Completed

NCT Number: NCT01528280

Humoral and Cellular Response in Shift Workers

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.

Completed

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Key information

Conditions

Other Condition That May be a Focus of Clinical Attention

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Estudos em Psicobiologia e Exercicio _ CEPE, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaccination against hepatitis A

Biological

Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.

No intervention

Other

No Intervention

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2016
First posted: Feb 8, 2012
Registry last updated: Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.