Immunising Mums Against Pertussis 3
Condition: Whooping Cough; Maternal Vaccine Exposure; Immunization; Infection
MeSH terms: Whooping Cough
Study type: Observational

Summary: 
      This study will aim to recruit at least 70 children who participated in the iMAP2 study whose
      mothers received a pertussis vaccine in pregnancy as part of the iMAP2 trial and at least 15
      children born to mothers who did not receive a pertussis vaccine in pregnancy. Blood samples
      will be obtained prior to and one month after the routine preschool booster vaccination and
      vaccine responses compared between children whose mothers received one of two pertussis
      vaccines or no pertussis vaccine in pregnancy. Children will be vaccinated with the routine
      booster vaccines by the study team on the same visit as the pre-vaccination bloods are taken.
    

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.
    

Intervention name(s): Pre-school booster vaccine
Intervention type(s): Biological
Intervention description(s): Routine vaccination with pre-school booster vaccine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who participated in the iMAP2 study of age to receive the routine pre-school
        booster vaccinations (i.e. from 3 years and 4 months of age)
      
Biospecimen description: 
      Venous blood sample to access serum sample to investigate antibody response towards
      pre-school booster vaccination