Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to &lt;18 years of age: A prospective, open-label, multi-center trial

Oh, Chi Eun; Lee, Jina; Kang, Jin Han; Hong, Young Jin; Kim, Yun Kyung; Cheong, Hee Jin; Ahn, Young Joo; Kim, Sang Hoon; Lee, Hoan Jong

doi:10.1016/j.vaccine.2010.06.060

Cited by 33 publications

(53 citation statements)

References 16 publications

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“…Also, all patients fulfilled the international criteria for juvenile ARD, and the study benefited from the inclusion of a large patient population, an essential requirement to accurately define vaccine immunoresponse and safety, which was not met by previous studies of seasonal influenza vaccine 6,8 . Moreover, age-matching of the control group is essential because effectiveness of vaccine has a distinct pattern in children and adolescents 19 . Our report included only patients over age 9 years, excluding younger children, who have a lesser humoral response to influenza A H1N1/2009 vaccine 19,20 .…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, age-matching of the control group is essential because effectiveness of vaccine has a distinct pattern in children and adolescents 19 . Our report included only patients over age 9 years, excluding younger children, who have a lesser humoral response to influenza A H1N1/2009 vaccine 19,20 .…”

Section: Discussionmentioning

confidence: 99%

“…Arthralgia was a more frequent complaint of patients with juvenile ARD compared to healthy controls. Studies on influenza A/H1N1 2009 vaccine in healthy children and adolescents have not reported musculoskeletal complaints 19,20 , suggesting that the occurrence of this manifestation could be related to the patient's genetic background for rheumatic disease 40 .…”

Section: Discussionmentioning

confidence: 99%

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

Aikawa

Campos²,

Silva³

et al. 2011

J Rheumatol

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

Aikawa

Campos²,

Silva³

et al. 2011

J Rheumatol

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“…Seroprotection rates after influenza vaccination in adult and healthy pediatric populations are well studied. 9,10 The efficacy of influenza vaccination has also been reported in adults with various chronic diseases including rheumatoid arthritis 11,12 and in children with chronic arthritis. 13 For pediatric inflammatory bowel disease, one study of Mamula et al described an increased risk for an insufficient humoral immune response, 14 whereas another found a high prevalence of seroprotection after influenza vaccination.…”

Section: Immune Response To Influenza Vaccination In Children Treatedmentioning

confidence: 99%

Immune response to influenza vaccination in children treated with methotrexate or/and tumor necrosis factor-α inhibitors

et al. 2011

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“…Booster vaccination Second seasonal vaccination (16) 15 (20) 10 (14) 13 (19) 5 (7) 10 (16) 3 (5) 5 (8) Diarrhea Present 20 (27) 22 (30) 13 (18) 20 (29) 8 (12) 6 (10) 7 (11) 7 (12) Vomiting Present 12 (16) 11 (15) 8 (11) 10 (14) 2 (3) 1 (2) 5 (8) 2 (3) Irritability Present 9 (12) 11 (15) 9 (13) 6 (9) 3 (4) 6 (10) 4 (6) 2 (3) Change in eating habits Present 13 (17) 21 (28) 10 (14) 12 (17) 2 (3) 7 (11) 6 (10) 5 (8) Shivering Present 3 (4) 2 (3) 2 (3) 4 (6) 3 (4) 2 (3) 2 …”

Section: Second Vaccinationmentioning

confidence: 99%

Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children

Knuf¹,

Leroux‐Roels

Rümke³

et al. 2015

Human Vaccines & Immunotherapeutics

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Mass immunization of children has the potential to decrease infection rates and prevent the transmission of influenza. We evaluated the immunogenicity, safety, and tolerability of different formulations of cell-derived MF59-adjuvanted and nonadjuvanted A/H1N1 influenza vaccine in children and adolescents. This was a randomized, singleblind, multicenter study with a total of 666 healthy subjects aged 6 months-17 y in one of 3 vaccination groups, each receiving formulations containing different amounts of influenza A/H1N1 antigen with or without MF59. A booster trivalent seasonal MF59 vaccine was administered one year after primary vaccinations. Antibody titers were assessed by hemagglutination inhibition (HI) and microneutralization assays obtained on days 1, 22, 43, 366, and 387 (3 weeks post booster). Safety was monitored throughout the study. One vaccination with 3.75 mg of A/H1N1 antigen formulated with 50% MF59 (3.75_halfMF59) or 7.5 mg of A/H1N1 antigen formulated with 100% MF59 (7.5_fullMF59) induced an HI titer 1:40 in >70% of children in the 1-<3, 3-8, and 9-17 y cohorts; however, 2 vaccinations with nonadjuvanted 15 mg A/H1N1 antigen were needed to achieve this response in the 1-<3 and 3-8 y cohorts. Among children aged 6-11 months, 1 dose of 7.5_fullMF59 resulted in an HI titer 1:40 in >70% while 2 doses of 3.75_halfMF59 were required to achieve this result. All vaccines were well tolerated. Our findings support the immunogenicity and safety of the 3.75_halfMF59 (2 doses for children <12 months) and 7.5_fullMF59 vaccine formulations for use in children and adolescents aged 6 months to 17 y The use of the 3.75_halfMF59 could have the benefit of antigen and adjuvant sparing, increasing the available vaccine doses allowing vaccination of more people.

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Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to <18 years of age: A prospective, open-label, multi-center trial

Cited by 33 publications

References 16 publications

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

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

Immune response to influenza vaccination in children treated with methotrexate or/and tumor necrosis factor-α inhibitors

Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children

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