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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01251744
First received: November 30, 2010
Last updated: September 18, 2014
Last verified: September 2014

November 30, 2010
September 18, 2014
December 2010
November 2013   (final data collection date for primary outcome measure)
  • Occurrence of congenital CMV infection in newborns or foetuses of subjects who had a confirmed primary CMV infection during pregnancy. [ Time Frame: During pregnancy and at pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Evidence of CMV in saliva, urine, blood or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: From study entry to, and including, pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Assessment of antibody responses to CMV of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Assessment of the cell-mediated immune responses of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion. ] [ Designated as safety issue: No ]
  • Evidence of CMV in saliva, urine, blood or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every month (saliva, urine, vaginal secretions) and every two months (blood) from study entry to, and including (except for vaginal secretions), pregnancy conclusion. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01251744 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Study of Maternal-foetal CMV Transmission

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Infections, Cytomegalovirus
  • Procedure: Blood sample
    Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
  • Procedure: Cord blood sample
    Cord blood sample taken at the time of delivery.
  • Procedure: Saliva swab
    Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
  • Procedure: Urine sampling
    Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
  • Procedure: Vaginal swab
    Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
Experimental: Group A.
Not Applicable.
Interventions:
  • Procedure: Blood sample
  • Procedure: Cord blood sample
  • Procedure: Saliva swab
  • Procedure: Urine sampling
  • Procedure: Vaginal swab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
June 2015
November 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01251744
113134
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP