PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Prevalence of middle ear disease, defined as middle ear effusion or tympanic membrane perforation or acute otitis media
研究概览
简要总结
PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon after child birth; or c) seven months after child birth (control group). The adult diphtheria, tetanus and acellular pertussis vaccine (dTpa) will be used as the control vaccine for the birth dose.
The study aims to recruit 210 Indigenous women aged 17-39 years who have an uncomplicated pregnancy. Following recruitment, subjects will be randomly assigned to one of the three groups.
Each mother and infant will be followed from pregnancy until the baby is seven months of age. All routinely recommended vaccinations on the standard vaccination schedule will continue to be offered by the subject's vaccine provider in accordance with current clinical practice.
The primary outcome will be prevalence of middle ear disease at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary analyses will be a direct comparison of the proportion of infants in the control group who have nasopharyngeal carriage of one or more vaccine type pneumococci at seven months of age compared to infants in each of the other two groups. A similar comparison of the proportion with middle ear disease will be undertaken between the control group and the respective intervention group.
详细描述
PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants. Two vaccines will be used in this trial:
- The 23 valent pneumococcal polysaccharide vaccine (23vPPV), is currently recommended for all Indigenous people in the Northern Territory from 15 years of age but uptake among women of child-bearing age has been low.
- Adult diphtheria, tetanus and acellular pertussis vaccine (dTPa) will be used as the control vaccine. This vaccine is recommended for all new parents who have not previously been immunised but is not currently funded so would normally need to be purchased on prescription through a pharmacist.
Rationale
Indigenous children experience the highest rates of acute and chronic ear infections in the world, resulting in permanent ear damage, hearing loss and educational disadvantage. These infections are mainly bacterial. Streptococcus pneumoniae (pneumococcus) is the predominant pathogen. Pneumococcal colonisation and infection begins within days of birth, months before any potential immunological protection from infant pneumococcal conjugate vaccine may be expected. New strategies are needed to eliminate, or at least delay, this early-onset pneumococcal colonisation.
Maternal vaccination with the 23 valent pneumococcal polysaccharide vaccine (23vPPV) during pregnancy or at delivery is one strategy that may protect newborn infants through mechanisms such as transplacental antibody transfer, increased secretory antibody in breast milk, and/or by reducing nasopharyngeal carriage (and transmission to the infant) of maternal pneumococci. Previous small studies using this strategy have been encouraging, but there have been no studies properly evaluating nasopharyngeal carriage or disease endpoints in infants.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton uncomplicated pregnancy
- •Reside in Darwin, the Tiwi Islands, or other remote community where consent has been obtained
- •Intends to deliver child at the Royal Darwin Hospital or other designated hospital where consent has been obtained
- •Has given informed consent to participate
排除标准
- •Had 23vPPV within the previous three years
- •Had a previous dose of dTpa
- •Intends to leave the study area during the follow-up period
- •HIV positive
- •History of severe allergy, uncontrolled asthma or splenectomy
结局指标
主要结局
Prevalence of middle ear disease, defined as middle ear effusion or tympanic membrane perforation or acute otitis media
时间窗: at seven months of age
Nasopharyngeal carriage of vaccine type pneumococci
时间窗: at seven months of age
次要结局
- Prevalence of middle ear disease(at two months of age)
- Nasopharyngeal carriage of vaccine type pneumococci(at two months of age)
- Impact of each maternal vaccination strategy on maternal antibody response to antepartum or postpartum 23vPPV(at seven months)
- Impact of each maternal vaccination strategy on breast milk antibody avidity (to four selected serotypes)(at seven months)
- Impact of each maternal vaccination strategy on breast milk antibody levels to serotypes contained in the vaccine(at seven months)
- Impact of each maternal vaccination strategy on infant anti-pneumococcal antibody levels (following the 3rd recommended dose of 7vPCV)(at seven months of age)
- Relationship of maternal pneumococcal carriage, maternal anti-pneumococcal antibody levels, cord blood antibody levels and breast milk antibody levels to infant carriage and middle ear disease(at one, two and seven months of age)
研究者
Ross Andrews
Professor
Menzies School of Health Research