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Maternal Antibody in Milk After Vaccination (MAMA)

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ClinicalTrials.gov Identifier: NCT03982732
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
European Society for Paediatric Infectious Diseases
Information provided by (Responsible Party):
St George's, University of London

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.

Condition or disease Intervention/treatment
Pertussis Vaccination Pregnancy Breastmilk Biological: Boostrix-IPV

Detailed Description:

Pertussis disease is a highly infectious respiratory illness caused by Bordetella pertussis, which can cause significant morbidity and mortality. There has been an increase in cases in many high income countries with high vaccination coverage and in an attempt to control this, antenatal vaccination programmes have been introduced in several countries, including the UK. Vaccination in pregnancy is a strategy which seeks to boost the maternal antibody levels, increase the placental transfer of antibody and consequently increase the antibody levels in the infant.

Human breast milk is a dynamic source of nutrition for the infant and is made up of many immunologically active components including antibody. The principal antibody in breastmilk is IgA and it has been shown that the amount of disease specific antibody in breastmilk can be increased by vaccination in pregnancy for a number of pathogens including pertussis. Secretory IgA (sIgA) plays an important role in immune exclusion in which it blocks adhesion of a pathogen onto a mucosal surface. As the first step of pertussis pathogenesis is the adhesion of bacteria to the ciliated respiratory epithelium in the nasopharynx and trachea there is a clear biological rationale for the hypothesis that receiving breast milk containing more IgA could enhance neonatal immunity and consequently the protective effects of vaccination in pregnancy.

The best time in pregnancy for administering the pertussis vaccination is debated in the literature, with some advocating vaccination in the second trimester and others supporting later vaccination to coincide the time of serum antibody peak with optimum placental transfer. This issue has been considered exclusively from the perspective of serum immunoglobulin G (IgG), but the impact of timing of vaccination in pregnancy on IgA levels in milk may also be important. Previous studies have shown that there is a peak in the pertussis specific IgA in breast milk at day 10 following vaccination, which then declines, and consequently there may be a significant difference in the amount of IgA available in the breastmilk for an infant born to a mother vaccinated at 20 weeks for example, compared to a mother vaccinated at 32 weeks. This may therefore have an impact on future guidelines on optimal time of vaccination in pregnancy.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Antibody in Milk After Vaccination
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : October 31, 2019


Group/Cohort Intervention/treatment
Women vaccinated at less than 24 weeks
Women receiving a pertussis containing vaccine at less than 24 weeks
Biological: Boostrix-IPV
Receipt of Boostrix IPV at three different gestational time periods

Women vaccinated at 24-27+6 weeks
Women receiving a pertussis containing vaccine at 24-27+6 weeks
Biological: Boostrix-IPV
Receipt of Boostrix IPV at three different gestational time periods

Women vaccinated at 28-31+6 weeks
Women receiving a pertussis containing vaccine at 28-31+6 weeks
Biological: Boostrix-IPV
Receipt of Boostrix IPV at three different gestational time periods




Primary Outcome Measures :
  1. Anti PT IgA at less than 48 hours in colostrum [ Time Frame: Within 48 hours of delivery ]
    Anti-pertussis toxin (PT) Immunoglobulin A (IgA) concentration in colostrum


Secondary Outcome Measures :
  1. Total IgA and IgG in colostrum and breastmilk [ Time Frame: Within 48 hours and at 14 and 42 days after delivery ]
    Total IgA and IgG concentration in colostrum and breastmilk

  2. Anti-PT IgA concentration in breastmilk [ Time Frame: At 14 and 42 days following delivery ]
    Anti-PT IgA concentration in breastmilk

  3. Anti-PT IgG concentration in colostrum and breastmilk [ Time Frame: Within 48 hours and at 14 and 42 days after delivery ]
    Anti-PT IgG concentration in colostrum and breastmilk

  4. Anti PT IgG concentration in maternal serum [ Time Frame: Within 48 hours of delivery ]
    Anti PT IgG concentration in maternal serum


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant must have been vaccinated in pregnancy.
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03982732


Contacts
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Contact: Anna Calvert, MBChB 02087253887 acalvert@sgul.ac.uk
Contact: Kirsty Le Doare 02087253887 kiledoar@sgul.ac.uk

Locations
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United Kingdom
St Georges University Hospital NHS Foundation Trust Recruiting
Tooting, London, United Kingdom, SW17 0QT
Contact: Anna Calvert       acalvert@sgul.ac.uk   
Sponsors and Collaborators
St George's, University of London
European Society for Paediatric Infectious Diseases
Investigators
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Study Director: Kirsty Le Doare St George's, Univeristy of London

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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03982732     History of Changes
Other Study ID Numbers: 18.0068
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs