Group B Strep Correlates of Protection Study (GBSCoP)

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

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.

Study Overview

• Status: Completed
• Conditions: Maternal Health; Infectious Diseases; Child Health

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 17842

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1862
      • Rmpru/Vpd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

5.1.1. Cohort population Maternal-newborn dyads enrolled at CHBAH or RMMCH prior to or during delivery-admission, from whom maternal and cord blood are collected.

5.1.2. Control population Controls will be defined as newborns born to mothers enrolled into the cohort study, whose mother is colonized by a serotype homologous to that of a case to which they matched, but who do not develop invasive GBS disease within 90 days of life. Cases and controls will matched by serotype, gestational age (34-<37 weeks and ≥37 weeks gestation) and maternal age (<25 years, 25-<35 years and ≥35 years). Maternal HIV infection status will be assessed as an effect modifier.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	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.	1 - 1.5 years

Collaborators and Investigators

• Sponsor: University of Witwatersrand, South Africa
• Collaborators: University of Stellenbosch; University of Cape Town; University of KwaZulu; University of Pretoria

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: GBS CoP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No