Maternal Antibody in Milk After Vaccination

Pregnancy Clinical Trial

— MAMA  

Official title:

Maternal Antibody in Milk After Vaccination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982732
• Other study ID #: 18.0068
• Status: Recruiting
• Start date: August 7, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2019
• Source: St George's, University of London
• Contact: Anna Calvert, MBChB
• Phone: 02087253887
• Email: acalvert[@]sgul.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2019
• Est. primary completion date: August 31, 2019
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastmilk
• Pertussis
• Pregnancy
• Vaccination

Intervention

Biological:
• Boostrix-IPV
Receipt of Boostrix IPV at three different gestational time periods

Locations

Country	Name	City	State
United Kingdom	St Georges University Hospital NHS Foundation Trust	Tooting	London

Sponsors (2)

Lead Sponsor	Collaborator
St George's, University of London	European Society for Paediatric Infectious Diseases

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total IgA and IgG in colostrum and breastmilk	Total IgA and IgG concentration in colostrum and breastmilk	Within 48 hours and at 14 and 42 days after delivery
Secondary	Anti-PT IgA concentration in breastmilk	Anti-PT IgA concentration in breastmilk	At 14 and 42 days following delivery
Secondary	Anti-PT IgG concentration in colostrum and breastmilk	Anti-PT IgG concentration in colostrum and breastmilk	Within 48 hours and at 14 and 42 days after delivery
Secondary	Anti PT IgG concentration in maternal serum	Anti PT IgG concentration in maternal serum	Within 48 hours of delivery