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Head-to-head comparison of an intradermal and a virosome influenza vaccine in patients over the age of 60: evaluation of immunogenicity, cross-protection, safety and tolerability
Head-to-head comparison of an intradermal and a virosome influenza vaccine in patients over the age of 60: evaluation of immunogenicity, cross-protection, safety and tolerability
- Publication Year :
- 2013
-
Abstract
- In the present study we first compare immunogenicity against vaccine and heterologous circulating A(H1N1)pdm09 strains, tolerability and safety of intradermal Intanza 15 μg and of virosomal adjuvanted, intramuscularly delivered influenza vaccine, Inflexal V, in healthy elderly volunteers. Five-hundred participants were enrolled in the study and randomly assigned to the two vaccine groups to receive either one dose of Intanza 15 μg or Inflexal V vaccine. All subjects reported solicited local and systemic reactions occurred within 7 d after vaccination and unsolicited adverse events up to 21 d post-immunization and any serious adverse event appeared during the study. A subset of 55 participants was randomly selected for immunogenicity and cross-protection evaluations. Serum samples were collected before and 1 and 3 mo after immunization. Antibody responses were measured using hemagglutination inhibition (HI) against all viruses used in the study and neutralization (NT) assays against A(H1N1)pdm09 strains. At least one of the CHMP criteria for influenza vaccine approval in the elderly was met by virosomal vaccine against all the tested viruses; intradermal vaccine met all criteria against all strains. Several parameters of immune response against strains with a different antigenic pattern from that of vaccine A/California/04/09(H1N1)pdm09 were significantly higher in the intradermal vaccine group compared with the virosomal group. Safety and systemic tolerability of both vaccines were excellent, but injection site reactions occurred significantly more frequently in the intradermal vaccination group. Immunogenicity of Intanza 15 μg intradermal vaccine tended to be higher than that of Inflexal V against heterologous strains in healthy elderly.
- Subjects :
- Male
Hemagglutination Inhibition Tests
Cross Protection
Antibodies, Viral
immunology/prevention /&/ control
Virosome
80 and over
Immunology and Allergy
Medicine
Viral
administration /&/ dosage/adverse effects/immunology
Aged, 80 and over
Intramuscular
Vaccines
biology
Immunogenicity
Middle Aged
Tolerability
epidemiology/pathology
Influenza Vaccines
Female
Antibody
Research Paper
Human
Injections, Intradermal
Drug-Related Side Effects and Adverse Reactions
Head to head
Influenza vaccine
Immunology
Heterologous
Injections, Intramuscular
Antibodies
Injections
blood
Neutralization Tests
Intradermal
Influenza, Human
Humans
Aged, Aged
80 and over, Antibodies
blood, Cross Protection, Drug-Related Side Effects and Adverse Reactions
epidemiology/pathology, Female, Hemagglutination Inhibition Tests, Humans, Influenza Vaccines
administration /&/ dosage/adverse effects/immunology, Influenza
immunology/prevention /&/ control, Injections
Intradermal, Injections
Intramuscular, Male, Middle Aged, Neutralization Tests, Vaccines
Aged
Pharmacology
business.industry
Virology
Influenza
Vaccines, Virosome
biology.protein
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....7682d140fe7f0b535b5c59e001e52a4d