Humoral and Cellular Response in Shift Workers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Federal University of São Paulo
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
ClinicalTrials.gov Identifier:
NCT01528280
First received: February 2, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Antibodies against hepatitis A virus (anti-HAV) [ Time Frame: Baseline, 30 days, 60 days and 90 days ] [ Designated as safety issue: No ]
    Change in antibodies against hepatitis A virus (anti-HAV) production


Secondary Outcome Measures:
  • Intracellular cytokines [ Time Frame: Baseline, 30 days, 60 days and 90 days ] [ Designated as safety issue: No ]
    Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels

  • Catecholamines [ Time Frame: Baseline, 30 days, 60 days and 90 days ] [ Designated as safety issue: No ]
    Change in cathecolamines levels

  • Prolactin [ Time Frame: Baseline, 30 days, 60 days and 90 days ] [ Designated as safety issue: No ]
    Change in prolactin levels

  • Growth hormone [ Time Frame: Baseline, 30 days, 60 days and 90 days ] [ Designated as safety issue: No ]
    Change in growth hormone levels

  • Cortisol [ Time Frame: Baseline, 30 days, 60 days and 90 days ] [ Designated as safety issue: No ]
    Change in cortisol levels

  • Sleep disorders [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessment of sleep disorders


Estimated Enrollment: 75
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Shiftwork
The comparision 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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528280

Contacts
Contact: Marco Tulio Mello, PhD +55 11 55720177 tmello@demello.net.br
Contact: Francieli Silva Ruiz, PhD +55 11 55720177 francieli.ruiz@cepebr.org

Locations
Brazil
Centro de Estudos em Psicobiologia e Exercicio _ CEPE Recruiting
Sao Paulo, SP, Brazil, 04020050
Contact: Marco Mello, PhD    551155720177    tmello@demello.net.br   
Centro de Estudos em Psicobiologia e Exercicio - CEPE Not yet recruiting
Sao Paulo, Brazil, 04020050
Contact: Marco Tulio Mello, PhD    +55 11 55720177    tmello@demello.net.br   
Sub-Investigator: Francieli Silva Ruiz, PhD         
Sub-Investigator: Andrea Maculano, Postdoc         
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
  More Information

Additional Information:
No publications provided

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
Study First Received: February 2, 2012
Last Updated: August 11, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Shift work
Hepatitis A vaccination
humoral response
cellular response

ClinicalTrials.gov processed this record on September 16, 2014