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Feasibility Study for Identifying Anti Capsular Antibody Protection Against Invasive Group B Streptococcus (GBS) Disease in Newborns of 0-6 Days Age (Early Onset Disease [EOD]) as Well as Among Infants of 7-90 Days Age (Late Onset Disease [LOD])

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ClinicalTrials.gov Identifier: NCT01888471
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age as well as infants of age less than 90 days age.

Condition or disease Intervention/treatment Phase
Streptococcus Agalactiae Procedure: Blood sample Other: Vaginal swab sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3033 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility Study for Identifying a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less ≤90 Days
Actual Study Start Date : December 11, 2013
Actual Primary Completion Date : July 14, 2014
Actual Study Completion Date : July 14, 2014

Arm Intervention/treatment
Cases Group

Cases Group will be defined as:

Maternal subjects identified with invasive GBS disease from the enrolled maternal-newborn dyad Study cohort: Cases will be classified as follows:

  • EOD (Early onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 0-6 days of birth.
  • LOD (Late onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 7-90 days of birth.
Procedure: Blood sample
Blood sample will be obtained from enrolled mothers at delivery(either immediately before or after delivery) Both original blood sample and cord blood sample will be obtained for serology.

Other: Vaginal swab sample
Vaginal swab will be collected at delivery from a pre-defined subset of enrolled mothers for the identification of controls, for determining GBS maternal colonization status and serotype.

Controls Group
Controls will be defined as newborns to mothers, enrolled into the study and identified as colonized by a serotype which is homologous to that of cases, but who do not develop invasive GBS disease.
Procedure: Blood sample
Blood sample will be obtained from enrolled mothers at delivery(either immediately before or after delivery) Both original blood sample and cord blood sample will be obtained for serology.

Other: Vaginal swab sample
Vaginal swab will be collected at delivery from a pre-defined subset of enrolled mothers for the identification of controls, for determining GBS maternal colonization status and serotype.




Primary Outcome Measures :
  1. Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened. [ Time Frame: During routine antenatal visits in the 4 months enrollment period (in antenatal clinics attached to study delivery units or the clinics serving the population delivering at those unit) ]

    Maternal mothers were excluded at screening if:

    • Age <18 yrs.
    • Not planning to deliver at study center.
    • Did not consent.

  2. Proportion (percentage) of maternal subjects enrolled in ante-natal clinics. [ Time Frame: During routine antenatal visits in the 4 months enrollment period(in antenatal clinics attached to study delivery units) ]
    Percentage of maternal mothers who were not excluded at screening and who were presenting in antenatal clinics.

  3. Proportion (percentage) of maternal subjects enrolled at delivery. [ Time Frame: At delivery ]
    Percentage of maternal mothers who were not excluded at screening and who were enrolled at delivery visit.

  4. Proportion (percentage) of mother-infant dyads enrolled with data available to assess early censorship criteria. [ Time Frame: At delivery ]

    Percentage of mothers who were not excluded at screening and with data available to assess Early censoring criteria for defining the final analysis population:

    • Intravenous intrapartum antibiotics at delivery.
    • Blood transfusion in the 30 days prior to delivery.
    • Infant born with life threatening condition/ congenital malformation.
    • Failure to complete 90 day Follow-Up for potential controls.
    • Non-homologous serotype in case infants and mothers.

  5. Proportion (percentage) of enrolled mother-infant dyads with cord blood collected. [ Time Frame: At delivery ]
    Percentage of maternal mother (who were not excluded at screening) -infants dyads and with cord blood sample obtained for serology.

  6. Proportion (percentage) of enrolled mother-infant dyads with both maternal and cord blood collected. [ Time Frame: At delivery ]
    Percentage of maternal mother (who were not excluded at screening) -infants dyads and with both maternal and cord blood sample obtained for serology.

  7. Proportion (percentage) of mother-infant dyads with complete data on the defined key clinical variables. [ Time Frame: Throughout the study, an average of 4 months. ]

    Percentage of maternal mother (who were not excluded at screening) -infants dyads with defined key clinical variables.

    The key clinical variables have been defined as follows:

    Maternal subjects

    • Smoking during pregnancy,
    • Vaginal douche during pregnancy,
    • Gestational age at enrolment,
    • HIV test completed during routine care,
    • For those with test completed availability of test result and for HIV positive subjects CD4 count and viral load data.
    • Time between rupture of membranes and delivery,
    • Intrapartum antibiotic usage at delivery and duration of treatment
    • Evidence of intra-amniotic uterine infection.

    Infant subjects:

    • Birth weight,
    • Head circumference,
    • Congenital malformation,
    • Completion of 90-day follow-up visit in subset of sub-jects (cases and controls) eligible for this visit.

  8. Percentage of subjects who completed the 90-day follow up visit in subset of subjects eligible for this visit. [ Time Frame: At 90 day follow up visit ]
  9. Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS. [ Time Frame: Throughout the study, an average of 4 months. ]
  10. Percentage of maternal subjects who had culture positive for GBS, classified by serotype. [ Time Frame: Throughout the study, an average of 4 months. ]
  11. GBS anti-capsular antibody concentration (serotype-specific anti capsular antibody) in maternal subjects, vaginally colonized with GBS. [ Time Frame: At delivery ]
  12. GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects. [ Time Frame: At birth ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women (irrespective of gestational age staging or underlying comorbidities) attending for antenatal care at CHBAH or an allied antenatal clinic and/or delivering at the participating delivery center (CHBAH).
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women (irrespective of gestational age staging or underlying comorbidities) attending for antenatal care at Chris Hani Baragwanath Academic Hospital (CHBAH) or an allied antenatal clinic and/or delivering at the participating delivery center (CHBAH)
  • Subjects aged ≥18 years.
  • Able to understand and comply with planned study procedures.
  • Provides written informed consent.

Exclusion Criteria:

• Subjects Refusing to consent to study participation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888471


Locations
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South Africa
GSK Investigational Site
Johannesburg, South Africa
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01888471    
Other Study ID Numbers: 205523
V98_22OB ( Other Identifier: Novartis )
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by GlaxoSmithKline:
Streptococcal disease
Feasibility
Infants