Sore Throat Study

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.

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

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 The Kids Research Institute Australia (The Kids) and Melbourne’s Murdoch Children’s Research Institute (MCRI).

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 and at the Women’s and Children’s Health Network, Adelaide.

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

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

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, and the Royal Children’s Hospital, Melbourne, the Women’s and Children’s Hospital, Adelaide, your child’s GP practice or in your home. 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 your 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 a throat swab and blood sample, which can be taken from your child’s vein or via a fingerprick.

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 two seasonal check-ups. These visits will be similar to the baseline visit.

Sore Throat Visit

If you child has had a sore throat we’ll ask you to complete a brief survey about their symptoms and arrange a visit with the study team to collect information and a throat swab. If your child experiences a sore throat which is severe, we will encourage you to make an appointment with your child’s usual GP, as well. The study team will also arrange a recovery check-up visit following an episode of sore throat, to collect some additional samples and information if necessary.