Clinical Trial: PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease

Brief Summary:

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.


Detailed Summary:

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
Sponsor: Menzies School of Health Research

Current Primary Outcome:

  • Prevalence of middle ear disease, defined as middle ear effusion or tympanic membrane perforation or acute otitis media [ Time Frame: at seven months of age ]
  • Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at seven months of age ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prevalence of middle ear disease [ Time Frame: at one month of age ]
  • Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at one month of age ]
  • Prevalence of middle ear disease [ Time Frame: at two months of age ]
  • Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at two 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 [ Time Frame: at one, two and seven months of age ]
  • Impact of each maternal vaccination strategy on breast milk antibody levels to serotypes contained in the vaccine [ Time Frame: at seven months ]
  • Impact of each maternal vaccination strategy on breast milk antibody avidity (to four selected serotypes) [ Time Frame: at seven months ]
  • Impact of each maternal vaccination strategy on maternal antibody response to antepartum or postpartum 23vPPV [ Time Frame: at seven months ]
  • Impact of each maternal vaccination strategy on infant anti-pneumococcal antibody levels (following the 3rd recommended dose of 7vPCV) [ Time Frame: at seven months of age ]


Original Secondary Outcome: Same as current

Information By: Menzies School of Health Research

Dates:
Date Received: July 10, 2008
Date Started: June 2006
Date Completion:
Last Updated: July 9, 2014
Last Verified: July 2014