Group B Strep Correlates of Protection Study

Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries.

The study aims to bolster the evidence base of establishing a sero-correlate of protection against invasive GBS disease in infants.

These sero-correlates of protection will be used to study the effectiveness of GBS vaccine against invasive disease.

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Key information

Conditions

Maternal Health Child Health Communicable Diseases Disease Attributes Infections Infectious Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rmpru/Vpd

Johannesburg, Gauteng, 1862, South Africa

About this study

Observational Case-Control Study

A cohort of 15,000 mother-infant dyads will be enrolled at Chris Hani Baragwanath Academic Hospital (n=10,000) and Rahima Moosa Mother and Child Hospital(n=5,000) over an 18-24-month period, anticipated to start in the first quarter of 2019.
Enrolment into the cohort study will occur at antenatal clinic, during the early stages either of labour or immediately post-delivery.
In parallel, enrolment of GBS cases will occur at the time of diagnosis of invasive GBS disease. These "retrospective cases" will be enrolled at multiple facilities across South Africa.
Infants will be followed up until 89 days of age to identify cases of suspected sepsis and hospitalizations.

Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Pregnant women attending for antenatal care at one of the participating antenatal-clinics and/or delivering at CHBAH or RMMCH.
Subjects aged ≥18 years.
Able to understand and comply with planned study procedures.
Provides written informed consent.

Exclusion criteria

Refusal to consent to study participation.
Receipt of any blood products in the past 4 weeks or anticipated during labour.

Treatment and study plan

Primary outcomes

Primary Objective

Time frame: 1 - 1.5 years

Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases. Anti-CPS IgG concentrations were determined with the use of a quantitative direct immunoassay (Luminex) that measured levels of antibodies binding to CPS serotypes Ia, Ib, and II through V.

Sponsors and collaborators

Lead sponsor

University of Witwatersrand, South Africa

Other

Collaborators

University of Cape Town
University of KwaZulu
University of Pretoria
University of Stellenbosch

Registry information

Official study title

Investigating for Immunological Correlates of Protection Against Invasive Group B Streptococcus Disease in Infants Less Than 90 Days of Age.

Acronym: GBSCoP

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: May 28, 2024
Registry last updated: Dec 11, 2024

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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