Trials / Completed
CompletedNCT06431217
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 17,842 (actual)
- Sponsor
- University of Witwatersrand, South Africa · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2024-05-28
- Last updated
- 2024-12-11
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT06431217. Inclusion in this directory is not an endorsement.