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Completed

NCT Number: NCT01888471

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])

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.

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Key information

Conditions

Streptococcus Agalactiae

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Johannesburg, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Procedure

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.

Vaginal swab sample

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2013
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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