Article: Cross-protection against drifted influenza viruses: Options offered by adjuvanted and intradermal vaccines.Andrea Orsi, Filippo Ansaldi, Daniela de Florentiis, Antonella Ceravolo, Valentina Parodi, Paola Canepa, Martina Coppelli, Giancarlo Icardi, Paolo Durando[show abstract] [hide abstract]
ABSTRACT: Antigenic drift, the evolutionary mechanism of influenza viruses, results in an increased susceptibility of vaccinated subjects against circulating viruses. New vaccines able to grant a broader and cross-reactive immune response against drifted influenza variants are needed. Several strategies were explored to enhance the immunogenicity of plain vaccines: adjuvants, carriers and intradermal administration of influenza vaccine emerge as a promising options. To evaluate the ability of a MF59™-adjuvanted and intradermal influenza vaccine to elicit an effective antibody response against circulating viruses presenting antigenic patterns different from those of the vaccine strains, we compared antibody responses elicited by "implemented" vaccines and conventional intramuscular trivalent inactivated vaccine against heterologous circulating influenza A viruses. Different studies, simulating different epidemiological pictures produced by the natural antigenic drift of seasonal influenza viruses, highlighted the superior cross-reactivity of the antibodies elicited by MF59™ and intradermal vaccines, compared with subunit or split vaccine against heterologous viruses.Human vaccines & immunotherapeutics. 01/2013; 9(3).
Article: 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.Filippo Ansaldi, Andrea Orsi, Daniela de Florentiis, Valentina Parodi, Emanuela Rappazzo, Martina Coppelli, Paolo Durando, Giancarlo Icardi[show abstract] [hide abstract]
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.Human vaccines & immunotherapeutics. 01/2013; 9(3).
Article: Carriage of Streptoccoccus pneumoniae in healthy adults aged 60 years or over in a population with very high and long-lasting pneumococcal conjugate vaccine coverage in children: Rationale and perspectives for PCV13 implementation.Filippo Ansaldi, Daniela de Florentiis, Paola Canepa, Antonella Ceravolo, Emanuela Rappazzo, Rocco Iudici, Mariano Martini, Gerardo Botti, Andrea Orsi, Giancarlo Icardi, Paolo Durando[show abstract] [hide abstract]
ABSTRACT: A serial cross-sectional study of nasopharyngeal carriage among adults aged 60 y or over was conducted in winter-spring 2012 with the aim to describe circulating Streptococcus pneumoniae in an area, Liguria Administrative Region, where the vaccine was implemented for a decade and coverage in pediatric age group reached a value close to 100% for more than 5 y, determining a picture of very high vaccine immunological pressure. The serotype-specific carriage picture in adults was compared with that observed in children by means of a cross-sectional study performed one year before using the same sampling and laboratory methods. Cluster sampling enrolled 283 adults, representative of the open population. Detection of multi-serotype carriage was performed using, real-time PCR and primer specific PCRs. Carriage prevalence of participants with at least one positive sample adjusted for age, i.e., period prevalence, was 18.7%, considering the Ligurian population as standard population, showing that the pneumococcal carriage in the elderly is not a rare event as emerged in other surveys. The long-term use of PCV7 has resulted in strong decrease of vaccine types carriage among adults and children. A multivariate analysis showed that age class and contact with children attending day care covariates were strongly associated with Streptococcus pneumoniae carriage. A strong link between the picture observed in < 5-y-old children and ≥ 60-y-old adults emerged: a strong correlation of specific-serotype prevalence between adults and children and risk factor analysis supported the role played by inter-age-group transmission.Human vaccines & immunotherapeutics. 01/2013; 9(3).
Article: Seasonal and pandemic (A/H1N1 2009) MF-59-adjuvanted influenza vaccines in complete remission non-Hodgkin lymphoma patients previously treated with rituximab containing regimens.Davide Bedognetti, Filippo Ansaldi, Elisa Zanardi, Paolo Durando, Mario Roberto Sertoli, Carlotta Massucco, Enrico Balleari, Omar Racchi, Gabriele Zoppoli, Andrea Orsi, Cristiano Alicino, Giancarlo Icardi, Francesco M Marincola, Simonetta Zupo, Manlio Ferrarini, Andrea De MariaBlood 08/2012; 120(9):1954-7. · 9.90 Impact Factor
Article: Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults.Filippo Ansaldi, Laura Valle, Daniela de Florentiis, Valentina Parodi, Giuseppe Murdaca, Bianca Bruzzone, Paolo Durando, Maurizio Setti, Giancarlo Icardi[show abstract] [hide abstract]
ABSTRACT: This study evaluated safety, tolerability and immunogenicity of intradermal (ID) trivalent inactivated split influenza vaccine, with a lower antigen content (9 mcg HA per strain) than the conventional intramuscular one (15 mcg), in HIV-1-infected adults younger than 60 years. A total of 54 HIV-1-positive participants were enrolled and randomly assigned to receive a single dose of either ID-administered low-antigen-content split inactivated vaccine or intramuscularly-administered (IM) standard-dose inactivated split vaccine. Subjects were provided with a diary to monitor any local and/or systemic reactions to the vaccine for 7 days following vaccination. Serum samples were collected before, 28 days and 90 days after immunization. The plasma HIV-RNA and CD4+ T-lymphocyte count were checked at day 0 and day 90. Serum hemagglutination-inhibition (HI) activity for the three influenza strains included in the vaccine composition was measured to assess the antibody response at one month and 3 months after vaccination. Both vaccines showed optimal safety and tolerability profiles. All the three Committee for Medicinal Products for Human Use immunogenicity criteria for vaccine approval in adults younger than 60 were met by both vaccines against A(H1N1) and A(H3N2) viruses. Both vaccines met mean-fold-increase and seroprotection criteria but failed seroconversion criteria against B virus. No difference in terms of post-vaccination geometric mean titers, mean fold increase, seroprotection and seroconversion rates were found comparing ID and IM vaccines. In conclusion, the recently available low-antigen-content ID vaccine is safe, well-tolerated and as immunogenic as IM standard-dose influenza vaccine.Human vaccines & immunotherapeutics. 08/2012; 8(8).