Study of the transmission of cytomegalovirus (CMV) infection from mother to foetus
Trial overview
Number of subjects with any CMV congenital infection
Timeframe: At Month 0
Number of subjects with CMV presence in the urine
Timeframe: Within 10 days post-delivery (Days 0-9)
Number of subjects with CMV presence in the amniotic fluid
Timeframe: Within 10 days post-delivery (Days 0-9)
Evidence of CMV DNA or CMV inclusions in tissues of an aborted or stillborn foetus
Timeframe: Within 10 days post-delivery (Days 0-9)
Number of CMV DNA copies in saliva, urine, blood or vaginal secretions
Timeframe: At Month 0
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)
Descriptive statistics of the anti-CMV Immunoglobulin type M (IgM) status
Timeframe: At Month 0
Descriptive statistics of the anti-CMV IgM status
Timeframe: At Month 2
Descriptive statistics of the anti-Cytomegalovirus (anti-CMV) Immunoglobulin type M (IgM) status
Timeframe: At Month 4
Anti-CMV Immunoglobulin type M (IgM) status, descriptive statistics
Timeframe: At Month 6
Descriptive statistics for the anti-CMV IgM status
Timeframe: 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
Timeframe: At Month 0
Anti-gB IgG antibody concentrations
Timeframe: 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
Timeframe: At Month 0
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)
CMV-specific cluster of differentiation 4 (CD4) T-cell frequencies
Timeframe: At Month 0
CMV-specific CD4 T-cell frequencies
Timeframe: 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
Timeframe: At Month 0
CMV-specific CD8 T-cell frequencies
Timeframe: 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
Timeframe: At Month 0
CMV-specific proliferating CD4 T cells frequencies
Timeframe: 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
Timeframe: At Day 0 = study entry
Anti-CMV tegument protein immunoglobulin G (IgG) antibody concentrations
Timeframe: At Month 2
Concentrations of anti-CMV tegument protein IgG antibodies
Timeframe: At Month 4
Anti-CMV tegument protein IgG antibody concentrations
Timeframe: At Month 6
Concentrations of anti-CMV IgG antibodies
Timeframe: 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
Timeframe: At Day 0 = study entry
Descriptive statistics of the anti-CMV tegument protein gB immunoglobulin G (IgG) avidity, by congenital infection status
Timeframe: At Month 2
Descriptive statistics of the anti-CMV tegument protein gB IgG avidity, by congenital infection status
Timeframe: At Month 4
Descriptive statistics of the anti-CMV tegument protein globulin type B (gB) IgG avidity, by congenital infection status
Timeframe: At Month 6
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)
Anti-CMV antibody titers, by neutralisation assay
Timeframe: From Month 0 to pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Participation 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.
- * 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.
- * 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.
- * 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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.