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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
160
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Cord blood sample taken at the time of delivery.
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
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 swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Charleroi, Belgium
GSK Investigational Site
La Louvière, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Liège, Belgium
GSK Investigational Site
Mons, Belgium
GSK Investigational Site
Wilrijk, Belgium
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.
Time frame: 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).
Time frame: 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).
Time frame: Within 10 days post-delivery (Days 0-9)
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
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