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

Results (if applicable)

Not yet available.