Group B Strep Correlates of Protection Study

NCT06431217 | Completed

• 1 other identifier: GBS CoP
• Study Type: observational
• Target: 17,842
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Health; Child Health; Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• University of KwaZulu: collaborator
• University of Stellenbosch: collaborator
• University of Pretoria: collaborator
• University of Cape Town: collaborator

Study Sites (1)

Rmpru/Vpd

Johannesburg, Gauteng, 1862, South Africa

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood, Vaginal Swab collection, cord blood collection, DBS collection

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: May 28, 2024
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)