Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Patients with Juvenile Autoimmune Rheumatic Disease

2011 ◽  
Vol 39 (1) ◽  
pp. 167-173 ◽  
Author(s):  
NADIA E. AIKAWA ◽  
LUCIA M.A. CAMPOS ◽  
CLOVIS A. SILVA ◽  
JOZELIO F. CARVALHO ◽  
CARLA G.S. SAAD ◽  
...  
Keyword(s):  
Rheumatic Disease ◽  
Influenza A ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Healthy Controls ◽  
Seroprotection Rate ◽  
H1n1 Vaccine ◽  
Link Type ◽  
Autoimmune Rheumatic Disease ◽  
Influenza A H1n1

Objective.To assess the immunogenicity and safety of non-adjuvanted influenza A H1N1/2009 vaccine in patients with juvenile autoimmune rheumatic disease (ARD) and healthy controls, because data are limited to the adult rheumatologic population.Methods.A total of 237 patients with juvenile ARD [juvenile systemic lupus erythematosus (JSLE), juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), juvenile scleroderma, and vasculitis] and 91 healthy controls were vaccinated. Serology for anti-H1N1 was performed by hemagglutination inhibition assay. Seroprotection rate, seroconversion rate, and factor-increase in geometric mean titer (GMT) were calculated. Adverse events were evaluated.Results.Age was comparable in patients and controls (14.8 ± 3.0 vs 14.6 ± 3.7 years, respectively; p = 0.47). Three weeks after immunization, seroprotection rate (81.4% vs 95.6%; p = 0.0007), seroconversion rate (74.3 vs 95.6%; p < 0.0001), and the factor-increase in GMT (12.9 vs 20.3; p = 0.012) were significantly lower in patients with juvenile ARD versus controls. Subgroup analysis revealed reduced seroconversion rates in JSLE (p < 0.0001), JIA (p = 0.008), JDM (p = 0.025), and vasculitis (p = 0.017). Seroprotection (p < 0.0001) and GMT (p < 0.0001) were decreased only in JSLE. Glucocorticoid use and lymphopenia were associated with lower seroconversion rates (60.4 vs 82.9%; p = 0.0001; and 55.6 vs 77.2%; p = 0.012). Multivariate logistic regression including diseases, lymphopenia, glucocorticoid, and immunosuppressants demonstrated that only glucocorticoid use (p = 0.012) remained significant.Conclusion.This is the largest study to demonstrate a reduced but adequate immune response to H1N1 vaccine in patients with juvenile ARD. It identified current glucocorticoid use as the major factor for decreased antibody production. The short-term safety results support its routine recommendation for patients with juvenile ARD. ClinicalTrials.gov; NCT01151644.

Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases

2011 ◽  
Vol 70 (6) ◽  
pp. 1068-1073 ◽  
Author(s):  
Carla G S Saad ◽  
Eduardo F Borba ◽  
Nadia E Aikawa ◽  
Clovis A Silva ◽  
Rosa M R Pereira ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Influenza A ◽  
Geometric Mean ◽  
Vaccine Safety ◽  
Primary Antiphospholipid Syndrome ◽  
H1n1 Vaccine ◽  
Link Type ◽  
Autoimmune Rheumatic Disease ◽  
Influenza A H1n1 ◽  
2009 H1n1

