Humoral and Cellular Response in Shift Workers
This study is not yet open for participant recruitment.
Verified February 2012 by Federal University of São Paulo
Sponsor:
Federal University of São Paulo
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
AFIP: Associação Fundo de Incentivo à Pesquisa
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: February 3, 2012
Last verified: February 2012
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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 |
| 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: | March 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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
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 | 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
AFIP: Associação Fundo de Incentivo à Pesquisa
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: | February 3, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Shift work Hepatitis A vaccination humoral response cellular response |
Additional relevant MeSH terms:
|
Hepatitis A Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013