Vaccination against SARS-CoV-2

Babies taking part in AVAnT1A are given three vaccines: the first by the age of six months, the second three to six weeks later, and the third after another eight weeks have passed. The COVID-19 vaccine used is safe and approved by the NHS for children aged six months and older.

AVAnT1A uses what is known as a randomized, placebo-controlled study design. This means that participating babies are randomly assigned to one of two groups. All of the babies in one group (the intervention group) receive the vaccine against SARS-CoV-2.  All of the babies in the other group receive a 'dummy' vaccination (called a placebo) - this is a safe injection that looks the same as the COVID-19 vaccine but has no active ingredients. The researchers, the study personnel, and the families will not know which group a child belongs to until the study is completed.

Collection of Saliva and Stool samples

Since many infections in young children occur almost without symptoms, participating families are asked to collect saliva (weekly) and stool samples (monthly) from their children. From these samples, researchers can see which viruses the children had contact with.

Regular Physical Examination

During the study, the families are asked to attend a clinic for regular physical examinations of their baby.  This includes measuring height and weight as well as taking small blood samples. In the first phase of the study, a physical examination is done every three months up until the baby is two years old, then every six months, and then after the third birthday it is once per year. Children are invited to examinations up until their sixth birthday. Our study team (see below) can answer any questions parents have about diabetes and their child's well-being during visits. If a child shows signs of developing Type 1 diabetes, this can be detected early.  This means families can get the best support and information available to support their child.

E-Diary entries

During the study parents are asked to complete a simple eDiary every couple of weeks.

Expenses

Appointments for physical examinations and blood tests take place in either the Royal Victoria Infirmary (Newcastle upon Tyne) or Cambridge University Hospital (East of England) .  Parents are reimbursed for all costs associated with travel and parking for these visits.  In recognition of the time taken to collect samples and complete diaries, parents are also offered reimbursement for their time up to £500 (dependent on the number of samples returned/diary entries completed).

Children with an increased genetic risk for developing type 1 diabetes are invited to participate in the AVAnT1A Study. Their increased risk is detected within the newborn screening called the INGR1D2 study, which in England is offered selected hospitals in the North East North Cumbria and the East of England (see here for a list of participating hospitals). Newborns are tested using a blood collected as part of the blood spot test routinely offered in the NHS. 

Families can participate in the AVAnT1A study if:

• their baby is not older than 4 months AND

• their baby has been identified as being at higher genetic risk for type 1 diabetes as part of the INGR1D2 study 

If you would like more detailed information about what AVAnT1A is and what is involved then please look at our Participant Information Sheets .  These are the documents we provide to everyone who takes part in AVAnT1A.  There are two versions; a short version which gives an overview of the study, and then a much longer version which includes lots more detail.   If you have questions and would like to speak to a member of the AVAnT1A team, please see below for contact details.