Humoral and Cellular Response in Shift Workers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to access whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment.

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Detailed Description

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Sleep regulates immune functions. In this sense, we asked whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment. Men (18 to 55 years) will be recruited through different forms of media (electronic, newspapers, radio and magazines). The shift workers sleep pattern will be recorded polysomnographically. Subsequently, the volunteers will be underwent vaccination against hepatitis A (2 doses) and after 30, 60 and 90 days, blood samples will be collected to assess the humoral response in the experimental groups. The hormones prolactin, growth hormone, cortisol, adrenaline and noradrenaline will also be evaluated. Indeed, stimulations in culture will be conducted to assess the cellular response profile against the vaccination through the production assessment of IL-4, IFN-γ, IL-2 and TNF-α.

Conditions

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Other Condition That May be a Focus of Clinical Attention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Shiftwork

The comparison will consider nightworkers versus dayworkers.

Group Type EXPERIMENTAL

Vaccination against hepatitis A

Intervention Type BIOLOGICAL

Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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Vaccination against hepatitis A

Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.

Intervention Type BIOLOGICAL

No Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* shift workers
* naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL

Exclusion Criteria

* smokers
* individuals with complaints and/or sleep disorders
* acute or chronic disease
* use of medication during the study period.
* acute illnesses

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes