Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study

NCT07636525 | Recruiting

• 1 other identifier: 2025-0807
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccination

Keywords

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Side Effects

  Each of the 3 days immediately following vaccination.

Other Outcomes (1)

• Sleep

  Daily for weeks 1 and 2, then again for week 4 (immediately before the final visit).

Study Arms (2)

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

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children aged 11-12.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Study Officials

• Dean W Beebe, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean W Beebe, PhD

CONTACT

513-636-3489; dean.beebe@cchmc.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)