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Completed

NCT Number: NCT01251744

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

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.

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Key information

Conditions

Infections, Cytomegalovirus Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Blood sample

Procedure

Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

Cord blood sample

Procedure

Cord blood sample taken at the time of delivery.

Saliva swab

Procedure

Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

Urine sampling

Procedure

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

Procedure

Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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)

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Dec 2, 2010
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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