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GBS Sero-correlate of Protection (V98_28OBTP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215226
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Shabir Madhi, University of Witwatersrand, South Africa

Brief Summary:
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.

Condition or disease
Invasive Group B Streptococcus Disease

Detailed Description:

Group B Streptococcus (GBS) is a leading cause of invasive disease during the neonatal period in developed and developing countries. The global incidence of disease is 0.53 per 1000 live births, though a substantially higher incidence has been reported from South Africa (3 per 1000 live births). Of the disease-causing serotypes, types Ia and III account for over 70% of invasive disease in young infants. The introduction of screening for maternal rectovaginal GBS colonization, with subsequent treatment of colonized women with intrapartum antibiotic prophylaxis (IAP) at delivery, has led to a >80% reduction in the incidence of disease in some settings (Schrag, 2012). However, the residual burden of early-onset disease (EOD) in countries which have implemented universal screening and IAP remains similar to the incidence of late-onset disease (LOD), which has not declined over time. The resources necessary to implement a screening and IAP program has limited the establishment of this intervention in other developed and most developing countries.

GBS capsular polysaccharide-protein conjugate vaccines (GBS-CV) aimed at the immunization of pregnant women, with protection of the newborn expected from trans-placental acquisition of the induced antibodies in utero have been developed.

There are a number of challenges to undertaking a large efficacy trial of GBS-CV aimed at licensure of this vaccine. Consequently, licensure of GBS-CV may depend on establishing an immunologic/serologic correlate of protection against invasive disease in newborns, as has been successfully motivated for and adopted in the licensure pathway of meningococcal vaccines. Although previous studies have aimed to identify serotype-specific correlates of anticapsular antibody protection against invasive GBS disease during early-infancy; differences in study-design, age-range of invasive-cases, antibody assay methods and a lack of standardized reference serum between tests mean a robust sero-correlate of protection against GBS has yet to be identified.

We propose to conduct a case control study nested within a prospective, longitudinal cohort of mothers and their infants <=90 days of age, at one academic hospital center in South Africa. The limited intrapartum antibiotic exposure (10-12% deliveries), relatively high incidence of both EOD and LOD (2 per 1000 live births and 1 per 1000 live births respectively) and standardized laboratory surveillance (for case identification) offers an optimal setting in which to establish correlates of protection against the GBS serotypes that predominate in this setting (serotypes Ia and III for EOD and serotype III for LOD).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 35274 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged <=90 Days
Study Start Date : July 2014
Actual Primary Completion Date : December 9, 2016
Actual Study Completion Date : December 31, 2016



Primary Outcome Measures :
  1. Risk of early onset Group B Steptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery. [ Time Frame: Birth to 6 days of age ]
    Early onset Group B Streptococcus disease due to serotypes Ia & III


Secondary Outcome Measures :
  1. Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery [ Time Frame: 7 to 90 days ]
    Late onset Group B Streptococcus disease due to serotype III


Biospecimen Retention:   Samples Without DNA
Cord blood and maternal blood (serum samples) Vaginal swab samples from mothers Invasive GBS isolates from cases


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women aged 18 years or older attending for antenatal care or delivery at Chris Hani Baragwanath Academic hospital, and infants who develop GBS disease at the other 2 hospitals in the Johannesburg area
Criteria

Inclusion Criteria:

  • (i) Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.

(ii) Subjects aged ≥18 years. (iii) Able to understand and comply with planned study procedures. (iv) Provides written informed consent.

Exclusion Criteria:

  • (i) Refuses to consent to study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215226


Locations
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South Africa
Respiratory and Meningeal Pathogen Research Unit
Soweto, Johannesburg, Gauteng, South Africa, 2013
Sponsors and Collaborators
University of Witwatersrand, South Africa
Novartis Vaccines

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shabir Madhi, Medical officer, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT02215226    
Other Study ID Numbers: V98_28OBTP
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Keywords provided by Shabir Madhi, University of Witwatersrand, South Africa:
Group B Streptococcus, early onset disease, late onset disease, anticapsular antibodies, serotype specific