Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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.

Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Within 10 days post-delivery (Days 0-9)