Humoral and Cellular Response in Shift Workers

Study Overview
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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.

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.

Official Title
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Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response

Conditions
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Other Condition That May be a Focus of Clinical Attention

Intervention / Treatment
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* Biological: Vaccination against hepatitis A
* Other: No Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shiftwork<br>The comparison will consider nightworkers versus dayworkers. | Biological: Vaccination against hepatitis A<br>* Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.<br>Other: No Intervention<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibodies against hepatitis A virus (anti-HAV) | Change in antibodies against hepatitis A virus (anti-HAV) production | Baseline, 30 days, 60 days and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracellular cytokines | Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels | Baseline, 30 days, 60 days and 90 days | 
| Catecholamines | Change in cathecolamines levels | Baseline, 30 days, 60 days and 90 days | 
| Prolactin | Change in prolactin levels | Baseline, 30 days, 60 days and 90 days | 
| Growth hormone | Change in growth hormone levels | Baseline, 30 days, 60 days and 90 days | 
| Cortisol | Change in cortisol levels | Baseline, 30 days, 60 days and 90 days | 
| Sleep disorders | Assessment of sleep disorders | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shift work, Hepatitis A vaccination, humoral response, cellular response