BackgroundDespite the WHO recommendation that the 2010–2011 trivalent seasonal flu vaccine must contain A/California/7/2009/H1N1-like virus there is no consistent data regarding its immunogenicity and safety in a large autoimmune rheumatic disease (ARD) population.Methods1668 ARD patients (systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic sclerosis, psoriatic arthritis (PsA), Behçet's disease (BD), mixed connective tissue disease, primary antiphospholipid syndrome (PAPS), dermatomyositis (DM), primary Sjögren's syndrome, Takayasu's arteritis, polymyositis and Granulomatosis with polyangiitis (Wegener's) (GPA)) and 234 healthy controls were vaccinated with a non-adjuvanted influenza A/California/7/2009(H1N1) virus-like strain flu. Subjects were evaluated before vaccination and 21 days post-vaccination. The percentage of seroprotection, seroconversion and the factor increase in geometric mean titre (GMT) were calculated.ResultsAfter immunisation, seroprotection rates (68.5% vs 82.9% p<0.0001), seroconversion rates (63.4% vs 76.9%, p<0.001) and the factor increase in GMT (8.9 vs 13.2 p<0.0001) were significantly lower in ARD than controls. Analysis of specific diseases revealed that seroprotection significantly reduced in SLE (p<0.0001), RA (p<0.0001), PsA (p=0.0006), AS (p=0.04), BD (p=0.04) and DM (p=0.04) patients than controls. The seroconversion rates in SLE (p<0.0001), RA (p<0.0001) and PsA (p=0.0006) patients and the increase in GMTs in SLE (p<0.0001), RA (p<0.0001) and PsA (p<0.0001) patients were also reduced compared with controls. Moderate and severe side effects were not reported.ConclusionsThe novel recognition of a diverse vaccine immunogenicity profile in distinct ARDs supports the notion that a booster dose may be recommended for diseases with suboptimal immune responses. This large study also settles the issue of vaccine safety.(ClinicalTrials.gov #NCT01151644)

scholarly journals Immunogenicity Associated with the Routine Use of an Influenza A H1N1 Vaccine in Health Care Personnel in Guangzhou, China

2010 ◽  
Vol 17 (9) ◽  
pp. 1478-1480 ◽  
Author(s):  
Biao Di ◽  
Xinhong Xu ◽  
Tiegang Li ◽  
Enjie Lu ◽  
Jibin Wu ◽  
...  
Keyword(s):  
Health Care ◽  
Influenza A ◽  
Vaccination Campaign ◽  
Negative Control ◽  
Health Care Personnel ◽  
Seroprotection Rate ◽  
H1n1 Vaccine ◽  
Influenza A H1n1 ◽  
2009 H1n1 ◽  
Antibody Levels

ABSTRACT We present immunogenicity data on the routine vaccination of 103 health care personnel during the 2009 H1N1 national vaccination campaign. The seroprotection rate (percentage of samples with hemagglutination inhibition titers of ≥1:40) was 83.2% at 30 days postvaccination, lower than those obtained in previously published controlled trials. Low baseline antibody levels and an increase in seroprotection in a negative-control cohort suggest that the virus remains prevalent.

scholarly journals Prospective Cohort Study of the Safety of an Influenza A(H1N1) Vaccine in Pregnant Chinese Women

2014 ◽  
Vol 21 (9) ◽  
pp. 1282-1287 ◽  
Author(s):  
Fubao Ma ◽  
Longhua Zhang ◽  
Renjie Jiang ◽  
Jinlin Zhang ◽  
Huaqing Wang ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Influenza A ◽  
Chinese Women ◽  
Seroconversion Rate ◽  
Exact Probability ◽  
H1n1 Vaccine ◽  
Influenza A H1n1 ◽  
Prolonged Pregnancy ◽  
A Prospective Study ◽  
Fetus And Neonate

