Vaccine ResponseMAVRICSNCT04953754
Melatonin and Vaccine Response, Immunity, and Chronobiology Study
A study testing Melatonin and Phillips Actiwatch Spectrum Plus in people with Vaccine Response and Sleep, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Response, Sleep, Circadian Rhythm Disorders
- What is being tested?
- Melatonin and Phillips Actiwatch Spectrum Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-64
- Eligible to receive flu vaccination (at military hospital, DEERS eligible)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes
This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.
Read the detailed 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.
- Conditions
- Vaccine Response, Sleep, Circadian Rhythm Disorders
- Being tested
- Melatonin, Phillips Actiwatch Spectrum Plus
- Keywords
- Sleep, Circadian health, Vaccine immunogenicity, Melatonin
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
The melatonin group will receive 5mg melatonin nightly
Phillips Actiwatch Spectrum PlusDevice
Both groups will be monitored by the FDA-cleared Actigraph
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Group | Experimental | This group will get melatonin 5mg nightly Receives: Dietary Supplement: Melatonin; Device: Phillips Actiwatch Spectrum Plus |
| Control Group | Active comparator | This group will not get any treatment (melatonin) Receives: Device: Phillips Actiwatch Spectrum Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-influenza antibody titers
Seroconversion and titer >=1:40 post-vaccination
Measured: 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.
Measured: 14-21 days post vaccination
Secondary outcomes (3)
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)
PSQI and vaccine immunogenicity (primary outcomes)
Measured: 14-21 days post vaccination
Actigraph data
Correlation of actigraph data and vaccine immunogenicity (primary outcomes)
Measured: 14-21 days post vaccination
Chronotype survey - Munich ChronoType Questionaire (MCTQ)
Correlation of MCTQ score with vaccine immunity
Measured: 14-21 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start25 Oct 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ResponseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective open label melatonin compared to control
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Naval Medical Research Center
- Responsible party
- Principal investigator, Rachel Lee, Walter Reed National Military Medical Center
- Investigators
- Janine Danko, MD, Principal investigator, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953754
- Sponsor's protocol ID
- NMRC.2021.0006
- Acronym
- MAVRICS
- Status last verified
- Oct 2023
- First submitted
- 4 Jun 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes
- ClinicalTrials.gov ID
- NCT04953754
- Acronym / sponsor ID
- MAVRICS / NMRC.2021.0006
- Conditions
- Vaccine Response, Sleep, Circadian Rhythm Disorders
- Keywords
- Sleep, Circadian health, Vaccine immunogenicity, Melatonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Naval Medical Research Center
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Jul 2021 (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 will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective open label melatonin compared to control
| Arm | Type | Receives |
|---|---|---|
| Melatonin Group | Experimental | Dietary Supplement: Melatonin, Device: Phillips Actiwatch Spectrum PlusThis group will get melatonin 5mg nightly |
| Control Group | Active comparator | Device: Phillips Actiwatch Spectrum PlusThis group will not get any treatment (melatonin) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-64
- Eligible to receive flu vaccination (at military hospital, DEERS eligible)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninThe melatonin group will receive 5mg melatonin nightly | Dietary supplement | Melatonin Group |
| Phillips Actiwatch Spectrum PlusBoth groups will be monitored by the FDA-cleared Actigraph | Device | Control Group, Melatonin Group |
Primary outcome
Anti-influenza antibody titers
Time frame: 14-21 days post vaccination
Seroconversion and titer >=1:40 post-vaccination
Cell-mediated immunity
Time frame: 14-21 days post vaccination
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.
3 secondary outcomes
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)
Time frame: 14-21 days post vaccination
Actigraph data
Time frame: 14-21 days post vaccination
Chronotype survey - Munich ChronoType Questionaire (MCTQ)
Time frame: 14-21 days post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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. This study is not recruiting at the moment.
Janine Danko, MD principal investigator
Naval Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Phillips Actiwatch Spectrum Plus in people with Vaccine Response and Sleep, run by Walter Reed National Military Medical Center 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-influenza antibody titers (time frame: 14-21 days post vaccination). The study lists 2 primary outcomes in all. 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 10 Oct 2023.