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Maternal Antibody in Milk After Vaccination

Maternal Antibody in Milk After Vaccination

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03982732
Acronym
MAMA
Enrollment
50
Registered
2019-06-11
Start date
2018-08-07
Completion date
2019-10-31
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis, Vaccination, Pregnancy, Breastmilk

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.

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.

Interventions

BIOLOGICALBoostrix-IPV

Receipt of Boostrix IPV at three different gestational time periods

Sponsors

European Society for Paediatric Infectious Diseases
CollaboratorOTHER
St George's, University of London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Anti PT IgA at less than 48 hours in colostrumWithin 48 hours of deliveryAnti-pertussis toxin (PT) Immunoglobulin A (IgA) concentration in colostrum

Secondary

MeasureTime frameDescription
Total IgA and IgG in colostrum and breastmilkWithin 48 hours and at 14 and 42 days after deliveryTotal IgA and IgG concentration in colostrum and breastmilk
Anti-PT IgA concentration in breastmilkAt 14 and 42 days following deliveryAnti-PT IgA concentration in breastmilk
Anti-PT IgG concentration in colostrum and breastmilkWithin 48 hours and at 14 and 42 days after deliveryAnti-PT IgG concentration in colostrum and breastmilk
Anti PT IgG concentration in maternal serumWithin 48 hours of deliveryAnti PT IgG concentration in maternal serum

Countries

United Kingdom

Contacts

Primary ContactAnna Calvert, MBChB
acalvert@sgul.ac.uk02087253887
Backup ContactKirsty Le Doare
kiledoar@sgul.ac.uk02087253887

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026