Immunogenicity and safety of high-dose versus standard-dose inactivated influenza vaccine in rheumatoid arthritis patients: a randomised, double-blind, active-comparator trial

2020 ◽  
Vol 2 (1) ◽  
pp. e14-e23 ◽  
Author(s):  
Inés Colmegna ◽  
Mariana L Useche ◽  
Katherine Rodriguez ◽  
Deirdre McCormack ◽  
Giuliana Alfonso ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Influenza Vaccine ◽  
Standard Dose ◽  
High Dose ◽  
Double Blind ◽  
Active Comparator ◽  
Comparator Trial

Randomized, double-blind comparison of standard-dose vs. high-dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients

2014 ◽  
Vol 19 (2) ◽  
pp. 219-228 ◽  
Author(s):  
Sarah GiaQuinta ◽  
Marian G. Michaels ◽  
Jonathan A. McCullers ◽  
Li Wang ◽  
Christopher Fonnesbeck ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Standard Dose ◽  
Organ Transplant ◽  
Solid Organ Transplant ◽  
High Dose ◽  
Solid Organ ◽  
Double Blind ◽  
Transplant Patients ◽  
Blind Comparison

scholarly journals A Double-Blind, Randomized Trial of High-Dose vs Standard-Dose Influenza Vaccine in Adult Solid-Organ Transplant Recipients

2017 ◽  
Vol 66 (11) ◽  
pp. 1698-1704 ◽  
Author(s):  
Yoichiro Natori ◽  
Mika Shiotsuka ◽  
Jaclyn Slomovic ◽  
Katja Hoschler ◽  
Victor Ferreira ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Randomized Trial ◽  
Standard Dose ◽  
Organ Transplant ◽  
Solid Organ Transplant ◽  
High Dose ◽  
Solid Organ ◽  
Transplant Recipients ◽  
Double Blind ◽  
Solid Organ Transplant Recipients

scholarly journals Randomized, Double‐Blind Controlled Phase 3 Trial Comparing the Immunogenicity of High‐Dose and Standard‐Dose Influenza Vaccine in Adults 65 Years of Age and Older

2009 ◽  
Vol 200 (2) ◽  
pp. 172-180 ◽  
Author(s):  
Ann R. Falsey ◽  
John J. Treanor ◽  
Nadia Tornieporth ◽  
Jose Capellan ◽  
Geoffrey J. Gorse
Keyword(s):  
Influenza Vaccine ◽  
Standard Dose ◽  
High Dose ◽  
Phase 3 ◽  
Double Blind

scholarly journals Gastrointestinal Events in High-Dose vs Standard-Dose Influenza Vaccine Recipients

2018 ◽  
Vol 5 (6) ◽  
Author(s):  
H Keipp Talbot ◽  
Andrew J Dunning ◽  
Corwin A Robertson ◽  
Victoria A Landolfi ◽  
David P Greenberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Randomized Clinical Trial ◽  
Standard Dose ◽  
High Dose ◽  
Passive Surveillance ◽  
Prospective Randomized Clinical Trial ◽  
Gastrointestinal Events ◽  
Gastrointestinal Adverse Events

Abstract Passive surveillance data had signaled the possibility of gastrointestinal adverse events occurring after the administration of high-dose inactivated influenza vaccine (IIV-HD). However, in a large, prospective randomized clinical trial, rates of serious gastrointestinal events were no greater among IIV-HD recipients than among those who received a standard-dose influenza vaccine.

scholarly journals Immunogenicity of high-dose influenza vaccination in patients with primary central nervous system malignancy

2018 ◽  
Vol 5 (3) ◽  
pp. 176-183
Author(s):  
Roy E Strowd ◽  
Gregory Russell ◽  
Fang-Chi Hsu ◽  
Annette F Carter ◽  
Michael Chan ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Influenza Vaccine ◽  
Elderly Patients ◽  
Influenza Vaccination ◽  
Standard Dose ◽  
High Grade Glioma ◽  
Cns Lymphoma ◽  
High Dose ◽  
Central Nervous System Malignancy

Abstract Background For cancer patients, rates of influenza-associated hospitalization and death are 4 times greater than that of the general population. Previously, we reported reduced immunogenicity to the standard-dose influenza vaccine in patients with central nervous system malignancy. In other poorly responding populations (eg, elderly patients), high-dose vaccination has improved efficacy and immunogenicity. Methods A prospective cohort study was designed to evaluate the immunogenicity of the Fluzone® high-dose influenza vaccine in brain tumor patients. Data on diagnosis, active oncologic treatment, and immunologic status (eg, CD4 count, CD8 count, CD4:CD8 ratio) were collected. All patients received the high-dose vaccine (180 µg). Hemagglutination inhibition titers were measured at baseline, day 28, and 3 months following vaccination to determine seroconversion (≥4-fold rise) and seroprotection (titer ≥1:40), which were compared to our prior results. Results Twenty-seven patients enrolled. Diagnoses included high-grade glioma (85%), CNS lymphoma (11%), and meningioma (4%). Treatment at enrollment included glucocorticoids (n = 8, 30%), radiation (n = 2, 7%), and chemotherapy (n = 9, 33%). Posttreatment lymphopenia (PTL, CD4 ≤ 200) was observed in 4 patients (15%). High-dose vaccination was well tolerated with no grade III-IV toxicity. Overall, seroconversion rates for the A/H1N1, A/H3N2, and B vaccine strains were significantly higher than in our prior study: 65% vs 37%, 69% vs 23%, and 50% vs 23%, respectively (all P < .04). Seroconversion was universally poor in patients with PTL. While seroprotection at 3 months declined in our prior study, no drop was observed following high-dose vaccination in this cohort. Conclusions The immunologic response to HD influenza vaccination was higher in this cohort than standard-dose influenza vaccination in our prior report. These findings mirror those in elderly patients where high-dose vaccination is the standard of care and raise the possibility of an immunosenescence phenotype.

scholarly journals Efficacy and safety of levilimab, a monoclonal antibody to interleukin-6 receptors, in patients with rheumatoid arthritis

2021 ◽  
Vol 31 (4) ◽  
pp. 36-43
Author(s):  
P. Novikov ◽  
E. Shchegoleva ◽  
S. Moiseev
Keyword(s):  
Rheumatoid Arthritis ◽  
Monoclonal Antibody ◽  
Joint Disease ◽  
High Dose ◽  
Dosing Regimen ◽  
Double Blind ◽  
Low Disease Activity ◽  
Membrane Bound ◽  
Systemic Manifestations ◽  
Favorable Safety

Interleukin (IL)-6 is a proinlammatory cytokine contributing significantly to the pathogenesis of joint disease and systemic manifestations of rheumatoid arthritis (RA). Levilimab is a new original monoclonal antibody that blocks both soluble and membrane-bound IL-6 receptors. Efficacy and favorable safety profile of levilimab in combination with methotrexate were shown in two randomized double-blind placebo-controlled trials (AURORA and SOLAR) that included patients with active RA despite treatment with methotrexate alone. Both primary and multiple secondary efficacy endpoints including ACR response, low disease activity or remission rates, changes in RA activity scores, etc, confirmed a higher efficacy of levilimab compared to placebo. Profile of adverse events was typical for IL-inhibitors. Several observational studies suggested that unlike rituximab or medium or high dose glucocorticoids IL-6 receptors inhibitors do not worsen outcomes of COVID19 and do not impair immunogenicity of vaccines against COVID-19. Therefore, patients treated with levilimab should not delay vaccination or modify the dosing regimen prior to vaccination.

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