Clinical trial NCT01251744: Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Official title: Study of Maternal-foetal Cytomegalovirus (CMV) Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Cytomegalovirus
Cytomegalovirus Infections
Keywords: Pregnancy
Congenital
Cytomegalovirus infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
timeFrame: At Month 0
measure: Number of Subjects With CMV Presence in the Urine
timeFrame: Within 10 days post-delivery (Days 0-9)
measure: Number of Subjects With CMV Presence in the Amniotic Fluid
timeFrame: Within 10 days post-delivery (Days 0-9)
measure: Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus
timeFrame: Within 10 days post-delivery (Days 0-9)
measure: Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
timeFrame: At Month 0
measure: Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
timeFrame: At Month 0
measure: Descriptive Statistics of the Anti-CMV IgM Status
timeFrame: At Month 2
measure: Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
timeFrame: At Month 4
measure: Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
timeFrame: At Month 6
measure: Descriptive Statistics for the Anti-CMV IgM Status
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
timeFrame: At Month 0
measure: Anti-gB IgG Antibody Concentrations
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
timeFrame: At Month 0
measure: Descriptive Statistics of the Anti-gB IgG Avidity Index
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
timeFrame: At Month 0
measure: CMV-specific CD4 T-cell Frequencies
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
timeFrame: At Month 0
measure: CMV-specific CD8 T-cell Frequencies
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
timeFrame: At Month 0
measure: CMV-specific Proliferating CD4 T Cells Frequencies
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
timeFrame: At Day 0 = study entry
measure: Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
timeFrame: At Month 2
measure: Concentrations of Anti-CMV Tegument Protein IgG Antibodies
timeFrame: At Month 4
measure: Anti-CMV Tegument Protein IgG Antibody Concentrations
timeFrame: At Month 6
measure: Concentrations of Anti-CMV IgG Antibodies
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
timeFrame: At Day 0 = study entry
measure: Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
timeFrame: At Month 2
measure: Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
timeFrame: At Month 4
measure: Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
timeFrame: At Month 6
measure: Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
timeFrame: At Month 0
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
timeFrame: At Month 2
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
timeFrame: At Month 4
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
timeFrame: At Month 6
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
timeFrame: At Month 0
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
timeFrame: At Month 2
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
timeFrame: At Month 4
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
timeFrame: At Month 6
measure: Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
timeFrame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Charleroi
country: Belgium
facility: GSK Investigational Site
city: La Louvière
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Mons
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.