Melatonin and Vaccine Response, Immunity, and Chronobiology Study

Sleep Clinical Trial

— MAVRICS  

Official title:

Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04953754
• Other study ID #: NMRC.2021.0006
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

Description:

Vaccination is critical to public health and disease prevention. However, despite the many scientific advancements and vaccines on the market, they are not always fully effective. Adjuvants are often used to boost immunity, but they are associated with more side effects, possible allergic reactions and public mistrust that supports vaccine hesitancy. Many factors affect vaccine efficacy and host immunity. Sleep, circadian health and melatonin have been studied in the past to affect immune response to vaccines and infection. Patient education about better sleep habits and/or melatonin use are potentially safe, cost effective, and accessible interventions that may improve host immunity and vaccine effectiveness. However, neither have been studied rigorously and at this time, are not actively implemented in the clinical arena. Hence, we propose a study comparing vaccine immunogenicity based on sleep quality, chronotype, and exogenous melatonin.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Sleep
• Vaccine Response

Intervention

Dietary Supplement:
• Melatonin
The melatonin group will receive 5mg melatonin nightly

Device:
• Phillips Actiwatch Spectrum Plus
Both groups will be monitored by the FDA-cleared Actigraph

Locations

Country	Name	City	State
United States	Naval Support Activity	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	Naval Medical Research Center

Country where clinical trial is conducted

United States, 

Outcome

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