We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Humoral and Cellular Response in Shift Workers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Marco Tulio de Mello, Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528280
First Posted: February 8, 2012
Last Update Posted: August 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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: Intervention Model: Single Group Assignment
Masking: None (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 Marco Tulio de Mello, 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 ]
    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 ]
    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 ]
    Change in cathecolamines levels

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

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

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

  • Sleep disorders [ Time Frame: Baseline ]
    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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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


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:
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 Submitted: February 2, 2012
First Posted: February 8, 2012
Last Update Posted: August 12, 2014
Last Verified: August 2014

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