OPTIMUM Study

What is the OPTIMUM Study about?

The number of children suffering from food allergies appears to have risen greatly in the last 20 years. Serious allergic reactions can be life-threatening and statistics show up to 3 in every 10 Australian children develop 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 prevent allergy by training the immune system to recognise the difference between germs that are harmful and things that are not harmful, like food. By training the immune system in this way, there is potential to prevent allergic responses to harmless substances.

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 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 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.
• Two blood samples will be taken at 18 and 19 months of age. This allows researchers to better understand how immune responses to vaccination protect against whooping cough and possibly predispose to, or protect, against allergic diseases like food allergy, asthma and eczema.

Who can participate?

Stage two of 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 call us on: 0400 450 240 or email us at OPTIMUM@telethonkids.org.au