ABSTRACTTo monitor and evaluate the safety of the influenza A(H1N1) vaccine in pregnant women and its influence on the fetus and neonate, we performed a prospective study in which 122 pregnant Chinese women who received the influenza A(H1N1) vaccine and 104 pregnant women who did not receive any vaccine (serving as controls) were observed. The results indicated that the seroconversion rate in the vaccinated group was 90.4% (95% confidence interval [CI], 82.6% to 95.5%). The rate of adverse events following immunization in the pregnant women who received the influenza A(H1N1) vaccine was 3.3%. The spontaneous abortion rates in the vaccinated group and the unvaccinated group were 0.8% and 1.9%, respectively (exact probability test,P= 0.470), the prolonged-pregnancy rates were 8.2% and 4.8%, respectively (χ2= 1.041,P= 0.308), the low-birth-weight rates were 1.6% and 0.95%, respectively (exact probability test,P= 1.000), and the spontaneous-labor rates were 70.5% and 75%, respectively (χ2= 0.573,P= 0.449). All newborns who have an Apgar score of ≥7 are considered healthy; Apgar scores of ≥9 were observed in 38.5% and 57.7% of newborns in the vaccinated group and the unvaccinated group, respectively (χ2= 8.274,P= 0.004). From these results, we conclude that the influenza A(H1N1) vaccine is safe for pregnant women and has no observed adverse effects on fetal growth. (This study has been registered at ClinicalTrials.gov under registration no. NCT01842997.)

scholarly journals Immunogenicity and Safety of the Influenza A/H1N1 2009 Inactivated Split-Virus Vaccine in Young and Older Adults: MF59-Adjuvanted Vaccine versus Nonadjuvanted Vaccine

2011 ◽  
Vol 18 (8) ◽  
pp. 1358-1364 ◽  
Author(s):  
Hee Jin Cheong ◽  
Joon Young Song ◽  
Jung Yeon Heo ◽  
Ji Yun Noh ◽  
Won Suk Choi ◽  
...  
Keyword(s):  
Young Adults ◽  
Influenza A ◽  
Geometric Mean ◽  
The Elderly ◽  
Medicinal Products ◽  
H1n1 Vaccine ◽  
Practical Advantage ◽  
Adjuvanted Vaccine ◽  
Influenza A H1n1 ◽  
Hemagglutinin Inhibition

ABSTRACTSince initial reports in April 2009, the pandemic influenza A (H1N1) virus has spread globally. Influenza vaccines are the primary method for the control of influenza and its complications. We conducted a multicenter clinical trial to evaluate the immunogenicity and safety of H1N1 vaccine (Green Cross Co.) in young adults (18 to 64 years) and the elderly (≥65 years) using a two-dose regimen, with the doses administered 21 days apart. Three different regimens of hemagglutinin antigen were comparatively analyzed: 3.75 μg (MF59 adjuvanted) versus 7.5 μg (MF59 adjuvanted) versus 15 μg (nonadjuvanted) in young adults and 3.75 μg (MF59 adjuvanted) versus 7.5 μg (MF59 adjuvanted) in the elderly. In young adults, all three vaccine regimens met the European Agency for the Evaluation of Medicinal Products (EMA) criteria after the first dose. In the elderly, on day 21 after the first dose, the rates of seroprotection and seroconversion were significantly higher for the 7.5-μg dose of MF59 adjuvanted vaccine than for the 3.75-μg dose (58.0% versus 44.3% [P= 0.03] and 53.7% versus 37.2% [P< 0.01], respectively). After the second dose, the geometric mean titer (GMT) increment was blunted with a 15-μg dose of nonadjuvanted vaccine, whereas the GMT increased about 2-fold with MF59 adjuvanted vaccines. In conclusion, a single 7.5-μg dose of MF59 adjuvanted vaccine would have a practical advantage over a two-dose, 3.75-μg, MF59 adjuvanted vaccine priming schedule. Following a two-dose priming schedule, the increase in hemagglutinin inhibition titers was higher with MF59 adjuvanted vaccine than with nonadjuvanted vaccine.

Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam

Vaccine ◽  
2018 ◽  
Vol 36 (46) ◽  
pp. 6918-6925
Author(s):  
Ho Vinh Thang ◽  
Vu Minh Huong ◽  
John C. Victor ◽  
Cao Bao Van ◽  
Nguyen Tuyet Nga ◽  
...  
Keyword(s):  
Influenza A ◽  
Vaccine Candidate ◽  
H1n1 Vaccine ◽  
Influenza A H1n1

SAT0146 BehÇEt´S Disease Activity: An Important Factor for Immunogenecity of Unadjuvanted Influenza A/H1N1 Vaccine

2013 ◽  
Vol 72 (Suppl 3) ◽  
pp. A631.2-A631
Author(s):  
L. L. Prado ◽  
C. G. S. Saad ◽  
J. C. B. Moraes ◽  
A. C. M. Ribeiro ◽  
N. E. Aikawa ◽  
...  
Keyword(s):  
Disease Activity ◽  
Influenza A ◽  
H1n1 Vaccine ◽  
Influenza A H1n1

scholarly journals The results of clinical trial on immunogenicity of adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old

2020 ◽  
Vol 22 ◽  
pp. 02001
Author(s):  
O.P. Kovtun ◽  
V.V. Romanenko ◽  
I.V. Feldblum ◽  
A.U. Sabitov ◽  
A.V. Ankudinova
Keyword(s):  
Influenza Vaccine ◽  
Pediatric Population ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Age Groups ◽  
Quadrivalent Vaccine ◽  
Seroprotection Rate ◽  
Double Blind ◽  
Care Workers ◽  
B Virus

Russian health care workers currently use trivalent influenza vaccines with a strain of a single lineage of type B virus. The purpose of our study was to evaluate the immunogenicity of an adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old. We compared this new vaccine to a trivalent Grippol Plus vaccine in terms of immunogenicity against certain strains of influenza virus. A multicenter double-blind randomized controlled clinical study was conducted in 440 pediatric subjects (age groups: 6 to 11; 12 to 17 y.o.); 221 subjects received Grippol Quadrivalent, 219 – Grippol Plus. Vaccine immunogenicity was evaluated by seroprotection rate (SPR), seroconversion rate (SCR), geometric mean titer (GMT) of antibodies, and an X-fold rise in antibodies level (↑GMT). Antibodies quantification was done using hemagglutination inhibition assay (HAI) in serial serum dilutions. No significant differences were found between the two vaccines’ performance against A(H1N1), A(H3N2) strains or Victoria B virus. With respect to type A virus, both vaccines satisfied three of CPMP criteria (SPR, SCR, ↑GMT). With respect to Victoria B virus, the two vaccines met but one CPMP criterion (↑GMT). The immunogenicity against Yamagata B virus was evaluated only for Grippol Quadrivalent vaccine which met two of CPMP requirements (SCR, ↑GMT). Our findings suggest that in terms of its prophylactic efficiency, Grippol Quadrivalent vaccine is no inferior to the Grippol Plus one.

scholarly journals Immunogenicity of a Monovalent Pandemic Influenza A H1N1 Virus Vaccine with or without Prior Seasonal Influenza Vaccine Administration

2012 ◽  
Vol 19 (10) ◽  
pp. 1690-1692 ◽  
Author(s):  
Hidetoshi Igari ◽  
Akira Watanabe ◽  
Shunsuke Segawa ◽  
Akiko Suzuki ◽  
Mariko Watanabe ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Pandemic Influenza ◽  
Influenza A ◽  
H1n1 Virus ◽  
Geometric Mean ◽  
Vaccine Administration ◽  
Trivalent Influenza Vaccine ◽  
Influenza A H1n1 ◽  
Significant Difference ◽  
Antibody Titers

ABSTRACTThe immunogenicity of pandemic influenza A H1N1 virus (A/H1pdm) vaccine might be modified by prior seasonal trivalent influenza vaccine (sTIV) administration. We conducted a retrospective analysis of immunogenicity of 243 health care workers (number of sTIV-positive [sTIV+] subjects, 216; number of sTIV−subjects, 27) by hemagglutination inhibition. There was no significant difference in the ratios of antibody titers of ≥40 (41.2% versus 48.1%;P= 0.49) and fold increases in geometric mean titer (3.8 versus 4.5;P= 0.37). sTIV injected 7 to 10 days prior to A/H1pdm vaccine administration did not interfere with the immunogenicity of the latter.

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