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NCT Number: NCT07636525

Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational 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.

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Key information

Conditions

Age range

11 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Dean Beebe, Ph.D.

CONTACT

[email protected]

513-636-3489

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Antibody titers

    Time frame: 1 month post-vaccination

    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

  1. Side Effects

    Time frame: Each of the 3 days immediately following vaccination.

    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

  1. Sleep

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dean W Beebe, PhD

CONTACT

[email protected]

513-636-3489

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Sleep and Adolescent Vaccine Immunogenicity (SAVI) Pilot Study

Acronym: SAVI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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