What is Strep A?

Strep A bacteria are often responsible for mild infections, such as pharyngitis, also known as sore throat or strep throat, and impetigo commonly referred to as skin sores or school sores.

If left untreated, Strep A can lead to severe diseases which can cause heart and kidney failure. Rheumatic heart disease is one of these more severe diseases. Strep A infections can become life-threatening very quickly if the bacteria invade the body's blood stream, muscles or lungs. In Australia. Strep A infections more commonly affect Aboriginal and Torres Strait Islander people.

Why do we need a vaccine against Strep A Pharyngitis?

Strep A infections are a major cause of illness and death throughout the world each year. This study is an important step towards creating a vaccine against sore throats caused by Strep A, so that we can prevent other, more serious diseases caused by the bacteria.

Mild disease

• Pharyngitis (sore throat): 615 million cases per year globally
• Impetigo (skin sores): 162 million active cases globally

Severe disease

• Heart Disease: 34 million cases globally, 340,000 deaths per year
• Kidney Disease: 470,000 cases per year globally

Invasive disease

• 660,000 cases per year globally, 160,000 deaths per year

Who is conducting the study?

The Sore Throat Study is being carried out by the Australian Strep A Vaccine Initiative (ASAVI), an Australian-led global initiative with the goal of reducing the disease burden caused by Group A Streptococcus (Strep A) infection through effective vaccination.

ASAVI is a collaboration between Perth’s Telethon Kids Institute and Melbourne’s Murdoch Children’s Research Institute (MCRI).

Does this study have ethics approval?

The Sore Throat Study has been approved by the Ethics Committee of Perth Children’s Hospital/Child and Adolescent Health Service and has Governance Authorisation at the Melbourne Children’s Campus, incorporating The Royal Children’s Hospital Melbourne and Murdoch Children’s Research Institute.

What will researchers investigate?

Taking part in the Sore Throat Study will help researchers learn more about:

• how many children get sore throats
• what is the most common cause of sore throat in children
• how sore throats can change during different seasons of the year
• how a vaccine could be used to prevent sore throats caused by Strep A bacteria

Who can take part?

Healthy children and young people aged 3 to 14 years of age will be invited to participate in this study.

The Sore Throats Study - what does the study involve?

Baseline Visit

Your child’s first visit will take place at one of our study sites, which are located at the Perth Children’s Hospital, Perth, and the Royal Children’s Hospital, Melbourne. At this visit we will collect important personal and health information from you and your child. You will have a one-on-one appointment with our study team who will explain the study, and answer any and all questions you may have. If you are happy to participate in the study, we will ask you to give you consent by signing the study’s information and consent form. We will collect some body fluid samples from your child to complete the visit. These will include throat swabs, as well as a blood sample and skin swab if needed.

Seasonal Check-ups

The nature of sore throats, like the flu and other illnesses, is that they can change in severity and numbers of cases throughout the year depending on the season. For this reason, the Sore Throat Study will conduct seasonal check-ups at the turn of each season. These visits will be similar to the baseline visit, but will include a skin examination for any painful or itchy ‘skin sores’ that can be caused by Strep A bacteria.

Tracking your symptoms

During the Sore Throat Study, a weekly text message will be sent to your phone. If they do, you’ll complete a brief survey about their symptoms and be asked to visit your GP for a sore throat check-up. Your GP will use our rapid-diagnosis technology to diagnose your child’s sore throat within minutes, and provide you with the best treatment for your child’s sore throat. If needed, they will also take some throat swabs and a blood sample. 5 days following a GP visit, we will send you a follow up survey to ask how your child is recovering from their episode of their sore throat, and arrange a follow-up appointment with your study team.