MAMA study
Research type
Research Study
Full title
Maternal Antibody in Milk After vaccination: MAMA study
IRAS ID
244790
Contact name
Nadia Azzouzi
Contact email
Sponsor organisation
St George's, University of London
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
"Research Summary"
Whooping cough (pertussis) is a highly infectious respiratory illness which can cause significant disease and death. There has been an increase in cases in many high income countries including the UK despite the good uptake of childhood vaccinations against whooping cough. The disease causes particular problems to babies who are infected in the first weeks of life and in many countries vaccination programmes offered to pregnant women have been introduced to protect infants from birth. Whooping cough vaccination in pregnancy seeks to increase the amount of antibody (a protein which fights specific infections) against whooping cough so that more is available to cross the placenta leading to higher levels of anti-whooping cough antibody in the baby at birth.Breastmilk is an ideal source of nutrition for babies and has many active elements which help to improve their immunity, including antibody. Vaccination in pregnancy has been shown to increase the amount of antibody in breastmilk which may provide a further source of protection for the infant after delivery to enhance the protection they have already received during the pregnancy.
Whooping cough vaccination in pregnancy has been shown to be effective in preventing cases of disease, but there is some uncertainty about when in pregnancy is best to offer the vaccine to provide the best protection to babies. In this study we will investigate the levels of antibody in maternal milk when women have been vaccinated at different time points in pregnancy so we can establish the variability. The aim of this study is to provide information to allow us to develop a larger study which can look at this in more detail. Improving our knowledge about the impact of vaccinating women at different time points in pregnancy will facilitate discussions about the optimal timing of whooping cough vaccination in pregnancy.
"Summary of Results"
In the MAMA study we investigated the amount of antibody (a protein which protects against infection) found in the breastmilk of women who had received a pertussis containing vaccine when they were pregnant. The women were divided into three study groups based on how many weeks pregnant they were when they received the vaccine (<24 weeks, 24-27+6 weeks, 28-31+6 weeks).We collected a sample of colostrum (the thick yellow breastmilk produced in the first days following delivery) within 48 hours of delivery, along with a blood sample taken at the same time, and breastmilk samples at 2 and 6 weeks. We measured the amount of two types of antibody, immunoglobulin G (IgG) and immunoglobulin A (IgA) in the colostrum and breastmilk samples and the amount of IgG in the blood samples and compared the amounts found in women vaccinated in the three time windows.
We recruited 50 participants, and breastmilk samples were available for analysis for 38 participants at the first visit (colostrum sample), 44 participants at the second visit (2 weeks) and 40 participants at the third visit (6 weeks) and a serum sample was available for 49 participants at the first visit.
There was no difference in the amount of IgA and IgG found in the colostrum of women vaccinated in the different time periods. In a blood sample taken at the same time there was also no difference in the amount of IgG between the women vaccinated in different time windows. Analysis of breastmilk samples collected at 2 and 6 weeks also found no difference in the amounts of IgA and IgG in the breastmilk.
Conclusion
Although this was a small study and definite conclusions cannot be reached, there were no differences found in the amounts of antibody in colostrum, breastmilk or serum of women vaccinated in three different time periods. This small study suggests that vaccination at any point within the time window recommended in the UK results in similar antibody levels in colostrum and breastmilk.REC name
Wales REC 7
REC reference
18/WA/0171
Date of REC Opinion
9 May 2018
REC opinion
Favourable Opinion