Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2018-08-07
2019-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women vaccinated at less than 24 weeks
Women receiving a pertussis containing vaccine at less than 24 weeks
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
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
Boostrix-IPV
Receipt of Boostrix IPV at three different gestational time periods
Interventions
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Boostrix-IPV
Receipt of Boostrix IPV at three different gestational time periods
Eligibility Criteria
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Inclusion Criteria
* Received pertussis vaccination between 16 and 32 gestational weeks
* Planning to breastfeed
Exclusion Criteria
* Not planning to breastfeed
* Diagnosis of an immunodeficiency syndrome
* Multiple pregnancy
18 Years
FEMALE
No
Sponsors
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European Society for Paediatric Infectious Diseases
OTHER
St George's, University of London
OTHER
Responsible Party
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Principal Investigators
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Kirsty Le Doare
Role: STUDY_DIRECTOR
St George's, Univeristy of London
Locations
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St Georges University Hospital NHS Foundation Trust
Tooting, London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18.0068
Identifier Type: -
Identifier Source: org_study_id
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