Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431217
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2019-03-05
Brief Title:
Group B Strep Correlates of Protection Study
Sponsor:
University of Witwatersrand South Africa
Organization:
University of Witwatersrand South Africa
Study Overview
Official Title:
Investigating for Immunological Correlates of Protection Against Invasive Group B Streptococcus Disease in Infants Less Than 90 Days of Age
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GBSCoP
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
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 15000 mother-infant dyads will be enrolled at Chris Hani Baragwanath Academic Hospital n10000 and Rahima Moosa Mother and Child Hospitaln5000 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
A cohort of 15000 mother-infant dyads will be enrolled at Chris Hani Baragwanath Academic Hospital n10000 and Rahima Moosa Mother and Child Hospitaln5000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None