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Streptococcus AgalactiaeNCT01888471

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])

A study testing Blood sample and Vaginal swab sample in people with Streptococcus Agalactiae, run by GlaxoSmithKline at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Streptococcus Agalactiae
What is being tested?
Blood sample and Vaginal swab sample
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,033 participants
Where
1 siteSouth Africa
Study dates
11 Dec 2013to 14 Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Subjects Refusing to consent to study participation.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • GSK Investigational Site

    Johannesburg

Other trials in South Africa

About this study

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

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.

Being tested
Blood sample, Vaginal swab sample
Keywords
Streptococcal disease, Feasibility, Infants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleProcedure or surgery

    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 sampleOther

    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.

Study groups in NCT01888471
Study groupRoleWhat they receive
Cases GroupOtherCases 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.
Receives: Procedure: Blood sample; Other: Vaginal swab sample
Controls GroupOtherControls 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.
Receives: Procedure: Blood sample; Other: Vaginal swab sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened.

    Maternal mothers were excluded at screening if:

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

    Measured: 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)

  2. Proportion (percentage) of maternal subjects enrolled in ante-natal clinics.

    Percentage of maternal mothers who were not excluded at screening and who were presenting in antenatal clinics.

    Measured: During routine antenatal visits in the 4 months enrollment period(in antenatal clinics attached to study delivery units)

  3. Proportion (percentage) of maternal subjects enrolled at delivery.

    Percentage of maternal mothers who were not excluded at screening and who were enrolled at delivery visit.

    Measured: At delivery

  4. Proportion (percentage) of mother-infant dyads enrolled with data available to assess early censorship criteria.

    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.

    Measured: At delivery

  5. Proportion (percentage) of enrolled mother-infant dyads with cord blood collected.

    Percentage of maternal mother (who were not excluded at screening) -infants dyads and with cord blood sample obtained for serology.

    Measured: At delivery

  6. Proportion (percentage) of enrolled mother-infant dyads with both maternal and cord blood collected.

    Percentage of maternal mother (who were not excluded at screening) -infants dyads and with both maternal and cord blood sample obtained for serology.

    Measured: At delivery

  7. Proportion (percentage) of mother-infant dyads with complete data on the defined key clinical variables.

    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.

    Measured: Throughout the study, an average of 4 months.

  8. Percentage of subjects who completed the 90-day follow up visit in subset of subjects eligible for this visit.

    Measured: At 90 day follow up visit

  9. Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS.

    Measured: Throughout the study, an average of 4 months.

  10. Percentage of maternal subjects who had culture positive for GBS, classified by serotype.

    Measured: 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.

    Measured: At delivery

  12. GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects.

    Measured: At birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2013 (estimated)
  2. Study start11 Dec 2013
  3. Primary completion14 Jul 2014
  4. Study completion14 Jul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3,033 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01888471
Sponsor's protocol ID
205523
Other IDs
V98_22OB
Status last verified
Jul 2019
First submitted
25 Jun 2013
Last updated
19 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.

    PubMed 26409812

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample and Vaginal swab sample in people with Streptococcus Agalactiae, run by GlaxoSmithKline at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01888471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.

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