Clinical trial NCT01528280: Humoral and Cellular Response in Shift Workers
Official title: Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Condition That May be a Focus of Clinical Attention
Keywords: Shift work
Hepatitis A vaccination
humoral response
cellular response
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-02-08
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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

Primary outcomes:
measure: Antibodies against hepatitis A virus (anti-HAV)
timeFrame: Baseline, 30 days, 60 days and 90 days
Secondary outcomes:
measure: Intracellular cytokines
timeFrame: Baseline, 30 days, 60 days and 90 days
measure: Catecholamines
timeFrame: Baseline, 30 days, 60 days and 90 days
measure: Prolactin
timeFrame: Baseline, 30 days, 60 days and 90 days
measure: Growth hormone
timeFrame: Baseline, 30 days, 60 days and 90 days
measure: Cortisol
timeFrame: Baseline, 30 days, 60 days and 90 days
measure: Sleep disorders
timeFrame: Baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Estudos em Psicobiologia e Exercicio _ CEPE
state: SP
city: Sao Paulo
country: Brazil
facility: Centro de Estudos em Psicobiologia e Exercicio - CEPE
Study officials:
affiliation: Federal University of São Paulo
name: Marco Tulio Mello, Associate Professor
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Francieli Silva Ruiz, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Andrea Maculano, PhD
role: STUDY_CHAIR
References: