ProVac:Probiotic adjuvant to enhance the efficacy of pnemococcal vaccination: A pilot study.
A randomised double blind, placebo-controlled trial to evaluate the efficacy of a probiotic adjuvant in enhancing vaccine immune responses in healthy infants aged 3-7 months.
Associate Professor Mimi Tang
30 participants
Apr 16, 2013
Interventional
Conditions
Summary
This pilot study aims to develop a new approach to improve protection against pneumococcal disease, using a probiotic (Bifidobacterium Bi-07) to boost immune responses to and reduce invasion by the pneumococcal bacteria. We are particularly interested in whether Bifidobacterium lactis Bi-07 given early in life, together with vaccination, can improve protection against pneumococcal infection and therefore reduce disease. This study will involve 30 babies and the use of Bifidobacterium lactis Bi-07 is currently experimental.
Eligibility
Inclusion Criteria4
- Healthy, term infants (post-delivery) will be recruited from the postnatal maternity ward at the Royal Women's Hospital, Melbourne.
- )The infant must be 4 weeks of age.
- The infant must be born via a vaginal birth at 37 weeks or greater gestation.
- The mother cannot have been on antibiotic treatment 2 weeks prior to delivery.
Exclusion Criteria7
- Mothers who were taking probiotics during pregnancy or are on probiotic supplements.
- Mothers who have a proven or suspected immunodeficiency.
- Infants must not have had a probiotic.
- Infants who have a significant foetal abnormality.
- Infants who have or a proven or suspected immunodeficiency.
- Significant maternal illness or disability such that study participation would impose an unacceptable additional burden.
- Planning or likely to leave the area before the study finishes.
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Interventions
To evaluate the adjuvant effect of B.lactis Bi-07 on the immune response to pneumococcal conjugate (PCV13) vaccination in healthy infants. The probiotic powder is freeze-dried Bifidobacterium Bi-07 and silicon dioxide.The probiotic will be mixed with 10mls of cooled boiled water and administered orally via a syringe. Packaged in 1.0 gram white sachets, 100 per carton. The probiotic will be administered once daily. Once infants have been recruited, the study period will be 6 months from the first day of treatment (at 4 weeks of age) until 7 months of age which spans the 3-dose PCV13 schedule (at 2,4,6 months). Compliance to the probiotic treatment will be monitored by a study diary that will completed by the parents/guardians on a daily basis. As this is a pilot study, we will also be able to determine feasibility of compliance during the study period and develop appropriate strategies to maintain this.
Locations(1)
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ACTRN12613000368730