Humoral and Cellular Response in Shift Workers

Other Condition That May be a Focus of Clinical Attention Clinical Trial

Official title:

Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528280
• Other study ID #: CEPE2012FRuiz
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: January 9, 2018
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Other Condition That May be a Focus of Clinical Attention

Intervention

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

Locations

Country	Name	City	State
Brazil	Centro de Estudos em Psicobiologia e Exercicio - CEPE	Sao Paulo
Brazil	Centro de Estudos em Psicobiologia e Exercicio _ CEPE	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibodies against hepatitis A virus (anti-HAV)	Change in antibodies against hepatitis A virus (anti-HAV) production	Baseline, 30 days, 60 days and 90 days
Secondary	Intracellular cytokines	Change in intracellular IL-4, IFN-?, IL-2 e TNF-a cytokine levels	Baseline, 30 days, 60 days and 90 days
Secondary	Catecholamines	Change in cathecolamines levels	Baseline, 30 days, 60 days and 90 days
Secondary	Prolactin	Change in prolactin levels	Baseline, 30 days, 60 days and 90 days
Secondary	Growth hormone	Change in growth hormone levels	Baseline, 30 days, 60 days and 90 days
Secondary	Cortisol	Change in cortisol levels	Baseline, 30 days, 60 days and 90 days
Secondary	Sleep disorders	Assessment of sleep disorders	Baseline

External Links

•   Centro de Estudos em Psicobiologia e Exercício
•   Fundação de Amparo à Pesquisa do Estado de São Paulo
•   Psychobiology Department of Federal University of Sao Paulo