Research Opportunity: OPTIMUM Study
What is the OPTIMUM Study?
The number of children suffering from food allergies appears to have risen greatly in the last 20 years with 3 in every 10 Australian children developing either a food-related allergy or eczema.
Vaccines work by training the immune system to recognise what certain germs look like. Researchers believe some vaccines might also help to prevent allergy by making the immune system less likely to react to things that are not harmful, like food.
The OPTIMUM study is looking to determine whether one dose of 'whole cell' pertussis (whooping cough) vaccine given at two months of age instead of the current 'acellular' pertussis vaccine can help protect young children against allergic outcomes.
What happens in the study?
In the OPTIMUM Study, babies will be randomly assigned to receive either one dose of whole cell whooping cough vaccine at two months of age, followed by two doses of acellular vaccine, or just have the usual schedule of three doses of the acellular whooping cough vaccine.
Participants in the study will be followed up until they are around 18 or 19 months old to try and find out if babies who received the 'whole cell' vaccine are less likely to develop allergic conditions such as food allergy or eczema.
- Participation will be for 19 months and will include three or four visits to the study clinic, starting when your baby receives their first vaccinations at 6-12 weeks of age.
- All babies will be assessed for possible allergies by undergoing a skin prick test at 12 months of age. If children are found to have a reaction to the skin prick test they may undergo an oral food challenge to confirm any possible food allergy
Who is eligible?
The OPTIMUM Study will involve 3000 babies from across Australia. Study clinics are located in Perth, Sydney and Melbourne.
Participants MUST be:
- Healthy babies aged 6-12 weeks of age (born after 32 weeks gestation)
Participants MUST NOT have:
- Serious medical issues
- Diagnosed food allergies
- Received their 6-8 week vaccines
If you are currently pregnant or have recently had a baby and are interested in being involved, then please contact your nearest study centre:
Phone 0400 450 240
Phone 0403 292 554
This study has been approved by the Child and Adolescent Health Service Human Research Ethics Committee and is sponsored by the University of Sydney