Development of a Serocorrelate of Protection Against Invasive Group B Streptococcus Disease

NCT04735419 | Unknown

• 1 other identifier: 2020.0176
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

A multicentre study to provide evidence that the relationship between an immune marker value (anti-GBS IgG concentration) and the probability of invasive GBS (iGBS) disease in infants less than 90 days of age is sufficiently strong that a vaccine able to induce an immune response will lead to a meaningful decrease in the probability of iGBS disease.

Conditions

Streptococcus Agalactiae Infection

Keywords

Vaccine; Pregnancy; case control study; serocorrelate of protection

Outcome Measures

Primary Outcomes (2)

• Correlates objective

  • To provide initial data on the relationship between antibody and iGBS disease risk by estimating the odds ratio of iGBS disease for antibody concentrations above various thresholds for STIII

  36 months

• Kinetics objective

  • To determine whether antibody concentrations obtained at the time of disease (acute disease sample) can be used to predict cord antibody concentrations at birth in cases of iGBS STIII disease

  12 months

Secondary Outcomes (3)

• Correlates other than STIII

  36 months

• Kinetics other than STIII

  12 months

• Controls objective

  36 months

Other Outcomes (2)

• Risk reduction objective

  36 months

• Other pathogens sub-study

  36 months

Study Arms (2)

Cases

Cases are defined as infants who develop invasive GBS disease (iGBS disease= isolation of GBS from a normally sterile site, i.e. blood or CSF) in the first 90 days of life.

Other: No intervention

Controls

Controls are defined as infants who are exposed to the same serotype of GBS at birth as the case - but who do not develop iGBS disease in the first 90 days of life.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Cases; Controls

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women giving birth in maternity units in England, Scotland and Wales participating in the GBS3 study and their infants in the first 3 month of life

You may not qualify if:

• For iGBS disease case recruitment, an infant is not eligible unless a parent/person with parental responsibility gives informed consent For iGBS disease control recruitment, a mother is not eligible unless she gives informed consent.

Sponsors & Collaborators

• St George's, University of London: lead
• Medical Research Council: collaborator
• University of Nottingham: collaborator
• Public Health England: collaborator

Study Sites (1)

St George's University of London

London, SW17 ORE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum Bacterial isolates

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Paul Heath

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Azzouzi

CONTACT

02082666488; nazzouzi@sgul.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: December 1, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

GB (1)