About this trial
The main reason for this research study is to understand whether the sleep habits of 11-12 years-olds impact their response to a vaccine. The vaccine is called MCV4. It protects against meningococcal illness, which is rare but can be severe. The American Academy of Pediatrics recommends that the vaccine be given at age 11 or 12. The vaccine has been approved for youth in this age range for over 20 years and is one of the vaccines that primary care doctors typically give around this age. However, nobody has studied how sleep affects children's response to it. This could be important because research on adults suggests that sleep affects the immune system. We want to look at that issue in a younger age range.
Participating families will be asked to have their child keep their regular sleep schedule during the 5-week study, without much variation. During that time, they will wear a special wristwatch at night to track their sleep. Each day they will fill out a short online form. They and a parent/guardian will come to Cincinnati Children's twice. Each visit will last 1 - 1 ½ hours. The first visit will happen at the end of the 1st week. The second is at the end of the 5th week. During visits, they will fill out forms and we will get data from the wristwatch. During the first visit, the participating child would get the vaccine. During the second, they will have a blood test.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.
Disqualifiers
Condition or treatment resulting in immunosuppression
Prior severe vaccine reaction
Symptoms of clinical insomnia or organic sleep disorder
Known neurologic condition or intellectual/developmental disability
Trial population
Healthy children aged 11-12.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Antibody titers
Measured via serum bactericidal assay (SBA), which measures the ability of serum antibodies to kill the meningococcus bacteria in the presence of complement protein. The primary outcome will be the proportion of individuals in each group with a titer greater than or equal to 1:8 for each MCV4 serotype (A, C, W, Y), which is a strong correlate of protection.
Secondary outcomes
Side Effects
Each morning, secure online survey links will be sent via text message or email to the youth, parent or both. Youth will be asked to rate online the 8 most common side effects of meningococcal vaccination (e.g., injection site pain, headache) on a 5-point scale from not present to severe. A printed survey and phone number will be provided for call-in ratings if online entry fails.
Other outcomes
Sleep
Sleep (adherence) will be objectively measured during remote monitoring via wristwatch-like devices, checked for artifacts against self-reported sleep on a daily diary. The primary adherence measure will be sleep duration (onset to offset). Secondarily, sleep quality will be defined as the percent of time from onset to offset spent asleep.
Sponsors and contacts
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