Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus - Full Text View

Purpose

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.

Condition	Intervention
Infections, Cytomegalovirus	Procedure: Blood sample Procedure: Cord blood sample Procedure: Saliva swab Procedure: Urine sampling Procedure: Vaginal swab


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

Resource links provided by NLM:

MedlinePlus related topics: Cytomegalovirus Infections Urine and Urination

Genetic and Rare Diseases Information Center resources: Cytomegalic Inclusion Disease

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of congenital CMV infection in newborns or foetuses of subjects who had a confirmed primary CMV infection during pregnancy. [ Time Frame: From pregnancy start to its conclusion (participants will be followed for the duration of their pregnancy, an expected average of 9 months) ] [ 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 start (Day 0) to, and including, pregnancy conclusion (participants will be followed for the duration of their pregnancy, an expected average of 9 months) ] [ 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: From study start (Day 0) to, and including, pregnancy conclusion (participants will be followed for the duration of their pregnancy, an expected average of 9 months) ] [ 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: From study start (Day 0) to, and including, pregnancy conclusion (participants will be followed for the duration of their pregnancy, an expected average of 9 months) ] [ Designated as safety issue: No ]
Evidence of CMV in saliva, urine or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: From study start (Day 0) to, and including, pregnancy conclusion (participants will be followed for the duration of their pregnancy, an expected average of 9 months) ] [ Designated as safety issue: No ]
Evidence of CMV in blood of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: From study start (Day 0) to, and including, pregnancy conclusion (participants will be followed for the duration of their pregnancy, an expected average of 9 months) ] [ Designated as safety issue: No ]


Enrollment:	159
Study Start Date:	December 2010
Study Completion Date:	June 2015
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A.	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.

Arms

Assigned Interventions

Experimental: Group A.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251744

Locations


Belgium
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Bruxelles, Belgium, 1050
GSK Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Charleroi, Belgium, 6000
GSK Investigational Site
La Louvière, Belgium, 7100
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Mons, Belgium, 7000
GSK Investigational Site
Wilrijk, Belgium, 2610

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01251744 History of Changes
Other Study ID Numbers:	113134
Study First Received:	November 30, 2010
Last Updated:	September 24, 2015
Health Authority:	Belgium: Agence Fédérale des Médicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:


Cytomegalovirus infection Congenital Pregnancy

Additional relevant MeSH terms:


Infection Communicable Diseases Cytomegalovirus Infections	Herpesviridae Infections DNA Virus Infections Virus Diseases

ClinicalTrials.gov processed this record on September 23, 2016