Sleep Clinical Trial
— MAVRICSOfficial title:
Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes
Verified date | October 2023 |
Source | Walter Reed National Military Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - Age 18-64 - Eligible to receive flu vaccination (at military hospital, DEERS eligible) Exclusion Criteria: - Allergy or contraindication to getting flu vaccine - Pregnancy or likelihood of getting pregnant in next few weeks - Medical history of doctor diagnosed immune-compromising condition (HIV/AIDS, cancer, diabetes, significant cardiovascular disease) or doctor diagnosed sleep disorder (insomnia, narcolepsy).*Sleep apnea is an exclusion unless stable on treatment with cpap or oral device for more than3 months. - Currently taking any immune suppressants or immunomodulating treatments (systemic corticosteroids, chemotherapy, etc, within the past 3 months) or sleep medication or supplement (including over the counter medications and melatonin, within the past 1 month). |
Country | Name | City | State |
---|---|---|---|
United States | Naval Support Activity | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Walter Reed National Military Medical Center | Naval Medical Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-influenza antibody titers | Seroconversion and titer >=1:40 post-vaccination | 14-21 days post vaccination | |
Primary | Cell-mediated immunity | ELISpot (secretion of Interferon-gamma and Granzyme B with restimulation by influenza viral antigens), Flow cytometry to determine CD4+ and CD8+ T cell producing IFN(g) with influenza viral restimulation, and Luminex multiplex cytokine analysis in cell culture supernatant of PBMC after restimulation with influenza viral antigens. | 14-21 days post vaccination | |
Secondary | Sleep survey - Pittsburgh Sleep Quality Index (PSQI) | PSQI and vaccine immunogenicity (primary outcomes) | 14-21 days post vaccination | |
Secondary | Actigraph data | Correlation of actigraph data and vaccine immunogenicity (primary outcomes) | 14-21 days post vaccination | |
Secondary | Chronotype survey - Munich ChronoType Questionaire (MCTQ) | Correlation of MCTQ score with vaccine immunity | 14-21 days post vaccination |
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