Yellow Fever Vaccine in Patients With Rheumatic Diseases

April 25, 2019 updated by: University of Sao Paulo General Hospital

Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area

According to World Health Organization (WHO), since December 2016, Brazil is showing a significant increase in cases of yellow fever in humans. In view of this, vaccination is suitable for residents and travelers to the risk area. However, for immunosuppressed patients there is a formal recommendation not to vaccinate with live virus vaccine. On the other hand, the safety and efficacy of the vaccine has been demonstrated in patients with HIV, and safety and seroconversion have also been demonstrated in patients with rheumatic disease who were inadvertently revaccinated for yellow fever. Faced with the impossibility of leaving the high-risk area for some patients the vaccination could be released to only those who have low level of immunosuppression as suggested by some recommendations of medical societies. The availability of a fractional vaccine in the State of São Paulo, which has proved its efficacy, opens the possibility of exposure to a lower number of copies of the virus in the first exposure of immunosuppressed patients, allowing, if necessary, a safer revaccination, after 28 days to obtain of a more effective immunogenic response. The objectives of the study are to evaluate the immune response of the immunization with fractional yellow fever vaccine (neutralizing antibodies) in patients with systemic autoimmune rheumatic diseases residing in a high-risk area. Secondarily, evaluate the possible association between immunogenicity and vaccination with: demographic data, clinical and laboratory activity of the disease in patients with chronic rheumatic diseases, evaluate the curve of viremia and report adverse events. Patients and healthy controls will be vaccinated for yellow fever in the Immunization Center of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP). The patients' screening for exclusion and inclusion criteria will be done at the rheumatology outpatient clinic after medical evaluation. For the controls will be the routine screening of the Immunization Center. The vaccination protocol will be a fractional dose of the yellow fever vaccine on day D0 for both groups. Patients will be evaluated on day D0, D5, D10, D30-4 and D365 and controls only on days D0, D10, D30-45 and D365 for aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelets, urea and creatinine, immunoglobulin M (IgM) by immunofluorescence for Yellow Fever, viremia, autoantibodies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatic disease under low immunosuppression (hydroxychloroquine, sulfasalazine or methotrexate plus prednisone up to 7,5mg/day or leflunomide plus prednisone up to 7,5mg/day),
  • Resident in high risk área for Yellow Fever

Exclusion Criteria:

  • Active disease
  • Primary immunodeficiency
  • History of anaphylactic response to vaccine components or egg allergy
  • Living outside the risk area
  • Do not meet criteria for low immunosuppression
  • History of previous immunization with the yellow fever vaccine
  • History of live virus vaccine up to 4 weeks before
  • Individuals who do not agree to participate in the study and/or whose parents do not agree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rheumatic diseases patients
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
Biological: Yellow Fever vaccine (17D)
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
Active Comparator: Healthy controls
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
Biological: Yellow Fever vaccine (17D)
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine
Time Frame: 10 days
Comparison of adverse events rates (based on the Brighton Collaboration diagnostic criteria) between rheumatic disease patients and healthy controls after Yellow Fever vaccine
10 days
Number of participants with protective levels of antibodies against Yellow Fever vaccine
Time Frame: 30 days
Comparison of protective antibodies rates (measured by indirect immunofluorescence) against Yellow Fever virus between rheumatic disease patients and healthy controls after Yellow Fever vaccine
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases
Time Frame: 30 days
Association of number of patients with protective antibodies levels against yellow fever and disease activity in patients with chronic rheumatic diseases (measured by systemic lupus erythematosus disease activity index-SLEDAI for systemic lupus erythematosus patients, disease activity score-DAS28 for rheumatoid arthritis patients, manual muscle testing-MMT and disease activity score-DAS for inflammatory myopathies patients, Birmingham Vasculitis Activity Score-BVAS for primary vasculitis patients, juvenile arthritis disease activity score-JADAS for juvenile idiopathic arthritis patients)
30 days
Number of participants with persistent protective levels of antibodies against Yellow Fever
Time Frame: 1 year
Comparison of protective antibodies rates (measured by indirect immunofluorescence) against Yellow Fever virus between rheumatic disease patients and healthy controls after Yellow Fever vaccine
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Eloisa Bonfa, MD, PhD, Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP - Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

March 24, 2018

Study Completion (Actual)

February 24, 2019

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VFAReumatoHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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