VaccinationSAVINCT07636525
Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study
An observational study of Vaccination, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This study tests whether the sleep habits of 11-12 years-olds impact their response to a vaccine that protects against meningococcal illness. That vaccine is typically given at that age by primary care doctors, but nobody has studied how sleep affects children's response to it. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children aged 11-12.
Who may be able to join
- Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Dean Beebe, Ph.D., 513-636-3489, dean.beebe@cchmc.org
About this study
Official title: Sleep and Adolescent Vaccine Immunogenicity (SAVI) Pilot Study
This study tests whether the sleep habits of 11-12 years-olds impact their response to a vaccine that protects against meningococcal illness. That vaccine is typically given at that age by primary care doctors, but 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.
Families will have their child keep their regular sleep schedule during the 5-week study. 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 for 1 - 1 ½ hours. During the first visit, the child get the vaccine. During the second, they have a blood test.
- Conditions
- Vaccination
- Keywords
- Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post-vaccination
Secondary outcomes (1)
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.
Measured: Each of the 3 days immediately following vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean W Beebe, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636525
- Sponsor's protocol ID
- 2025-0807
- Acronym
- SAVI
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Adolescent Vaccine Immunogenicity (SAVI) Pilot Study
- ClinicalTrials.gov ID
- NCT07636525
- Acronym / sponsor ID
- SAVI / 2025-0807
- Conditions
- Vaccination
- Keywords
- Sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests whether the sleep habits of 11-12 years-olds impact their response to a vaccine that protects against meningococcal illness. That vaccine is typically given at that age by primary care doctors, but 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.
Families will have their child keep their regular sleep schedule during the 5-week study. 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 for 1 - 1 ½ hours. During the first visit, the child get the vaccine. During the second, they have a blood test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children aged 11-12.
Key inclusion criteria (1 listed)
- Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Side Effects
Time frame: Each of the 3 days immediately following vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dean W Beebe, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dean W Beebe, PhD (513-636-3489, dean.beebe@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titers (time frame: 1 month post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.