Infections, CytomegalovirusNCT01251744

Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

A study testing Blood sample, Cord blood sample and Saliva swab in people with Infections, Cytomegalovirus and Cytomegalovirus Infections, run by GlaxoSmithKline at 9 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Infections, Cytomegalovirus, Cytomegalovirus Infections
What is being tested?: Blood sample, Cord blood sample and Saliva swab
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 9 sitesBelgium
Study dates: 9 Dec 2010to 17 Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who the investigator believes that they can and will comply with the requirements of the protocol .
A pregnant female, 18 years of age or older at the time of study enrolment.
Women with confirmed primary CMV infection.
Written informed consent obtained from the subject.

Who cannot join

Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product.
Previous vaccination against CMV infection.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination
Major congenital defects, serious chronic illness or organ transplantation.
Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy.
Documented Human immunodeficiency virus (HIV)-positive subject.
Gestational age of more than 34 weeks, as determined by foetal ultrasound.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Belgium9 sites

GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1050
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Charleroi, 6000
GSK Investigational Site
La Louvière, 7100
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
GSK Investigational Site
Mons, 7000
GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

About this study

Official title: Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.

Conditions: Infections, Cytomegalovirus, Cytomegalovirus Infections
Being tested: Blood sample, Cord blood sample, Saliva swab, Urine sampling, Vaginal swab
Keywords: Pregnancy, Congenital, Cytomegalovirus infection
Medical subject headings: Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood sampleProcedure or surgery
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Cord blood sampleProcedure or surgery
Cord blood sample taken at the time of delivery.
Saliva swabProcedure or surgery
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Urine samplingProcedure or surgery
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Vaginal swabProcedure or surgery
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.

Study groups in NCT01251744
Study group	Role	What they receive
CMV Mothers' Group	Experimental	Pregnant subjects with confirmed primary CMV infection. Receives: Procedure: Blood sample; Procedure: Cord blood sample; Procedure: Saliva swab; Procedure: Urine sampling; Procedure: Vaginal swab
CMV Newborns' Group	Experimental	Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born. Receives: Procedure: Blood sample; Procedure: Cord blood sample; Procedure: Saliva swab; Procedure: Urine sampling; Procedure: Vaginal swab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
Measured: At Month 0
Number of Subjects With CMV Presence in the Urine
Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
Measured: Within 10 days post-delivery (Days 0-9)
Number of Subjects With CMV Presence in the Amniotic Fluid
Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
Measured: Within 10 days post-delivery (Days 0-9)
Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus
Measured: Within 10 days post-delivery (Days 0-9)
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine, blood and vaginal secretions every month from study entry to, and including, pregnancy conclusion.
Measured: At Month 0
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine and blood every month from study entry to, and including, pregnancy conclusion.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Measured: At Month 0
Descriptive Statistics of the Anti-CMV IgM Status
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Measured: At Month 2
Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Measured: At Month 4
Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.
Measured: At Month 6
Descriptive Statistics for the Anti-CMV IgM Status
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
Measured: At Month 0
Anti-gB IgG Antibody Concentrations
Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Measured: At Month 0
Descriptive Statistics of the Anti-gB IgG Avidity Index
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among: cluster of differentiation 40 ligand (CD40L), interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among Human Cytomegalovirus [HCMV] immediate-early gene [IE1] antigen, HCMV glicoprotein B [gB] antigen, HCMV lysate antigen and HCMV pp65 antigen).
Measured: At Month 0
CMV-specific CD4 T-cell Frequencies
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Measured: At Month 0
CMV-specific CD8 T-cell Frequencies
Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Measured: At Month 0
CMV-specific Proliferating CD4 T Cells Frequencies
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Note: Results were retrieved by subtracting the background without imputing the negative and zero values, this generated negative values.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Measured: At Day 0 = study entry
Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Measured: At Month 2
Concentrations of Anti-CMV Tegument Protein IgG Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Measured: At Month 4
Anti-CMV Tegument Protein IgG Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Measured: At Month 6
Concentrations of Anti-CMV IgG Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Measured: At Day 0 = study entry
Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Measured: At Month 2
Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Measured: At Month 4
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Measured: At Month 6
Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Measured: At Month 0
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Measured: At Month 2
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Measured: At Month 4
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Measured: At Month 6
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Measured: At Month 0
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Measured: At Month 2
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Measured: At Month 4
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Measured: At Month 6
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Measured: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 201017 Jun 2015

First posted2 Dec 2010 (estimated)
Study start9 Dec 2010
Primary completion6 Nov 2013
Study completion17 Jun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infections, CytomegalovirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01251744
Sponsor's protocol ID: 113134
Status last verified: May 2020
First submitted: 30 Nov 2010
Last updated: 29 Jun 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

