CCTSI plays major role in vaccine clinical trials for children

As Colorado surpasses a 47 percent rate of its population being fully immunized (with 12 counties surpassing 70 percent), researchers continue to expand the study of the vaccines on children as young as five years old. The Pediatric Clinical and Translational Research Center (CTRC) and its nursing staff are playing a major role.Clinical Program Manager Lisa Lewis, BSN, RN has been preparing for the Pfizer BioNTech COVID-19 vaccine trial since March 1. The trial officially kicked off on June 7. “We will dedicate three of our CTRC nurses a day for this trial and Children’s Hospital Colorado recruited two additional nurses,” says Lewis. Over the course of this two-year-long study, nurses will be conducting the blood draws, nasal swabs and doing nasal swab education.

Eric Simões, MD, DCH is the Principal Investigator (PI) for the study at Children’s Hospital Colorado, which is one of the 80 locations that are part of the trial across the country. Children’s Colorado is also the largest site, with 250 volunteers; every other site will average about 25 participants.

Lewis has worked with Children’s Colorado CTRC for 18 years and is excited to launch the first clinical trial of COVID-19 vaccine at Children’s Hospital Colorado. She notes that the study will provide clinical data on the effect of the vaccine on the youngest school-age children, which makes it particularly important. This study involves children from ages 5 to less than 12.

Colorado parents were eager to involve their children, with more than 4,400 registering in an initial database. From this group, 250 were enrolled.

“One of the goals for this clinical trial was to make sure we have a very ethnically diverse patient population. When we shared our ethnicity enrollment data, we saw that it matched the state of Colorado for its ethnicity ratios,” Lewis says.

All children who volunteer for the study will receive either the Pfizer vaccine or a placebo. “Two-thirds of the participants will receive the vaccine and one-third will receive the placebo,” Lewis says. “We will give the children their first and second dose of the vaccine or a placebo three weeks apart. Then when the participants return for a follow-up visit, we will conduct nasal swabs, educate children on the nasal swabs and we will also test their levels of antibodies in their blood.”

No one will know if the child received the vaccine or a placebo until the six-month visit. That is when the “unblinding” will occur.  After their six-month visit, any child who received a placebo will be eligible to receive the actual vaccine.

Participants will be enrolled in this trial for two years to determine how the vaccines work in protecting children from COVID-19 over the long term.

This major undertaking of a clinical trial is a fitting capstone to Lewis’ career in research nursing. As of July 2, she will be leaving the CTRC for a career change, taking a position as a nurse consultant. She says, “This has been an excellent place to work. Eighteen years of working with great nurses and with our CCTSI and CTRC leadership--there are a lot of great memories.”