OpTIMUM

Optimising Timing of whooping cough Immunisation in MUMs

Follow up completed, laboratory analysis in progress.

Aim of the study: To investigate the impact of timing on the antibody response to whooping cough vaccination in pregnancy

Inclusion and exclusion criteria

Inclusion:

  • Pregnant and not yet having received pertussis vaccination
  • Willing and able to comply with study procedures and provide informed consent
  • Documentation of a 20-week anomaly scan with no life limiting congenital anomalies identified
  • At ≤23+6 gestational weeks

Exclusion:

  • Age less than 16 years
  • Confirmed or suspected pertussis in previous five years
  • Known diagnosis of immune deficiency
  • Receiving immunosuppressive medication within six months of enrolment in the study (this does not include inhaled or topical steroids)
  • In the opinion of the investigator is unlikely to complete follow up

What participating in the study involves?

Participants will be recruited in pregnancy prior to receiving a pertussis containing vaccine and will be randomised into one of three groups receiving the vaccine at three different time periods: ≤23+6, 24-27+6 and 28-31+6 weeks of gestation. Women will be involved in the study from the time of enrolment at around 20 weeks to the time of delivery (a period of around 20-22 weeks in total), and their infants will be involved in the study from birth until the age of 5 months (around 5 months in total).

Each maternal participant will have four study visits: screening, vaccination, 14 days following vaccination and at delivery, and infants will have a study visit 28-70 days after their third primary vaccination (around 5-7 months of age). Two sites will be involved in a sub-study investigating whooping cough antibody in breastmilk after vaccination and participants taking part in this will have two additional study visits following delivery.  (Table 1)

Table 1: Summary of study visits

Visit NumberScreening visitVaccination visitFollow up visitDelivery visitBreastmilk sub-study visit 1*Breastmilk sub-study visit 2*Infant visit
TimingAt or before 23+6 weeksAccording to study allocationV+14 (+/- 2)Delivery<48 hours from deliveryD+14(+/- 2)28-70 days following third pertussis vaccination
ActivityScreening & enrolment

 

Maternal blood sampling and vaccination. Diary card provided.

Questionnaire.

Maternal blood sampling. Diary card collected.Maternal blood and cord blood samplingColostrum samplingCollection of breastmilk sampleInfant blood sampling

Collection of breastmilk sample if still breastfeeding

Results (if applicable)

Not yet available.