Marchant A, Adali S, Alsdurf H, Bol V, Capelle X, De Schrevel N, Delroisse JM, Devlieger R, Dieussaert I, Donner C, Janssens M, Loquet P, Panackal AA, Seidl C, van den Berg RA, Paris R. Establishing Correlates of Maternal-Fetal Cytomegalovirus Transmission-One Step Closer Through Predictive Modeling. J Infect Dis. 2024 Dec 16;230(6):e1274-e1286. doi: 10.1093/infdis/jiae281.
PubMed 38865084
Antoine P, Olislagers V, Huygens A, Lecomte S, Liesnard C, Donner C, Marchant A. Functional exhaustion of CD4+ T lymphocytes during primary cytomegalovirus infection. J Immunol. 2012 Sep 1;189(5):2665-72. doi: 10.4049/jimmunol.1101165. Epub 2012 Aug 3.
PubMed 22865914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Maternal-foetal Cytomegalovirus (CMV) Transmission
ClinicalTrials.gov ID: NCT01251744
Acronym / sponsor ID: 113134
Conditions: Infections, Cytomegalovirus, Cytomegalovirus Infections
Keywords: Pregnancy, Congenital, Cytomegalovirus infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Dec 2010 (actual)
Primary completion: 6 Nov 2013 (actual)
Study completion: 17 Jun 2015 (actual)
First posted: 2 Dec 2010 (estimated)
Results: Posted 2 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CMV Mothers' Group	Experimental	Procedure: Blood sample, Procedure: Cord blood sample, Procedure: Saliva swab, Procedure: Urine sampling, Procedure: Vaginal swabPregnant subjects with confirmed primary CMV infection.
CMV Newborns' Group	Experimental	Procedure: Blood sample, Procedure: Cord blood sample, Procedure: Saliva swab, Procedure: Urine sampling, Procedure: Vaginal swabOffsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol .
A pregnant female, 18 years of age or older at the time of study enrolment.
Women with confirmed primary CMV infection.
Written informed consent obtained from the subject.

Key exclusion criteria (8 listed)

Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product.
Previous vaccination against CMV infection.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination
Major congenital defects, serious chronic illness or organ transplantation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood sampleBlood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.	Procedure or surgery	CMV Mothers' Group, CMV Newborns' Group
Cord blood sampleCord blood sample taken at the time of delivery.	Procedure or surgery	CMV Mothers' Group, CMV Newborns' Group
Saliva swabSaliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.	Procedure or surgery	CMV Mothers' Group, CMV Newborns' Group
Urine samplingApproximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.	Procedure or surgery	CMV Mothers' Group, CMV Newborns' Group
Vaginal swabVaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.	Procedure or surgery	CMV Mothers' Group, CMV Newborns' Group

Primary outcome

Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
Time frame: At Month 0
The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
Number of Subjects With CMV Presence in the Urine
Time frame: Within 10 days post-delivery (Days 0-9)
Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
Number of Subjects With CMV Presence in the Amniotic Fluid
Time frame: Within 10 days post-delivery (Days 0-9)
Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus
Time frame: Within 10 days post-delivery (Days 0-9)
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Time frame: At Month 0
The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine, blood and vaginal secretions every month from study entry to, and including, pregnancy conclusion.
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine and blood every month from study entry to, and including, pregnancy conclusion.
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Time frame: At Month 0
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Descriptive Statistics of the Anti-CMV IgM Status
Time frame: At Month 2
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Time frame: At Month 4
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Time frame: At Month 6
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.
Descriptive Statistics for the Anti-CMV IgM Status
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
Time frame: At Month 0
Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
Anti-gB IgG Antibody Concentrations
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
Time frame: At Month 0
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-gB IgG Avidity Index
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
Time frame: At Month 0
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among: cluster of differentiation 40 ligand (CD40L), interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among Human Cytomegalovirus [HCMV] immediate-early gene [IE1] antigen, HCMV glicoprotein B [gB] antigen, HCMV lysate antigen and HCMV pp65 antigen).
CMV-specific CD4 T-cell Frequencies
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
Time frame: At Month 0
Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
CMV-specific CD8 T-cell Frequencies
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
Time frame: At Month 0
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
CMV-specific Proliferating CD4 T Cells Frequencies
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen). Note: Results were retrieved by subtracting the background without imputing the negative and zero values, this generated negative values.
Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
Time frame: At Day 0 = study entry
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
Time frame: At Month 2
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Concentrations of Anti-CMV Tegument Protein IgG Antibodies
Time frame: At Month 4
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Anti-CMV Tegument Protein IgG Antibody Concentrations
Time frame: At Month 6
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Concentrations of Anti-CMV IgG Antibodies
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Time frame: At Day 0 = study entry
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Time frame: At Month 2
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
Time frame: At Month 4
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
Time frame: At Month 6
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time frame: At Month 0
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time frame: At Month 2
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time frame: At Month 4
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time frame: At Month 6
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time frame: At Month 0
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time frame: At Month 2
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time frame: At Month 4
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time frame: At Month 6
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.

