Humoral and Cellular Response in Shift Workers

Not Applicable

Completed

• Conditions: Other Condition That May be a Focus of Clinical Attention
• Interventions: Biological: Vaccination against hepatitis A; Other: No Intervention

• Registration Number: NCT01528280
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-08
• Study Start: 2013-01
• Primary Completion: 2014-09
• Study Completion: 2016-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shiftwork	Vaccination against hepatitis A	The comparison will consider nightworkers versus dayworkers.
Shiftwork	No Intervention	The comparison will consider nightworkers versus dayworkers.

Primary Outcome Measures

Name	Time	Method
Antibodies against hepatitis A virus (anti-HAV)	Baseline, 30 days, 60 days and 90 days	Change in antibodies against hepatitis A virus (anti-HAV) production

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centro de Estudos em Psicobiologia e Exercicio - CEPE; 🇧🇷 Sao Paulo, Brazil

Centro de Estudos em Psicobiologia e Exercicio _ CEPE; 🇧🇷 Sao Paulo, SP, Brazil