IMPAACT I2021 (RSV Vaccination in Young Children) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if 2 different experimental vaccines can provide safe and effective protection against RSV infection in young children. This study is important because there is not an FDA-approved vaccine to help prevent RSV in children.

What is the Condition Being Studied?

Vaccination Against Respiratory Syncytial Virus (RSV)

Who Can Participate in the Study?

Children ages 6-25 months who:
- Are healthy
- Have never had RSV
- Do not go to daycare with other children who are 4 months old or younger

For more information about who can be in this study, please contact the study team at lori.hendrickson@duke.

What is Involved?

The study is divided into 3 periods: a screening period, a vaccination period, and a follow-up period.

If you and your child choose to join the study, you will go through a screening period to see if your child is eligible. During this period, you and your child will:
- Come to our clinic for a 1-2 hour visit
- Have a physical exam (child)
- Have blood drawn (child)

If we think your child may be eligible to participate, we will schedule your child for a vaccination visit. During this visit, your child will:
- Test for COVID-19 and confirm they have not been exposed to COVID-19 for 14 days before this visit
- Have a physical exam
- Be randomly assigned (like flipping a coin) to 1 of 2 groups
-- One group will get 1 of the 2 study vaccines
-- The other group will get a placebo vaccine (inactive substance)
- Wait in our clinic for 30 minutes after getting the vaccine or placebo to be observed by the study team

The study vaccines are given as a droplet into your child's nose. We will ask you to take your child's temperature every day for 28 days after they get the study vaccine. We will call you each day during this period to record their temperature and see how they're feeling.

When 28 days have passed since vaccination, the follow-up period will begin. During this period, you will:
- Have visits with the study team either in-person or by telephone for up to a year
- Come to our clinic with your child after the end of RSV season so your child can have a small blood draw

You and your child will be compensated for your time on the study.

Study Details

Full Title
Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ?NS2/?1313/I1314L, RSV 6120/?NS2/1030s or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
Principal Investigator
Protocol Number
IRB: PRO00109199
Phase
Phase I/II
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698