Results and safety

Results posted to the registry on 2 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CMV Mothers' Group	77	76
CMV Newborns' Group	78	78

Primary outcome: Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection

Time frame: At Month 0. Count of participants. Unit: Participants

Measure	CMV Offsprings' Group n = 82	CMV Newborns' Group n = 78	CMV Foetus Group n = 4
Confirmed CMV infection	24	20	4
Not confirmed CMV infection	58	58	0

Population analysed: The analysis was performed on the Total Enrolled cohort of Infant subjects, which included the newborns' group diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years and foetus group, referring to infants that were stillborn or with pregnancy termination.

Primary outcome: Number of Subjects With CMV Presence in the Urine

Time frame: Within 10 days post-delivery (Days 0-9). Count of participants. Unit: Participants

Measure	CMV Newborns' Group n = 78
Positive: PCR Not Done/Culture Positive	6
Positive: PCR Positive/Culture Negative	5
Positive: PCR Positive/Culture Not Done	5
Positive: PCR Positive/Culture Positive	4
Negative: PCR Negative/Culture Negative	19
Negative: PCR Negative/Culture Not Done	6
Negative: PCR Not Done/Culture Negative	32
Not Done: PCR Not Done/Culture Not Done	1

Population analysed: The analysis was performed on the newborn sub-group in the Total Enrolled cohort of Infant subjects, which included the subjects diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years.

Primary outcome: Number of Subjects With CMV Presence in the Amniotic Fluid

Time frame: Within 10 days post-delivery (Days 0-9). Count of participants. Unit: Participants

Measure	CMV Infant Group n = 82	CMV Newborn Sub-Group n = 78	CMV Foetus Sub-Group n = 4
Positive: PCR Positive/Culture Negative	9	7	2
Positive: PCR Positive/Culture Positive	6	4	2
Negative: PCR Negative/Culture Negative	28	28	0
Negative: PCR Negative/Culture Not Done	9	9	0
Not Done: PCR Not Done/Culture Not Done	30	30	0

Population analysed: The analysis was performed on the Total Enrolled cohort of Infant subjects, which included the newborns sub-group diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years and foetus sub-group, referring to infants that were stillborn or with pregnancy termination.

Primary outcome: Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus

Time frame: Within 10 days post-delivery (Days 0-9)

Population analysed: The diagnosis of CMV in the newborn was done according to the local standard of care and samples were not collected for this analysis.

Adverse events

Time frame: Serious adverse events were reported during the entire study period (From Day 0 to pregnancy conclusion).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CMV Mothers' Group	0 of 77 (0%)	0 of 0	0 of 77
CMV Newborns' Group	1 of 78 (1.3%)	0 of 0	1 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38865084Marchant A, Adali S, Alsdurf H, Bol V, Capelle X, De Schrevel N, Delroisse JM, Devlieger R, Dieussaert I, Donner C, Janssens M, Loquet P, Panackal AA, Seidl C, van den Berg RA, Paris R. Establishing Correlates of Maternal-Fetal Cytomegalovirus Transmission-One Step Closer Through Predictive Modeling. J Infect Dis. 2024 Dec 16;230(6):e1274-e1286. doi: 10.1093/infdis/jiae281.
Derived from this study: PubMed 22865914Antoine P, Olislagers V, Huygens A, Lecomte S, Liesnard C, Donner C, Marchant A. Functional exhaustion of CD4+ T lymphocytes during primary cytomegalovirus infection. J Immunol. 2012 Sep 1;189(5):2665-72. doi: 10.4049/jimmunol.1101165. Epub 2012 Aug 3.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample, Cord blood sample and Saliva swab in people with Infections, Cytomegalovirus and Cytomegalovirus Infections, run by GlaxoSmithKline at 9 sites in Belgium.

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 4 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Belgium. 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?

Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection (time frame: At Month 0). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01251744, which also lists 2 linked publications.

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 29 Jun 2020.