An interventional study of Yellow Fever vaccine (17D) in Systemic Lupus, Rheumatoid Arthritis and Spondyloarthritis, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 2 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Prevention
Among 26 studies in Sjogren's Syndrome with a site in Brazil — 5 open to participants now, 12 under way, 7 of them phase 3. Sjogren's Syndrome · Brazil.
Among the 26 studies in Sjogren's Syndrome with a site in Brazil, this one is the 8th largest by enrollment of the 25 interventional ones, is one of 3 that started in 2018, is one of 7 with no phase, and was the 5th registered.
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's enrollment of 600 is above the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →5 of the 26 studies in Sjogren's Syndrome with a site in Brazil are open now, in 12 countries. Each count lists the studies.
Of the 67 Sjogren's Syndrome studies recruiting now, 26 (39%) set no upper age limit and 25 (37%) stop at 75 or younger; 9 take children under 18; 11 take healthy volunteers.
This study: 2 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 3 started in 2018.
Median enrollment 275 across the 25 interventional studies, 74 across the 1 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
13 of 26 have an industry lead sponsor. The 10 most frequent:
University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
University of Sao Paulo General Hospital has 8 studies filed under Sjogren's Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Sjogren's Syndrome with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05946941Phase 3Bristol-Myers SquibbA Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome | 2026-11-18 |
Among the 26 studies in Sjogren's Syndrome with a site in Brazil, from their registry updates:
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.
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's enrollment of 600 is above the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Sjogren's Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arthritis, Rheumatoid. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: Yellow Fever vaccine (17D)
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine
Comparison of adverse events rates (based on the Brighton Collaboration diagnostic criteria) between rheumatic disease patients and healthy controls after Yellow Fever vaccine
Time frame: 10 days
Number of participants with protective levels of antibodies against Yellow Fever vaccine
Comparison of protective antibodies rates (measured by indirect immunofluorescence) against Yellow Fever virus between rheumatic disease patients and healthy controls after Yellow Fever vaccine
Time frame: 30 days
Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases
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)
Time frame: 30 days
Number of participants with persistent protective levels of antibodies against Yellow Fever
Comparison of protective antibodies rates (measured by indirect immunofluorescence) against Yellow Fever virus between rheumatic disease patients and healthy controls after Yellow Fever vaccine
Time frame: 1 year
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Mar 2018, 1 month.
Of 39 non-industry interventional studies with no phase under Sjogren's Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 1 month is below that.
Counting every sponsor, half of 44 studies reached it within 18 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Yellow Fever Vaccine
University of Sao Paulo General Hospital →