N/A
N=155
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Infections, Cytomegalovirus · Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT01251744 ↗Enrolled (actual)
155
Serious AEs
0.7%
Results posted
Jan 2020
Primary outcome: Primary: Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection — 24; 20; 4; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood sample (Procedure); Cord blood sample (Procedure); Saliva swab (Procedure); Urine sampling (Procedure); Vaginal swab (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection |
24; 20; 4; 58; 58; 0 | — |
| PRIMARY Number of Subjects With CMV Presence in the Urine |
6; 5; 5; 4; 19; 6 | — |
| PRIMARY Number of Subjects With CMV Presence in the Amniotic Fluid |
9; 7; 2; 6; 4; 2 | — |
| PRIMARY Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus |
— | — |
| PRIMARY Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions |
0.000; 0.000; 0.000; 1050.000; 1950.000 | — |
| PRIMARY Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions |
0.000; 0.000; 0.000; 311.000; 1950.000 | — |
| PRIMARY Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status |
53; 12; 4 | — |
| PRIMARY Descriptive Statistics of the Anti-CMV IgM Status |
27; 24; 5 | — |
| PRIMARY Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status |
8; 13; 2 | — |
| PRIMARY Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics |
1; 3 | — |
| PRIMARY Descriptive Statistics for the Anti-CMV IgM Status |
24; 35; 5 | — |
| PRIMARY Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations |
4460.8 | — |
| PRIMARY Anti-gB IgG Antibody Concentrations |
6708.2 | — |
| PRIMARY Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index |
22.000 | — |
| PRIMARY Descriptive Statistics of the Anti-gB IgG Avidity Index |
36.500 | — |
| PRIMARY CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies |
350.50; 1009.50; 2864.00; 510.00 | — |
| PRIMARY CMV-specific CD4 T-cell Frequencies |
261.00; 830.00; 2330.00; 455.00 | — |
| PRIMARY CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies |
1448.00; 274.00; 30.50; 1030.00 | — |
| PRIMARY CMV-specific CD8 T-cell Frequencies |
2519.00; 209.00; 34.50; 1054.00 | — |
| PRIMARY CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies |
-0.00; 0.61; 4.37; 0.07 | — |
| PRIMARY CMV-specific Proliferating CD4 T Cells Frequencies |
-0.04; 0.53; 4.02; 0.06 | — |
| PRIMARY Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies |
4.8 | — |
| PRIMARY Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations |
4.9 | — |
| PRIMARY Concentrations of Anti-CMV Tegument Protein IgG Antibodies |
4.9 | — |
| PRIMARY Anti-CMV Tegument Protein IgG Antibody Concentrations |
13.5 | — |
| PRIMARY Concentrations of Anti-CMV IgG Antibodies |
5.3 | — |
| PRIMARY Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status |
23.000 | — |
| PRIMARY Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status |
24.500 | — |
| PRIMARY Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status |
28.000 | — |
| PRIMARY Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status |
46.000 | — |
| PRIMARY Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status |
31.000 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast) |
583.9 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast) |
583.9 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast) |
583.9 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast) |
583.9 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast) |
583.9 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells) |
1100.2 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells) |
1100.2 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells) |
1100.2 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells) |
1100.2 | — |
| PRIMARY Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells) |
1100.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01251744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.