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

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.

Authors+Show Affiliations

Department of Pediatrics, University of Milan, Luigi Sacco Hospital, 20157 Milan, Italy. gianvincenzo.zuccotti@unimi.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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., ... Radaelli, G. (2009). Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus. Vaccine, 27(39), pp. 5357-62. doi: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 -