NCT02215226

Brief Summary

Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2016

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

2.4 years

First QC Date

August 11, 2014

Last Update Submit

September 12, 2018

Conditions

Invasive Group B Streptococcus Disease

Keywords

Group B Streptococcus, early onset disease, late onset disease, anticapsular antibodies, serotype specific

Outcome Measures

Primary Outcomes (1)

  • Risk of early onset Group B Steptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery.

    Early onset Group B Streptococcus disease due to serotypes Ia \& III

    Birth to 6 days of age

Secondary Outcomes (1)

  • Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery

    7 to 90 days

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women aged 18 years or older attending for antenatal care or delivery at Chris Hani Baragwanath Academic hospital, and infants who develop GBS disease at the other 2 hospitals in the Johannesburg area

You may qualify if:

  • (i) Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
  • (ii) Subjects aged ≥18 years. (iii) Able to understand and comply with planned study procedures. (iv) Provides written informed consent.

You may not qualify if:

  • (i) Refuses to consent to study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory and Meningeal Pathogen Research Unit

Soweto, Johannesburg, Gauteng, 2013, South Africa

Location

Related Publications (3)

  • Gent V, Dhar N, Izu A, Jones S, Dangor Z, Briner C, Hosken N, Kwatra G, Madhi SA. Association of serum anti-gbs2106 protein immunoglobulin G (IgG) in newborns and risk reduction of invasive group B streptococcus disease during early infancy. Vaccine. 2025 Apr 30;54:127016. doi: 10.1016/j.vaccine.2025.127016. Epub 2025 Mar 14.

    PMID: 40088514DERIVED

  • Madhi SA, Izu A, Kwatra G, Jones S, Dangor Z, Wadula J, Moultrie A, Adam Y, Pu W, Henry O, Briner C, Cutland CL. Association of Group B Streptococcus (GBS) Serum Serotype-Specific Anticapsular Immunoglobulin G Concentration and Risk Reduction for Invasive GBS Disease in South African Infants: An Observational Birth-Cohort, Matched Case-Control Study. Clin Infect Dis. 2021 Sep 7;73(5):e1170-e1180. doi: 10.1093/cid/ciaa1873.

    PMID: 33341870DERIVED

  • Jallow S, Agosti Y, Kgagudi P, Vandecar M, Cutland CL, Simoes EAF, Nunes MC, Suchard MS, Madhi SA. Impaired Transplacental Transfer of Respiratory Syncytial Virus-neutralizing Antibodies in Human Immunodeficiency Virus-infected Versus -uninfected Pregnant Women. Clin Infect Dis. 2019 Jun 18;69(1):151-154. doi: 10.1093/cid/ciy1071.

    PMID: 30561563DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord blood and maternal blood (serum samples) Vaginal swab samples from mothers Invasive GBS isolates from cases

MeSH Terms

Conditions

Late Onset Disorders

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical officer

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 13, 2014

Study Start

July 1, 2014

Primary Completion

December 9, 2016

Study Completion

December 31, 2016

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

ZA(1)