On May 6, Atrium Health Levine Children’s is starting a COVID-19 vaccine teen trial for the Novavax vaccine.

News, Child Health | one year ago

Novavax Adolescent Vaccine Clinical Trial Empowers Teens in the Battle Against COVID-19

On May 6, Atrium Health Levine Children’s is starting a COVID-19 vaccine teen trial for the Novavax vaccine. Get answers to your questions about this vaccine trial. And learn how your family can help researchers and doctors continue battling the virus with safety and confidence.

Kids have had every part of their lives disrupted by the pandemic. This includes their activities at home, at school and with friends. Can you think of any part of your child’s routine that hasn’t been affected by COVID-19? Logically, kids should have a chance to be part of the solution after bearing so much of the burden.

As COVID-19 vaccines are being given to adults across the U.S., medical researchers are working to find vaccine options for children. Even as the FDA is considering approvals for the first vaccine for teens, there are still unanswered questions about all COVID-19 vaccines. We need answers to many important questions that affect us all, such as:

  • How long will vaccines work?
  • Will booster shots be needed?
  • What happens if COVID-19 variants develop in the local area?

As we are waiting on studies to answer these questions that are now occurring in adults, we need the same answers for children. To allow children to play an active role in the battle against COVID-19, Novavax and the National Institutes of Health (NIH) have selected Atrium Health Levine Children’s as a site for the COVID-19 vaccine adolescent trial for the Novavax vaccine. The clinical trial is scheduled to start May 6 with enrollment closing May 21.  

“It’s so important for us to understand the way these vaccines work in children so that we can make recommendations safely and confidently,” said Christine Turley, MD, vice chair of research at Levine Children’s and lead physician investigator of the STRIVE program. “Just like adults, children want to move forward and engage in everyday activities again. Many want to be part of finding answers to the vaccine-related questions we are facing every day.”

Dr. Turley addresses common questions about the vaccine trial to help you choose if it’s a good fit for your family and put your mind at ease.

Why is it important to have multiple vaccines for families to consider?

We need to have many vaccine choices available as the pandemic continues to unfold, especially as we try to reach more communities in the U.S. and around the world. We need vaccines that work in different ways so that families have options to consider based on their concerns and preferences. As we have seen with disruptions to the supply chain and pauses based on new findings, we need flexibility in order to fully combat the virus.

How does the Novavax vaccine work?

The Novavax vaccine is a protein-based vaccine. It does not have the live virus in it. It’s the same type of vaccine as the hepatitis B vaccine and the pertussis vaccine. Both of these have been in use for many years. The Novavax vaccine is designed to help your body’s immune response be stronger and to promote stimulate more antibodies. It does not have viral material and cannot replicate in the body. 

Has this vaccine been tested before?

Researchers in the U.S. have been actively studying the Novavax vaccine in adults since last summer.  Four months ago, they started a phase III clinical trial. The vaccine has also been tested in adults in the U.K. in the same way. Interim data from the U.K. trial showed the following:

  • 100% protection against severe disease in about 20,000 adults.
  • 96% final efficacy against mild, moderate and severe disease caused by the original COVID-19 strain.
  • 86% efficacy against the B.1.1.7 variant circulating in the U.K.
  • 90% (about) overall vaccine efficacy.

These trial results are now under review to be licensed as a vaccine in the U.K. 

Why might my teen want to take part?

Many teens have shown an interest in taking part in research and clinical trials and being part of efforts to move beyond COVID-19. The results of this study will impact healthcare for children in our region and around the world. Many teens may want to play a role in finding solutions and contributing to the studies that are essential to a hopeful future beyond COVID-19.

How long will the trial take?

We will follow participants for a total of 2 years. This is to collect complete information about their level of vaccine protection and their immune response over time.

What is involved in the study?

The study will start with several visits over the first 6 weeks. After 6 months, participants will have another series of visits that are not as often. Everyone who takes part will get the study vaccine within the first 6 months.

Over the 2-year study period, there are 7 planned blood tests and 2 nose swabs for COVID-19. Other swabs and blood tests will be needed if participants develop COVID-19 symptoms. We will give numbing medicine for the skin to help lower the pain from the blood tests.  

What are the requirements for taking part?

To be eligible to take part, your child must meet the study requirements. These include:

  • Your child is 12 to 17 years old.
  • Your child has not had COVID-19.
  • Your child does not have any medical conditions that affect their immune response.
  • Your child is not being treated for cancer at this time.

This list does not include everything. We will carefully review the medical history and medicines of any interested teens to see if they qualify to join the study.

How can I enroll my teen in the study? 

Parents or legal guardians can sign up for their teen to be considered for the study using the STRIVE Vaccine Research Registry. (Adults sign up and include information about their children.) There is no commitment involved in joining the registry.

We will call you to review your teen’s eligibility. If you are still interested and your child is eligible, we will schedule an in-person visit to discuss the study and go through the informed consent process in detail. To qualify, both the child and at least 1 parent or legal guardian must be present and agree to participation in the study. 

What if my child doesn’t qualify to take part?

We hope to offer studies to children in other age groups soon. The best way to stay informed about these opportunities is to sign up for the STRIVE Vaccine Research Registry. Based on the information provided, we will reach out to you when we have a study that may be of interest to your family.

What side effects are possible, and how will they be managed?

Like other vaccines, side effects may include headache, fever, body aches, fatigue, arm pain and redness at the injection site. If you have symptoms we will help you find ways to be comfortable. Because this vaccine is still being studied, we don’t know everything that may be possible.

During the study, we’ll ask parents and teens to track symptoms for a week after each vaccine dose. We’ll also be monitoring participants for any unexpected symptoms that occur.

How will Atrium Health ensure my teen’s safety during the trial?

We will only start testing in children after there has been a period of testing in adults to try to find any safety concerns. About 50,000 adults worldwide have been enrolled in studies involving the Novavax vaccine. We start all pediatric studies in older children first. Then, as we establish the safety of a treatment, we start working our way down to younger children slowly and carefully.

Since safety is one of the main goals of the study, we will stay in close contact with families during the entire study. This includes weekly follow-up calls for the first year as well as office visits as needed for any concerns about the vaccine or side effects. We will be monitoring for COVID-19 throughout the study.

Will my teen have to change daily activities or diet during the trial?

No, children in the study do not have to make any changes to their activities or to the food they eat.

Who will pay for this treatment?

There is no cost to take part in the study. In fact, the NIH will give a stipend for participants and families to help cover the time and effort required for the study.

For more information about the STRIVE program, call 833-451-1188.