TAMPA, Fla — USF Health Morsani College of Medicine has been selected as a site for the clinical trial testing of the Moderna nRNA-1273 COVID-19 vaccine for children between the ages of 6 months and 11 years old.
Moderna intends to enroll up to 12,000 pediatric participants in the United States and Canada in this Phase 2/3 research study called KidCOVE study, USF Health said in a news release.
USF Health research physicians are seeking Tampa Bay area volunteers to participate in the KidCOVE study to evaluate the safety and immune responses. Enrollment begins for USF Health in the coming days.
"USF Health is pleased to join this national clinical trial to determine the safety and effectiveness of Moderna vaccines in children and younger populations," Charles Lockwood, MD, senior vice president of USF Health and dean of the USF Health Morsani College of Medicine, said. "Widespread vaccination is the best defense against COVID-19, and this rigorous scientific study may go a long way toward increasing vaccine access in this younger demographic."
Leading the USF Health effort as principal investigator is Carina Rodriguez, MD, professor and chief of the Division of Pediatric Infectious Diseases in the Department of Pediatrics in the USF Health Morsani College of Medicine.
Rodriguez is hopeful that the research will help curb the pandemic.
"This research study can help provide critical information about the safety, reactogenicity and immune responses observed with the vaccine in children and ultimately allow the vaccine to be approved for children," Dr. Rodriguez said. "A vaccine that prevents COVID-19 disease in children would be a crucial public health tool to help curb the pandemic."
Children who participate in the study will be seen by the study team based in USF Health's Department of Pediatrics. Three out of four children participating in part 2 of the KidCOVE clinical trial will receive two intramuscular injections of the vaccine spaced at four weeks apart, USF Health says.
The vaccine is made of messenger ribonucleic acid (mRNA), an instructional code that tells cells how to make protein, which help the body’s immune system make antibodies to fight the virus. The remaining quarter of participants will receive injections of a placebo made of saline (sterile saltwater) solution.
All participants will be randomly selected to receive the vaccine or placebo. Participants will be followed for 12 months post-vaccination to monitor their health and safety.
Who's eligible?
Study volunteers must be:
- Between 6 months and 11 years old
- In good health or with stable chronic conditions
You are not eligible if:
- Have received an investigational or approved vaccine for COVID-19
- Be currently taking any investigational or approved treatments for COVID-19
- Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to vaccine administration
- Have participated in any clinical trial in the past month
Those who wish to enroll their children in the study can email usfchildrenscovidvaccine@gmail.com or call or text 813-853-1149.
Prior to this study, children between the ages of 12 and 15 were able to start receiving the Pfizer vaccine back in May.
