Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Safety and Low Seroprotection/Seroconversion Rates of Pandemic Influenza A Vaccine (Anti-H1N1/2009) in Juvenile Systemic Lupus Erythematosus.
Campos3, Lucia M., Silva3, Clovis A. A., Aikawa3, Nadia, Bonfa5, Eloisa, Trudes3, Guilherme, Ribeiro5, Ana Cristina M., Saad5, Carla Gonçalves
Instituto Adolpho Lutz
Paediatric Rheumatology Unit, Faculdade de Medicina da Universidade de São Paulo
Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo
To assess immunogenicity and safety of pandemic influenza A (H1N1) 2009 virus vaccine in juvenile systemic lupus erythematosus (JSLE) patients.
75 JSLE patients and 64 age-matched healthy controls were vaccinated with the strain influenza A/California/7/2009 (H1N1) vaccine. All participants were older than 9 years and were evaluated pre and 21 days post-vaccination. Anti-H1N1 antibody titer in serum samples was determined by influenza hemagglutination-inhibition (HI) assay. Appropriate endpoints included the percentage of subjects achieving an HI antibody titer >=1:40 (seroprotection) and rates of seroconversion, defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post vaccination HI titer >=1:40 or a pre-vaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The mean age was similar in JSLE and controls (16.52±3.34 vs. 15.92±4.81 years, p=0.39). Among JSLE patients 74.6% were female, the mean follow up was 5.4 ± 3.6 years and treatments included: antimalarial in 74.7%, glucocorticoids in 68% and immunosuppressors in 60% of patients. Before immunization seroprotection was comparable in JSLE and controls (21.3 vs. 21.9%, p=1.00). After vaccination these percentages increased significantly to 74.6% (p<0.0001) in JSLE and to 95.3% (p<0.0001) in the control group. The percentage of seroprotection was, however, significantly lower in JSLE after immunization (74.6% vs. 95.3%, p=0.0009). Seroconversion rates were also inferior in JSLE compared to controls (62.7% vs. 89.1%, p<0.001) with a lower median titers in JSLE (160 vs. 320, p=0.008). The comparison of 47 seroconverters patients with the remaining 28 nonresponders revealed a similar mean age and disease duration, female predominance, frequency of immunomodulators and prednisone use. Nevertheless, the prednisone dose was lower in seroconverters vs. nonresponders (8.66±10.81 vs. 16.84± 18.51 mg/day, p=0.018). Concerning vaccine safety in JSLE patients, no difference in SLEDAI scores was observed before and after immunization (6.03±6.10 vs. 5.23±5.45, p=0.12). Nonresponders group had a higher SLEDAI before the vaccination compared to seroconverters (8±6.13 vs. 4.98±5.86, p=0.037) whereas the post-vaccine SLEDAI was alike in both group (5.36±4.03 vs. 5.21±6.15, p=0.91). No serious vaccine adverse events were observed during 2 months follow-up.
The pandemic influenza A (H1N1) 2009 virus vaccine is safe in JSLE patients; however the seroprotection/seroconversion rates were lower than healthy controls. This finding suggests the need of a boost, particularly in active lupus patients and those under high dose of glucocorticoid therapy. ClinicalTrials.gov Identifier: NCT01151644
To cite this abstract, please use the following information:
Campos, Lucia M., Silva, Clovis A. A., Aikawa, Nadia, Bonfa, Eloisa, Trudes, Guilherme, Ribeiro, Ana Cristina M., et al; Safety and Low Seroprotection/Seroconversion Rates of Pandemic Influenza A Vaccine (Anti-H1N1/2009) in Juvenile Systemic Lupus Erythematosus. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1437