Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07636525
Status
Recruiting
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Conditions

  • Vaccination

Eligibility Criteria

Sex
ALL
Age
11 Years - 12 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
66 participants (estimated)

Arms

  • Arm: Short Sleepers
    Children who regularly sleep \<8 hours/night on both weekends and weekdays
  • Arm: Healthy Sleepers
    Children who regularly sleep at least 9 hours/night on both weekends and weekdays

Primary Outcome Measure

Antibody titers [ Time Frame: 1 month post-vaccination ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Dean Beebe, Ph.D.
[email protected]
513-636-3489

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