Maternal Antibody in Milk After Vaccination

NCT03982732 | Unknown

• 1 other identifier: 18.0068
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Single-centre observational pilot study exploring pertussis specific antibody concentration in the breastmilk of women vaccinated against pertussis in pregnancy at different gestational ages. This study is made up of two stages: first stage to confirm recruitment methods and optimise the laboratory assay and a second stage to complete recruitment for the pilot study.

Conditions

Pertussis; Vaccination; Pregnancy; Breastmilk

Outcome Measures

Primary Outcomes (1)

• Anti PT IgA at less than 48 hours in colostrum

  Anti-pertussis toxin (PT) Immunoglobulin A (IgA) concentration in colostrum

  Within 48 hours of delivery

Secondary Outcomes (4)

• Total IgA and IgG in colostrum and breastmilk

  Within 48 hours and at 14 and 42 days after delivery

• Anti-PT IgA concentration in breastmilk

  At 14 and 42 days following delivery

• Anti-PT IgG concentration in colostrum and breastmilk

  Within 48 hours and at 14 and 42 days after delivery

• Anti PT IgG concentration in maternal serum

  Within 48 hours of delivery

Study Arms (3)

Women vaccinated at less than 24 weeks

Women receiving a pertussis containing vaccine at less than 24 weeks

Biological: Boostrix-IPV

Women vaccinated at 24-27+6 weeks

Women receiving a pertussis containing vaccine at 24-27+6 weeks

Biological: Boostrix-IPV

Women vaccinated at 28-31+6 weeks

Women receiving a pertussis containing vaccine at 28-31+6 weeks

Biological: Boostrix-IPV

Interventions

Boostrix-IPV BIOLOGICAL

Receipt of Boostrix IPV at three different gestational time periods

Women vaccinated at 24-27+6 weeks; Women vaccinated at 28-31+6 weeks; Women vaccinated at less than 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant must have been vaccinated in pregnancy.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who received a pertussis vaccination between 16 and 32 weeks and are pregnant or within 48 hours of delivery.

You may qualify if:

• Singleton pregnancy
• Received pertussis vaccination between 16 and 32 gestational weeks
• Planning to breastfeed

You may not qualify if:

• Received vaccination outside of the 16-32 week window
• Not planning to breastfeed
• Diagnosis of an immunodeficiency syndrome
• Multiple pregnancy

Sponsors & Collaborators

• St George's, University of London: lead
• European Society for Paediatric Infectious Diseases: collaborator

Study Sites (1)

St Georges University Hospital NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will collect samples of colostrum within the first 48 hours following delivery along with a blood sample and a further breastmilk sample at 2 and 6 weeks following delivery.

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Kirsty Le Doare

  St George's, Univeristy of London

  STUDY DIRECTOR

Central Study Contacts

Anna Calvert, MBChB

CONTACT

02087253887; acalvert@sgul.ac.uk

Kirsty Le Doare

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: June 10, 2019
• First Posted: June 11, 2019
• Study Start: August 7, 2018
• Primary Completion: August 31, 2019
• Study Completion: October 31, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)