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, half of the babies will receive the ‘whole cell’ pertussis vaccine and the other half will receive the ‘acellular’ pertussis vaccine at two months of age. Subsequent pertussis vaccinations at 4 months and 6 months will be the 'acellular' pertussis vaccine currently given to all babies. 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 in the study will be for 19 months and will include 8 visits to the clinic (at Princess Margaret Hospital and Perth Children's Hospital) starting when your baby is 6-12 weeks old for their first vaccinations.
• Babies will receive all of their routine vaccines at clinic visits up to 19 months of age.
• All babies will be assessed for possible allergies by undergoing a skin prick test at 18 months of age.
• Blood samples will be taken 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 one of the study will involve 150 healthy WA babies starting at 6-12 weeks of age, progressing to 2000 babies in stage two.

Participants MUST be:

• Healthy babies aged 6-12 weeks of age (born ‘term’ after 37 weeks gestation)
• Living in the Perth region

Participants MUST NOT have:

• Serious medical issues
• Diagnosed food allergies or eczema
• 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