Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study (SAVI)

Sleep and Adolescent Vaccine Immunogenicity (SAVI) Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Vaccination

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Dean W Beebe, PhD; Phone Number: 513-636-3489; Email: dean.beebe@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Dean Beebe, Ph.D.; Phone Number: 513-636-3489; Email: dean.beebe@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy children aged 11-12.

Description

Inclusion Criteria:

• Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.

Exclusion Criteria:

• 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
• Use of a medication that impacts sleep
• Average nightly sleep of 8-8.99 hours (between the two groups)
• Daily intake of >1 coffee or "energy drink" or >2 caffeinated sodas.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Short Sleepers; Children who regularly sleep <8 hours/night on both weekends and weekdays
Healthy Sleepers; Children who regularly sleep at least 9 hours/night on both weekends and weekdays

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Each of the 3 days immediately following vaccination.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Daily for weeks 1 and 2, then again for week 4 (immediately before the final visit).

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Dean W Beebe, Ph.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sleep
• Other Study ID Numbers: 2025-0807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No