Clinical Trial: PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease

Study Status: Recruiting
Recruit Status: Unknown status
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 18-39 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. Children will receive all of their routinely recommended vaccinations in accordance with the standard vaccination schedule.

The primary outcome will be prevalence of ear infection 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 vaccine type pneumococci at seven months of age compared to infants in each of the other two groups and a similar comparison of the proportion with middle ear disease.


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: University of Melbourne

Current Primary Outcome:

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


Original Primary Outcome:

  • Prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media
  • Nasopharyngeal carriage of vaccine type pneumococci at seven months of age


Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: University of Melbourne

Dates:
Date Received: March 31, 2006
Date Started: March 2006
Date Completion: January 2009
Last Updated: December 12, 2007
Last Verified: March 2006