Immunising Mums Against Pertussis 3 (iMAP3)
Study Overview
Status
Intervention / Treatment
Detailed Description
In the UK, all pregnant women are offered a whooping cough-containing vaccine during pregnancy. This protects newborn infants against whooping cough, but there have been some concerns that this vaccination in pregnancy may affect the response to childhood vaccinations.
A preceding study called immunising Mums Against Pertussis 2 (iMAP2) was conducted involving pregnant women randomised to receive one of two different whooping cough-containing vaccines, with a control group also recruited, and the antibody levels in their infants were measured at age 2, 5 and 13 months.
This study, immunising Mums Against Pertussis 3 (iMAP3), is a follow up study of children who participated in iMAP2, to investigate the sustained impact of whooping cough vaccination in pregnancy on childhood vaccine responses.
This study will investigate the antibody levels in these children before and after the routine pre-school booster (DTaP/IPV vaccination) vaccine. It will help the Department of Health continue to ensure the best protection is offered to the population.
Those eligible for the study are children who participated in the iMAP2 study who have reached the age for pre-school booster vaccination (from age 3 years 4 months).
The study period will be approximately 4-6 weeks with two study visits. The first visit will take place when the child is around 3 years and 4 months of age. After informed consent a blood sample will be obtained followed by administration of the pre-school booster vaccine. At the second visit another blood sample will be obtained. These blood tests will measure the level of protective antibody against the components of the pre-school booster vaccine. Visits will take place either in the child's home or at a suitable clinical setting within the study team's sites.
The study will be run by St. George's, University of London, in collaboration with St George's University Hospitals NHS Foundation Trust, Oxford Vaccine Group and Bristol Children's Vaccine Centre.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gloucester, United Kingdom
- Gloucestershire NHS Trust
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London, United Kingdom, SW170RE
- St George's, University of London
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Oxford, United Kingdom
- Oxford Vaccine Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age eligible for routine pre-school booster vaccinations (i.e. from 3 years and 4 months of age)
- Participated in the iMAP2 trial
- Informed consent by a parent or legal guardian
Exclusion Criteria:
Permanent exclusion criteria:
- Fulfil any of the contraindications to vaccination specified in The Green Book on Immunisation (https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book)
- Received any additional pertussis containing vaccine after the routine 16 week booster
- Previous or concurrent participation in an interventional study other than iMAP2 if, in the opinion of the investigator, this may influence the objectives of this study
Temporary exclusion criteria:
- If the child has an axillary/aural temperature ≥ 38°C then vaccination and blood sampling will be postponed until resolution of fever. If the child is acutely unwell, vaccination will be postponed until resolution
- If the child is receiving antibiotics (other than long term prophylaxis) vaccination should be postponed until 48 hours after the conclusion of the course
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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iMAP2 participants where their mothers received REPEVAX
Children who participated in iMAP2 study whose mothers received a pertussis-containing vaccine during pregnancy called REPEVAX
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Routine vaccination with pre-school booster vaccine
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iMAP2 participants where their mothers received BOOSTRIX-IPV
Children who participated in iMAP2 study whose mothers receives a pertussis-containing vaccine during pregnancy called BOOSTRIX-IPV
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Routine vaccination with pre-school booster vaccine
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|
iMAP2 participants where their mothers received no vaccine
Children who participated in iMAP2 study whose mothers did not receive a pertussis-containing vaccine during pregnancy
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Routine vaccination with pre-school booster vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fold-difference in anti-PT IgG geometric mean concentration (GMC) in children prior to booster vaccination
Time Frame: Up to a maximum of 3 years from the date of the last recruited participant
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To compare anti-pertussis toxin (PT) IgG concentrations at preschool age (around 3 years 4 months) and before receipt of the routine pre-school booster vaccine, in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
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Up to a maximum of 3 years from the date of the last recruited participant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fold-difference in anti-PT IgG geometric mean concentration (GMC) in children one month after booster vaccination
Time Frame: Up to a maximum of 3 years from the date of the last recruited participant
|
To compare anti-pertussis toxin (PT) IgG concentrations at one month after receipt of the pre-school booster vaccine in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
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Up to a maximum of 3 years from the date of the last recruited participant
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GMC of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3) prior to and one month after booster vaccination
Time Frame: Up to a maximum of 3 years from the date of the last recruited participant
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To compare antibody concentrations to other pertussis antigens [IgG to filamentous haemagglutinin (FHA) and fimbrial antigens 2 and 3 (FIM 2 and 3)], before and one month after receipt of a pre-school booster vaccine in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
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Up to a maximum of 3 years from the date of the last recruited participant
|
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Anti-tetanus toxoid IgG GMC and anti-diphtheria toxoid IgG GMC prior to and one month after booster vaccination
Time Frame: Up to a maximum of 3 years from the date of the last recruited participant
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To compare antibody concentrations / titres to tetanus toxoid and diphtheria toxoid before and one month after receipt of a pre-school vaccine in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
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Up to a maximum of 3 years from the date of the last recruited participant
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Collaborators and Investigators
Investigators
- Principal Investigator: Paul T Heath, MBBS FRCPCH, St George's, University of London
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17.0269
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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