NCT01528280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

February 2, 2012

Last Update Submit

January 9, 2018

Conditions

Other Condition That May be a Focus of Clinical Attention

Keywords

Shift workHepatitis A vaccinationhumoral responsecellular response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Intracellular cytokines

    Baseline, 30 days, 60 days and 90 days

  • Catecholamines

    Baseline, 30 days, 60 days and 90 days

  • Prolactin

    Baseline, 30 days, 60 days and 90 days

  • Growth hormone

    Baseline, 30 days, 60 days and 90 days

  • Cortisol

    Baseline, 30 days, 60 days and 90 days

  • +1 more secondary outcomes

Study Arms (1)

Shiftwork

EXPERIMENTAL

The comparison will consider nightworkers versus dayworkers.

Biological: Vaccination against hepatitis AOther: No Intervention

Interventions

Vaccination against hepatitis ABIOLOGICAL

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

Shiftwork
No InterventionOTHER

No Intervention

Shiftwork

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • shift workers
  • naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL

You may not qualify if:

  • smokers
  • individuals with complaints and/or sleep disorders
  • acute or chronic disease
  • use of medication during the study period.
  • acute illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Estudos em Psicobiologia e Exercicio _ CEPE

São Paulo, São Paulo, 04020050, Brazil

Location

Centro de Estudos em Psicobiologia e Exercicio - CEPE

São Paulo, 04020050, Brazil

Location

Related Links

Study Officials

  • Marco Tulio Mello, Associate Professor

    Federal University of São Paulo

    STUDY DIRECTOR

  • Francieli Silva Ruiz, PhD

    Federal University of São Paulo

    STUDY CHAIR

  • Andrea Maculano, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 8, 2012

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2016

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations

BR(2)