PertussisMAMANCT03982732
Maternal Antibody in Milk After Vaccination
An observational study of Pertussis and Vaccination, run by St George's, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pertussis, Vaccination, Pregnancy
- What is being tested?
- Boostrix-IPV
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Aug 2018to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women who received a pertussis vaccination between 16 and 32 weeks and are pregnant or within 48 hours of delivery.
Who may be able to join
- Singleton pregnancy
- Received pertussis vaccination between 16 and 32 gestational weeks
- Planning to breastfeed
Who cannot join
- Received vaccination outside of the 16-32 week window
- Not planning to breastfeed
- Diagnosis of an immunodeficiency syndrome
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Georges University Hospital NHS Foundation Trust
Tooting, London, SW17 0QT
Anna Calvert, acalvert@sgul.ac.uk
About this study
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.
Read the 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.
- Conditions
- Pertussis, Vaccination, Pregnancy, Breastmilk
- Being tested
- Boostrix-IPV
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix-IPVBiological
Receipt of Boostrix IPV at three different gestational time periods
| Study group | Role | What they receive |
|---|---|---|
| Women vaccinated at less than 24 weeks | Women receiving a pertussis containing vaccine at less than 24 weeks Receives: Biological: Boostrix-IPV | |
| Women vaccinated at 24-27+6 weeks | Women receiving a pertussis containing vaccine at 24-27+6 weeks Receives: Biological: Boostrix-IPV | |
| Women vaccinated at 28-31+6 weeks | Women receiving a pertussis containing vaccine at 28-31+6 weeks Receives: Biological: Boostrix-IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti PT IgA at less than 48 hours in colostrum
Anti-pertussis toxin (PT) Immunoglobulin A (IgA) concentration in colostrum
Measured: Within 48 hours of delivery
Secondary outcomes (4)
Total IgA and IgG in colostrum and breastmilk
Total IgA and IgG concentration in colostrum and breastmilk
Measured: Within 48 hours and at 14 and 42 days after delivery
Anti-PT IgA concentration in breastmilk
Anti-PT IgA concentration in breastmilk
Measured: At 14 and 42 days following delivery
Anti-PT IgG concentration in colostrum and breastmilk
Anti-PT IgG concentration in colostrum and breastmilk
Measured: Within 48 hours and at 14 and 42 days after delivery
Anti PT IgG concentration in maternal serum
Anti PT IgG concentration in maternal serum
Measured: Within 48 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start7 Aug 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Paediatric Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Kirsty Le Doare, Study director, St George's, Univeristy of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982732
- Sponsor's protocol ID
- 18.0068
- Acronym
- MAMA
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Antibody in Milk After Vaccination
- ClinicalTrials.gov ID
- NCT03982732
- Acronym / sponsor ID
- MAMA / 18.0068
- Conditions
- Pertussis, Vaccination, Pregnancy, Breastmilk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- European Society for Paediatric Infectious Diseases
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women vaccinated at less than 24 weeks | – | Biological: Boostrix-IPVWomen receiving a pertussis containing vaccine at less than 24 weeks |
| Women vaccinated at 24-27+6 weeks | – | Biological: Boostrix-IPVWomen receiving a pertussis containing vaccine at 24-27+6 weeks |
| Women vaccinated at 28-31+6 weeks | – | Biological: Boostrix-IPVWomen receiving a pertussis containing vaccine at 28-31+6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women who received a pertussis vaccination between 16 and 32 weeks and are pregnant or within 48 hours of delivery.
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Received pertussis vaccination between 16 and 32 gestational weeks
- Planning to breastfeed
Key exclusion criteria (4 listed)
- Received vaccination outside of the 16-32 week window
- Not planning to breastfeed
- Diagnosis of an immunodeficiency syndrome
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boostrix-IPVReceipt of Boostrix IPV at three different gestational time periods | Biological | Women vaccinated at 24-27+6 weeks, Women vaccinated at 28-31+6 weeks, Women vaccinated at less than 24 weeks |
Primary outcome
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
4 secondary outcomes
Total IgA and IgG in colostrum and breastmilk
Time frame: Within 48 hours and at 14 and 42 days after delivery
Anti-PT IgA concentration in breastmilk
Time frame: At 14 and 42 days following delivery
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 maternal serum
Time frame: Within 48 hours of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
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RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Le Doare study director
St George's, Univeristy of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis and Vaccination, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Calvert, MBChB (02087253887, acalvert@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti PT IgA at less than 48 hours in colostrum (time frame: Within 48 hours of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.