antigens;
- IgG to glycoprotein complexes gHgLpUL128L, gHgLgO, gB;
- neutralizing (Nt) Ab blocking infection of epithelial/endothelial cells and fibroblasts.
- T cell response:
- ex vivo cytokine (IFNgamma/IL-2) production;
- ex vivo proliferation after stimulation with HCMV antigens;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Congenital or acquired immunodeficiency
- Immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCMV non-primary infection (reinfection or reactivation).
Time frame: 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.
2 secondary outcomes
HCMV-specific humoral and cell-mediated immune response during non-primary infection.
Time frame: 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
Time frame: T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Lilleri, MD principal investigator
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCMV non-primary infection (reinfection or reactivation). (time frame: T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.