Group B Strep Correlates of Protection Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06431217

Acronym

GBSCoP

Enrollment

17842

Registered

2024-05-28

Start date

2019-03-01

Completion date

2020-12-31

Last updated

2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Health, Infectious Diseases, Maternal Health

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary Objective	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.

Countries

South Africa

Outcome results