IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDY
Background: Children with type 1 diabetes (T1D) are at high risk for severe influenza. Objective. Our aim was to assess immunogenicity and safety of a trivalent subunit immunoadjuvant influenza vaccine in children with T1D. Methods. The prospective study carried out from September to November 2014 i...
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"Paediatrician" Publishers LLC
2016-11-01
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| Series: | Вопросы современной педиатрии |
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| Online Access: | https://vsp.spr-journal.ru/jour/article/view/1673 |
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| author | Аlla A. Tarasova Еlena V. Кolbasina Еlena F. Lukushkina Yury G. Kuzmichev Mikhail P. Kostinov |
| author_facet | Аlla A. Tarasova Еlena V. Кolbasina Еlena F. Lukushkina Yury G. Kuzmichev Mikhail P. Kostinov |
| author_sort | Аlla A. Tarasova |
| collection | DOAJ |
| description | Background: Children with type 1 diabetes (T1D) are at high risk for severe influenza. Objective. Our aim was to assess immunogenicity and safety of a trivalent subunit immunoadjuvant influenza vaccine in children with T1D. Methods. The prospective study carried out from September to November 2014 included children with T1D at the age from 3 to 17 years vaccinated against influenza by a trivalent subunit immunoadjuvant influenza vaccine and unvaccinated due to parental refusal. Anti-influenza virus antibodies were determined by passive hemagglutination reaction. Vaccine safety was assessed by a number of adverse events occurred within 6 days after its administration. Observation was carried out during 1 year after vaccination (to October-November 2015 inclusive). Results. Of 780 children with T1D followed-up by endocrinologists in Nizhny Novgorod region, the study included 94 children — 44 vaccinated and 50 unvaccinated matched by sex and age. As for influenza A/H1N1/California/07/09 virus strain, the seroprotection rate (antibody titre > 1:40) was 84%, seroconversion rate (4-fold increase in antibody titre) was 66%, seroconversion factor (average increase of the antibody titre and 95% confidence interval) was 20.6 (10.4–30.9), as for influenza A/H3N2/Texas/50/12 virus, it was 98%, 41%, and 9.9 (3.2–16.6), as for influenza B/Massachusetts/2/12 virus, it was 77%, 49%, and 7.7 (4.0–11.4), respectively. After 1 year, the conditionally protective antibody titres (> 1:40) to influenza A/H1N1/California/07/09 virus were in 32/43 (74%), to influenza A/H3N2/Texas/50/12 virus — in 38/43 (88%), to influenza B/Massachusetts/2/12 virus — in 25/43 (58%) vaccinated children, in unvaccinated ones — 23/49 (47%) 37/49 (76%), and 6/49 (12%), respectively. Mild local adverse events were observed in 5/44 (11%), general — in 1/44 (2%), intercurrent diseases — in 8/44 (18%) vaccinated children. Conclusion. Immunogenicity and safety of a trivalent subunit immunoadjuvant influenza vaccine in children with T1D have been confirmed. |
| format | Article |
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| institution | Matheson Library |
| issn | 1682-5527 1682-5535 |
| language | English |
| publishDate | 2016-11-01 |
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| spelling | doaj-art-a6c46b7e6da148f6b6e80ef9f98ae8462025-08-04T13:09:38Zeng"Paediatrician" Publishers LLCВопросы современной педиатрии1682-55271682-55352016-11-0115548949610.15690/vsp.v15i5.16231630IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDYАlla A. Tarasova0Еlena V. Кolbasina1Еlena F. Lukushkina2Yury G. Kuzmichev3Mikhail P. Kostinov4Nizhny Novgorod State Medical AcademyNizhny Novgorod Regional Children's Clinical HospitalNizhny Novgorod State Medical AcademyNizhny Novgorod State Medical AcademyMechnikov Research Institute of Vaccine and SeraBackground: Children with type 1 diabetes (T1D) are at high risk for severe influenza. Objective. Our aim was to assess immunogenicity and safety of a trivalent subunit immunoadjuvant influenza vaccine in children with T1D. Methods. The prospective study carried out from September to November 2014 included children with T1D at the age from 3 to 17 years vaccinated against influenza by a trivalent subunit immunoadjuvant influenza vaccine and unvaccinated due to parental refusal. Anti-influenza virus antibodies were determined by passive hemagglutination reaction. Vaccine safety was assessed by a number of adverse events occurred within 6 days after its administration. Observation was carried out during 1 year after vaccination (to October-November 2015 inclusive). Results. Of 780 children with T1D followed-up by endocrinologists in Nizhny Novgorod region, the study included 94 children — 44 vaccinated and 50 unvaccinated matched by sex and age. As for influenza A/H1N1/California/07/09 virus strain, the seroprotection rate (antibody titre > 1:40) was 84%, seroconversion rate (4-fold increase in antibody titre) was 66%, seroconversion factor (average increase of the antibody titre and 95% confidence interval) was 20.6 (10.4–30.9), as for influenza A/H3N2/Texas/50/12 virus, it was 98%, 41%, and 9.9 (3.2–16.6), as for influenza B/Massachusetts/2/12 virus, it was 77%, 49%, and 7.7 (4.0–11.4), respectively. After 1 year, the conditionally protective antibody titres (> 1:40) to influenza A/H1N1/California/07/09 virus were in 32/43 (74%), to influenza A/H3N2/Texas/50/12 virus — in 38/43 (88%), to influenza B/Massachusetts/2/12 virus — in 25/43 (58%) vaccinated children, in unvaccinated ones — 23/49 (47%) 37/49 (76%), and 6/49 (12%), respectively. Mild local adverse events were observed in 5/44 (11%), general — in 1/44 (2%), intercurrent diseases — in 8/44 (18%) vaccinated children. Conclusion. Immunogenicity and safety of a trivalent subunit immunoadjuvant influenza vaccine in children with T1D have been confirmed.https://vsp.spr-journal.ru/jour/article/view/1673children immunoadjuvant trivalent influenza vaccinetype 1 diabetessafetyimmunogenicity |
| spellingShingle | Аlla A. Tarasova Еlena V. Кolbasina Еlena F. Lukushkina Yury G. Kuzmichev Mikhail P. Kostinov IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDY Вопросы современной педиатрии children immunoadjuvant trivalent influenza vaccine type 1 diabetes safety immunogenicity |
| title | IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDY |
| title_full | IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDY |
| title_fullStr | IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDY |
| title_full_unstemmed | IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDY |
| title_short | IMMUNOGENICITY AND SAFETY OF A TRIVALENT SUBUNIT IMMUNOADJUVANT INFLUENZA VACCINE IN CHILDREN WITH TYPE 1 DIABETES: RESULTS OF A PROSPECTIVE COMPARATIVE STUDY |
| title_sort | immunogenicity and safety of a trivalent subunit immunoadjuvant influenza vaccine in children with type 1 diabetes results of a prospective comparative study |
| topic | children immunoadjuvant trivalent influenza vaccine type 1 diabetes safety immunogenicity |
| url | https://vsp.spr-journal.ru/jour/article/view/1673 |
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