The Sore Throat Study is looking for healthy children and young people to take part in a new study investigating sore throats, also known as pharyngitis, and how best to prevent them.
The Sore Throat Study is an important first step towards a vaccine against sore throats caused by the bacteria Strep A, also known as ‘Strep’ or ‘Strep Throat’ and other serious diseases like rheumatic heart disease.
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.
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 Throat Study - what does the study involve?
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, 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.
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.
Can my child withdraw from the project?
If you give your consent and later change your mind, that’s ok. You can stop your and your child’s involvement in the study at any time.
The Sore Throat Study will follow your child for 12 months. The information collected will provide researchers with the necessary information needed to proceed with Strep A vaccine trials in both Melbourne and Perth.
How to get involved?
If you would like more information about this study, or would like to participate, you can contact our team using the details listed below, or you can talk to your GP directly.
Thank you for taking the time to learn about the Sore Throat Study and the important work being done to develop a vaccine for Strep A. We hope to hear from you soon!