Clinical trial Recruiting at 1 site Observational Ages 11 to 12

Sleep and Teens’ Immune Response to a Meningococcal Vaccine

Official title: Sleep and Adolescent Vaccine Immunogenicity (SAVI) Pilot Study

Run by Children's Hospital Medical Center, Cincinnati · NCT07636525 · Data updated 2026-11-12

This study checks if 11- to 12-year-olds’ sleep habits affect how well their vaccine for meningococcal disease works.

Quick facts

Study typeObservational
Ages11 Years to 12 Years
SexAll
Enrollment66 (estimated)
SponsorChildren's Hospital Medical Center, Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedJuly 1, 2026
Main results expectedJuly 2027
Study endsJuly 2027
Registry record updatedOctober 19, 2026
Trial IDNCT07636525 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy 11–12-year-olds who have not yet received the initial meningococcal vaccination and have no conditions or treatments causing immunosuppression.

Probably not a fit

Individuals with sleep disorders, significant sleep deprivation, or other factors that impair immune response may not experience clearer vaccine benefits in this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study monitors sleep patterns and vaccine response in healthy early teens receiving a meningococcal vaccine. Participants wear a sleep tracker and complete daily online diaries over five weeks, with two in-person visits for vaccination and a blood test. Sleep schedule consistency is encouraged, and results will be correlated with antibody responses to the vaccine. The study is conducted at Cincinnati Children’s Hospital Medical Center and led by the hospital, with no listed collaborators.

Why it matters

Potential benefit: If successful, the findings could inform recommendations on sleep optimization to potentially improve vaccine responses in adolescents.

How similar studies have gone: Some adult studies suggest sleep can influence immune responses, but pediatric data are limited and this approach is relatively novel in this age group.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting

Study contacts

  • Principal investigator: Dean W Beebe, Ph.D. — Children's Hospital Medical Center, Cincinnati
  • Study coordinator: Dean W Beebe, PhD
  • Email: dean.beebe@cchmc.org
  • Phone: 513-636-3489

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.