PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers

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.

Timeline

Start

2006-06

Primary completion

2011-02

Completion

2011-07

Outcome

Missed primary endpoint

paper unable to demonstrate efficacy of 23vPPV in pregnancy against the co-primary outcomes PMID 26529076 ↗

Publications

• Martinovich KM, Seppanen EJ, Bleakley AS, Clark SL, Andrews RM, Richmond PC, Binks MJ, Thornton RB, Kirkham LS. Evidence of maternal transfer of antigen-specific antibodies in serum and breast milk to infants at high-risk of S. pneumoniae and H. influenzae disease. Front Immunol. 2022 Sep 21;13:1005344. doi: 10.3389/fimmu.2022.1005344. eCollection 2022.
• Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Nelson J, Morris PS, Ware RS, Tang MLK, Torzillo PJ, Carapetis JR, Mulholland K, Andrews RM. Impact of the 23-valent pneumococcal polysaccharide vaccination in pregnancy against infant acute lower respiratory infections in the Northern Territory of Australia. Pneumonia (Nathan). 2018 Dec 25;10:13. doi: 10.1186/s41479-018-0057-2. eCollection 2018.
• Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Morris PS, Nelson J, Chatfield MD, Tang ML, Torzillo P, Carapetis JR, Mulholland EK, Andrews RM. PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia. Vaccine. 2015 Nov 27;33(48):6579-87. doi: 10.1016/j.vaccine.2015.10.101. Epub 2015 Oct 31.

Drugs

Indications