- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07636525
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Dean W Beebe, PhD
- Telefonnummer: 513-636-3489
- E-mail: dean.beebe@cchmc.org
Studiesteder
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Rekruttering
- Cincinnati Children's Hospital Medical Center
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Kontakt:
- Dean Beebe, Ph.D.
- Telefonnummer: 513-636-3489
- E-mail: dean.beebe@cchmc.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Short Sleepers
Children who regularly sleep <8 hours/night on both weekends and weekdays
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Healthy Sleepers
Children who regularly sleep at least 9 hours/night on both weekends and weekdays
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antibody titers
Tidsramme: 1 month post-vaccination
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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.
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1 month post-vaccination
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Side Effects
Tidsramme: Each of the 3 days immediately following vaccination.
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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.
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Each of the 3 days immediately following vaccination.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sleep
Tidsramme: Daily for weeks 1 and 2, then again for week 4 (immediately before the final visit).
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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.
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Daily for weeks 1 and 2, then again for week 4 (immediately before the final visit).
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Dean W Beebe, Ph.D., Children's Hospital Medical Center, Cincinnati
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2025-0807
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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