Optimising the Timing of Whooping Cough Immunisation in MUMs
试验速览
- 阶段
- 4 期
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- Pertussis specific antibody concentration in cord blood of term infants
研究概览
简要总结
A multicentre study to evaluate the impact of timing of whooping cough (pertussis) vaccination in pregnancy, with participants randomised to receive whooping cough vaccination at one of three time points in pregnancy.
详细描述
Pertussis is a highly infectious respiratory illness caused by Bordetella pertussis, which characteristically causes paroxysms of coughing with an associated inspiratory 'whoop'. In young infants the clinical presentation can be atypical, is frequently associated with apnoeic episodes and can cause significant morbidity and mortality. Following the introduction of pertussis vaccination into routine infant schedules worldwide there was a significant reduction in the incidence of pertussis. However, recently in a number of countries, despite high vaccine coverage, there has been a resurgence of pertussis disease associated with an increase in infant deaths. Various strategies to control the increasing burden of infant pertussis disease have been considered including cocooning, a strategy in which close contacts of an infant are vaccinated, a neonatal dose of a pertussis containing vaccine, the addition of an adolescent dose to the schedule and vaccination in pregnancy. Of these, the latter has gained most support.
Vaccination in pregnancy is a strategy which relies on effective transport of antibody across the placenta, a process which depends on the antibody available, the gestation of the pregnancy and the health of the placenta. In the case of pertussis, the main aim is to prevent disease in babies (prior to the age of routine vaccination) as they have a higher mortality than any other age group from pertussis disease.
It is now clear that pertussis vaccination in pregnancy can reduce the burden of disease in young infants in the period prior to them being fully immunised, and can do so safely. However, it is not established whether there is an optimal time to vaccinate in pregnancy to ensure maximal protection of the infant. This is reflected in the different guidelines currently in place in different countries: in the UK vaccination is advised from 16 weeks gestation, in Canada from 26 weeks, in the USA from 27 weeks and in Australia from 28 weeks.
While some studies have suggested that vaccination later in pregnancy can achieve higher antibody concentrations in the newborn, others have found earlier vaccination provides improved immunity compared to later vaccination. The significance of this is that if earlier vaccination is shown to be equivalent, there are clear logistical benefits in allowing the widest possible time window in order to maximise the opportunities for pregnant women to be vaccinated and thereby improve vaccine coverage.
When the pertussis vaccination in pregnancy programmes were first implemented, vaccination was recommended in the third trimester (USA 27-36 weeks, UK 28-32 weeks). This decision was based on the hypothesis that vaccination would be most effective if it was timed to allow the peak in maternal antibody levels after vaccination to coincide with the time of most efficient placental transport.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pertussis specific antibody concentration in cord blood of term infants
时间窗: Delivery of infant
Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) from cord blood of term infants. This will be measured using ELISA.
次要结局
- Pertussis specific antibody concentration in cord blood of preterm infants(Delivery of infant)
- Kinetics of antibody response to pertussis vaccination during pregnancy(Prior to vaccination, 14 days following vaccination, delivery)
- Placental transfer of antibody(Time of delivery)
- Impact of repeated vaccination on antibody response in women who have received a pertussis vaccination in a previous pregnancy(Prior to vaccination, 14 days following vaccination and at delivery)
- Antibody concentration in infants following primary immunisation schedule(28-42 days following completion of primary immunisations)
