The Children’s Hospital Research Institute of Manitoba (CHRIM) is part of an international research study called KidCOVE, which is being conducted by Moderna. The primary purpose of KidCOVE is to test the safety and effectiveness of the study vaccine, called mRNA-1273, that may protect children between the ages of 6 months to under 12 years of age from getting sick if they come into contact with SARS-CoV-2, which causes COVID-19.
The coronavirus (COVID-19) pandemic is like nothing we’ve seen in more than a century, and it has altered each and every one of our lives. Parents and caregivers are waiting on a vaccine so children can return to school, the playground, and afterschool activities. And now, children right here in Manitoba will be part of important research on a COVID-19 vaccine that is bringing us one step closer to ending this global health crisis.
CHRIM Investigator, Dr. Sergio Fanella, an Associate Professor and Program Director for Pediatric Infectious Diseases at the University of Manitoba is leading the KidCOVE study based in the Research Support Unit at CHRIM.
“I’m ecstatic that we have this trial here in Manitoba,” said Dr. Sergio Fanella. “Families of kids in the study should be proud of the young participants” he went on to say. “They’re doing something not only for themselves but something that benefits their extended family, their grandparents, their friends, their neighbours, their local community, and also the global population”.
Participants will be enrolled for 14 months and will include telephone and in-person visits at CHRIM.
The children are being given two injections in the upper arm about 28 days apart with each participant having a three to one chance to receive either the mRNA-1273 study vaccine or the placebo. By using a placebo, medical researchers can understand if the study vaccine is effective in preventing COVID-19. Dosage amounts are one fourth of the adult dosage amount and all participants will be told if they had the vaccine or placebo as soon as any vaccine is approved for their age group.
Participants will also be asked to use an eDiary app on a smartphone to report any COVID-19 symptoms the child experiences. Each child will be closely monitored by the study team if any symptoms of COVID-19 are reported at any time throughout their participation.
CHRIM Researcher, Dr. Lauren Kelly, and mother of two, was excited to enroll her son in the clinical trial once participants could join.
“Vaccinating young children will protect them from potentially life-long consequences following a COVID-19 infection and help all of us get back to life before the pandemic,” shared Dr. Kelly, Assistant Professor in the Departments of Pediatrics and Child Health and Community Health Sciences at the University of Manitoba. “Participating in this clinical trial was the only way for him (three-year-old son) to potentially access a vaccine at this time. I know that whether he got the vaccine or the placebo, the data generated from this study will be used to support the approval of vaccines for all children under five. Bonus, my toddler is very excited that people want to learn about his body.”
Due to the overwhelming interest from parents and caregivers that wanted to get their children involved in this clinical trial, researchers are no longer accepting new participants at this time. The Research Support Unit is currently working through a waitlist of potential participants which speaks to the incredible researchers and doctors we have at the research institute and the trust that families place in them.
The KidCove study is one of 78 active research studies happening within the Research Support Unit. Of these studies, 22 are clinical trials with three of those being related to COVID-19.