Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays

NCT04023929 | Unknown

• 1 other identifier: 2019.0116
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to allow cord blood sample collection from the cords of babies born in three gestational age windows: ≥37 gestational weeks, 32-36+6 gestational weeks and less than 32 gestational weeks to investigate whether the result obtained using a standard hSBA assay is comparable to that achieved using complement from a gestation matched population for meningococcal B and pertussis.

Conditions

Pertussis; Meningococcal Disease; Prematurity

Outcome Measures

Primary Outcomes (1)

• SBA assay results

  Comparison of the SBA assay results obtained when using adult human complement compared with a gestationally matched complement source

  Cord blood sampling will be performed at the time of delivery

Study Arms (3)

Term babies

Babies who are born at or after 37 gestational weeks.

Procedure: Cord blood sampling

Preterm babies

Babies who are born between 32 and 36+6 gestational weeks.

Procedure: Cord blood sampling

Very preterm babies

Babies who are born before 32 gestational weeks.

Procedure: Cord blood sampling

Interventions

Cord blood sampling PROCEDURE

A cord blood sample will be obtained after the baby has been delivered and the cord has been clamped and cut.

Preterm babies; Term babies; Very preterm babies

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Participants need to be pregnant to be recruited
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• Pregnant and planning to deliver at St George's University Hospitals NHS Foundation Trust

You may not qualify if:

• Aged less than 16 years
• Known complement deficiency

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's, University of London

London, SW17 0RE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord blood samples will be collected as part of this study.

MeSH Terms

Conditions

Whooping Cough; Meningococcal Infections; Premature Birth

Interventions

Cordocentesis

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neisseriaceae Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anna Calvert, MBChB

  St George's, Univeristy of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Calvert, MBChB

CONTACT

02087253887; acalvert@sgul.ac.uk

Kirsty Le Doare, PhD

CONTACT

02087253887; kiledoar@sgul.ac.uk

Study Design

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

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 18, 2019
• Study Start: October 28, 2020
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)