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Humoral and Cellular Response in Shift Workers

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ClinicalTrials.gov Identifier: NCT01528280
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marco Tulio de Mello, 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.

Condition or disease Intervention/treatment
Other Condition That May be a Focus of Clinical Attention Biological: Vaccination against hepatitis A Other: No Intervention

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response
Study Start Date : January 2013
Primary Completion Date : September 2014
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Shiftwork
The comparison will consider nightworkers versus dayworkers.
Biological: 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.
Other: No Intervention
No Intervention



Primary Outcome Measures :
  1. Antibodies against hepatitis A virus (anti-HAV) [ Time Frame: Baseline, 30 days, 60 days and 90 days ]
    Change in antibodies against hepatitis A virus (anti-HAV) production


Secondary Outcome Measures :
  1. Intracellular cytokines [ Time Frame: Baseline, 30 days, 60 days and 90 days ]
    Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels

  2. Catecholamines [ Time Frame: Baseline, 30 days, 60 days and 90 days ]
    Change in cathecolamines levels

  3. Prolactin [ Time Frame: Baseline, 30 days, 60 days and 90 days ]
    Change in prolactin levels

  4. Growth hormone [ Time Frame: Baseline, 30 days, 60 days and 90 days ]
    Change in growth hormone levels

  5. Cortisol [ Time Frame: Baseline, 30 days, 60 days and 90 days ]
    Change in cortisol levels

  6. Sleep disorders [ Time Frame: Baseline ]
    Assessment of sleep disorders



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528280


Locations
Brazil
Centro de Estudos em Psicobiologia e Exercicio _ CEPE
Sao Paulo, SP, Brazil, 04020050
Centro de Estudos em Psicobiologia e Exercicio - CEPE
Sao Paulo, Brazil, 04020050
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Marco Tulio Mello, Associate Professor Federal University of Sao Paulo
Study Chair: Francieli Silva Ruiz, PhD Federal University of Sao Paulo
Study Chair: Andrea Maculano, PhD Federal University of Sao Paulo

Additional Information:
Responsible Party: Marco Tulio de Mello, Associate Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01528280     History of Changes
Other Study ID Numbers: CEPE2012FRuiz
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Marco Tulio de Mello, Federal University of São Paulo:
Shift work
Hepatitis A vaccination
humoral response
cellular response

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs