Melatonin and Vaccine Response, Immunity, and Chronobiology Study

NCT04953754 | Unknown DMC FDA Device

• 1 other identifier: NMRC.2021.0006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaccine Response; Sleep; Circadian Rhythm Disorders

Keywords

Sleep; Circadian health; Vaccine immunogenicity; Melatonin

Outcome Measures

Primary Outcomes (2)

• Anti-influenza antibody titers

  Seroconversion and titer \>=1:40 post-vaccination

  14-21 days post vaccination

• 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 Outcomes (3)

• Sleep survey - Pittsburgh Sleep Quality Index (PSQI)

  14-21 days post vaccination

• Actigraph data

  14-21 days post vaccination

• Chronotype survey - Munich ChronoType Questionaire (MCTQ)

  14-21 days post vaccination

Study Arms (2)

Melatonin Group

EXPERIMENTAL

This group will get melatonin 5mg nightly

Dietary Supplement: Melatonin; Device: Phillips Actiwatch Spectrum Plus

Control Group

ACTIVE COMPARATOR

This group will not get any treatment (melatonin)

Device: Phillips Actiwatch Spectrum Plus

Interventions

Melatonin DIETARY_SUPPLEMENT

The melatonin group will receive 5mg melatonin nightly

Melatonin Group

Phillips Actiwatch Spectrum Plus DEVICE

Both groups will be monitored by the FDA-cleared Actigraph

Control Group; Melatonin Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-64
• Eligible to receive flu vaccination (at military hospital, DEERS eligible)

You may not qualify if:

• Allergy or contraindication to getting flu vaccine
• Pregnancy or likelihood of getting pregnant in next few weeks
• 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).

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Naval Medical Research Center: collaborator

Study Sites (1)

Naval Support Activity

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Chronobiology Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Janine Danko, MD

  Naval Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Service Chief, Allergy, Immunology & Immunizations

Model Details: Prospective open label melatonin compared to control

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: July 8, 2021
• Study Start: October 25, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

US (1)