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Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus.
Vaccine. 2009 Aug 27; 27(39):5357-62.V

Abstract

To evaluate the long-lasting immunogenicity and reactogenicity of a virosomal influenza vaccine in subjects with type I diabetes, a trial was conducted during the 2007-2008 influenza season in Milan, Northern Italy. One hundred five subjects aged 9-30 years were randomized to receive by intramuscular injection vaccination by a single dose (0.5 ml) of either a virosomal (Inflexal V) (n=52) or a standard subunit (Influvac) (n=53) vaccine. Serum hemagglutinin inhibition antibody titres were determined against the three recommended influenza-like strains, A/H1N1, A/H3N2 and B, at pre-vaccination, and 1 and 6 months post-vaccination. Geometric mean titres were increased in the two groups 1 and 6 months post-vaccination (P<0.001). One month post-vaccination both vaccines met the CPMP requirement for immunogenicity with high seroprotection rates (>95%) for strains A/H1N1 and A/H3N2, and a seroprotection of 73% and 70% in the virosomal and subunit vaccine for strain B. Mean fold increase ranged 2.8 (A/H3N2)-6.2 (A/H1N1) in the virosomal group and 2.3 (A/H3N2)-4.8 (A/H1N1) in the subunit group. Immunogenicity declined 6 months post-vaccination in both groups, and the CPMP requirement for immunogenicity was satisfied only in the virosomal group. In subjects without pre-existing antibodies to strain B (titre <10), the virosomal vaccine showed higher immune response than the subunit vaccine 6 months post-vaccination, with a geometric mean titre (95% CI) of 40.2 (30.7-54.6) vs. 21.2 (14.6-30.8). Reactogenicity was similar in the two vaccines. All reactions were transient and not severe. The results indicate that in older children and young adults with type I diabetes influenza vaccination with a virosomal or a standard subunit vaccine is safe and adequately immunogenic against the three influenza vaccine strains. In addition, the virosomal vaccine may show better long-lasting immune response than the standard subunit vaccine, especially in subjects without pre-existing antibodies to influenza strains.

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Authors+Show Affiliations

Zuccotti GV
Department of Pediatrics, University of Milan, Luigi Sacco Hospital, 20157 Milan, Italy. gianvincenzo.zuccotti@unimi.it
Scaramuzza A
No affiliation info available
Riboni S
No affiliation info available
Mameli C
No affiliation info available
Pariani E
No affiliation info available
Tanzi E
No affiliation info available
Zanetti A
No affiliation info available
Radaelli G
No affiliation info available

MeSH

AdolescentAdultAntibodies, ViralChildDiabetes Mellitus, Type 1Double-Blind MethodHumansInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza VaccinesInfluenza, HumanProspective StudiesVaccines, VirosomeYoung Adult

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19607951

Citation

Zuccotti, Gian Vincenzo, et al. "Long-lasting Immunogenicity of a Virosomal Vaccine in Older Children and Young Adults With Type I Diabetes Mellitus." Vaccine, vol. 27, no. 39, 2009, pp. 5357-62.
Zuccotti GV, Scaramuzza A, Riboni S, et al. Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus. Vaccine. 2009;27(39):5357-62.
Zuccotti, G. V., Scaramuzza, A., Riboni, S., Mameli, C., Pariani, E., Tanzi, E., Zanetti, A., & Radaelli, G. (2009). Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus. Vaccine, 27(39), 5357-62. https://doi.org/10.1016/j.vaccine.2009.06.082
Zuccotti GV, et al. Long-lasting Immunogenicity of a Virosomal Vaccine in Older Children and Young Adults With Type I Diabetes Mellitus. Vaccine. 2009 Aug 27;27(39):5357-62. PubMed PMID: 19607951.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus. AU - Zuccotti,Gian Vincenzo, AU - Scaramuzza,Andrea, AU - Riboni,Sara, AU - Mameli,Chiara, AU - Pariani,Elena, AU - Tanzi,Elisabetta, AU - Zanetti,Alessandro, AU - Radaelli,Giovanni, Y1 - 2009/07/14/ PY - 2009/02/26/received PY - 2009/06/16/revised PY - 2009/06/24/accepted PY - 2009/7/18/entrez PY - 2009/7/18/pubmed PY - 2009/9/24/medline SP - 5357 EP - 62 JF - Vaccine JO - Vaccine VL - 27 IS - 39 N2 - To evaluate the long-lasting immunogenicity and reactogenicity of a virosomal influenza vaccine in subjects with type I diabetes, a trial was conducted during the 2007-2008 influenza season in Milan, Northern Italy. One hundred five subjects aged 9-30 years were randomized to receive by intramuscular injection vaccination by a single dose (0.5 ml) of either a virosomal (Inflexal V) (n=52) or a standard subunit (Influvac) (n=53) vaccine. Serum hemagglutinin inhibition antibody titres were determined against the three recommended influenza-like strains, A/H1N1, A/H3N2 and B, at pre-vaccination, and 1 and 6 months post-vaccination. Geometric mean titres were increased in the two groups 1 and 6 months post-vaccination (P<0.001). One month post-vaccination both vaccines met the CPMP requirement for immunogenicity with high seroprotection rates (>95%) for strains A/H1N1 and A/H3N2, and a seroprotection of 73% and 70% in the virosomal and subunit vaccine for strain B. Mean fold increase ranged 2.8 (A/H3N2)-6.2 (A/H1N1) in the virosomal group and 2.3 (A/H3N2)-4.8 (A/H1N1) in the subunit group. Immunogenicity declined 6 months post-vaccination in both groups, and the CPMP requirement for immunogenicity was satisfied only in the virosomal group. In subjects without pre-existing antibodies to strain B (titre <10), the virosomal vaccine showed higher immune response than the subunit vaccine 6 months post-vaccination, with a geometric mean titre (95% CI) of 40.2 (30.7-54.6) vs. 21.2 (14.6-30.8). Reactogenicity was similar in the two vaccines. All reactions were transient and not severe. The results indicate that in older children and young adults with type I diabetes influenza vaccination with a virosomal or a standard subunit vaccine is safe and adequately immunogenic against the three influenza vaccine strains. In addition, the virosomal vaccine may show better long-lasting immune response than the standard subunit vaccine, especially in subjects without pre-existing antibodies to influenza strains. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/19607951/Long_lasting_immunogenicity_of_a_virosomal_vaccine_in_older_children_and_young_adults_with_type_I_diabetes_mellitus_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(09)00960-8 DB - PRIME DP - Unbound Medicine ER -