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A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59®-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration.
Hum Vaccin Immunother. 2014; 10(6):1701-10.HV

Abstract

Strategies to optimize responses to seasonal influenza vaccination in older adults include the use of adjuvants, higher antigen doses, and intradermal delivery. In this study adults aged ≥65 years (n = 450) received a single dose of 1 of 2 non-adjuvanted trivalent influenza vaccine (TIV) formulations administered intradermally (ID), both containing 6 µg of A/H1N1 and B, differing in A/H3N2 content (6 µg or 12 µg), or a single dose of 1 of 8 TIV formulations administered intramuscularly (IM) all containing 15 µg of A/H1N1 and B, differing in A/H3N2 hemagglutinin (HA) content (15 µg or 30 µg) and/or in MF59(®) adjuvant content (0%, 25%, 50%, or 100% of the standard dose). This paper focuses on the comparisons of low-dose non-adjuvanted ID, full-dose non-adjuvanted IM and full-dose MF59-adjuvanted IM formulations (n = 270). At day 22 post-vaccination, at least one European licensure immunogenicity criterion was met by all groups against all 3 strains; however, all three criteria were met against all 3 vaccine strains by the low-dose non-adjuvanted ID and the full-dose MF59-adjuvanted IM groups only. The full-dose MF59-adjuvanted IM group elicited significantly higher immune response vs. the low-dose non-adjuvanted ID formulations for most comparisons. The full-dose MF59 adjuvanted IM groups were associated with increased pain at the site of injection (P<0.01) compared to the ID groups, and the low-dose non-adjuvanted ID groups were associated with increased erythema, induration, and swelling at the injection site (P<0.0001) and unsolicited AEs compared with the IM groups. There were no differences between IM and ID groups in the frequencies of subjects experiencing solicited systemic reactions. Overall, while MF59 adjuvantation increased pain at the site of injection, and intradermal delivery increased unsolicited adverse events, erythema, induration, and swelling at the injection site, both strategies of vaccination strongly enhanced the immunogenicity of seasonal influenza vaccine in older adults compared with conventional non-adjuvanted intramuscular delivery.

TRIAL REGISTRATION

http://www.clinicaltrials.gov: NCT00848848.

Authors+Show Affiliations

Novartis Vaccines; Cambridge, MA USA.Novartis Vaccines; Cambridge, MA USA.Novartis Vaccines; Cambridge, MA USA.Centre for Vaccinology; CEVAC; Ghent University and University Hospital; Belgium.Centre for Vaccinology; CEVAC; Ghent University and University Hospital; Belgium.Novartis Vaccines; Cambridge, MA USA.Novartis Vaccines; Cambridge, MA USA.Novartis Vaccines; Cambridge, MA USA.NanoPass Technologies; Nes Ziona, Israel.Novartis Vaccines; Cambridge, MA USA.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24732325

Citation

Della Cioppa, Giovanni, et al. "A Dose-ranging Study in Older Adults to Compare the Safety and Immunogenicity Profiles of MF59®-adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines Following Intradermal and Intramuscular Administration." Human Vaccines & Immunotherapeutics, vol. 10, no. 6, 2014, pp. 1701-10.
Della Cioppa G, Nicolay U, Lindert K, et al. A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59®-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccin Immunother. 2014;10(6):1701-10.
Della Cioppa, G., Nicolay, U., Lindert, K., Leroux-Roels, G., Clement, F., Castellino, F., Galli, C., Groth, N., Levin, Y., & Del Giudice, G. (2014). A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59®-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Human Vaccines & Immunotherapeutics, 10(6), 1701-10. https://doi.org/10.4161/hv.28618
Della Cioppa G, et al. A Dose-ranging Study in Older Adults to Compare the Safety and Immunogenicity Profiles of MF59®-adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines Following Intradermal and Intramuscular Administration. Hum Vaccin Immunother. 2014;10(6):1701-10. PubMed PMID: 24732325.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59®-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. AU - Della Cioppa,Giovanni, AU - Nicolay,Uwe, AU - Lindert,Kelly, AU - Leroux-Roels,Geert, AU - Clement,Frédéric, AU - Castellino,Flora, AU - Galli,Cristina, AU - Groth,Nicola, AU - Levin,Yotam, AU - Del Giudice,Giuseppe, Y1 - 2014/04/14/ PY - 2014/4/16/entrez PY - 2014/4/16/pubmed PY - 2015/6/3/medline KW - MF59 KW - adjuvant KW - influenza KW - intradermal KW - seasonal KW - vaccine SP - 1701 EP - 10 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 10 IS - 6 N2 - UNLABELLED: Strategies to optimize responses to seasonal influenza vaccination in older adults include the use of adjuvants, higher antigen doses, and intradermal delivery. In this study adults aged ≥65 years (n = 450) received a single dose of 1 of 2 non-adjuvanted trivalent influenza vaccine (TIV) formulations administered intradermally (ID), both containing 6 µg of A/H1N1 and B, differing in A/H3N2 content (6 µg or 12 µg), or a single dose of 1 of 8 TIV formulations administered intramuscularly (IM) all containing 15 µg of A/H1N1 and B, differing in A/H3N2 hemagglutinin (HA) content (15 µg or 30 µg) and/or in MF59(®) adjuvant content (0%, 25%, 50%, or 100% of the standard dose). This paper focuses on the comparisons of low-dose non-adjuvanted ID, full-dose non-adjuvanted IM and full-dose MF59-adjuvanted IM formulations (n = 270). At day 22 post-vaccination, at least one European licensure immunogenicity criterion was met by all groups against all 3 strains; however, all three criteria were met against all 3 vaccine strains by the low-dose non-adjuvanted ID and the full-dose MF59-adjuvanted IM groups only. The full-dose MF59-adjuvanted IM group elicited significantly higher immune response vs. the low-dose non-adjuvanted ID formulations for most comparisons. The full-dose MF59 adjuvanted IM groups were associated with increased pain at the site of injection (P<0.01) compared to the ID groups, and the low-dose non-adjuvanted ID groups were associated with increased erythema, induration, and swelling at the injection site (P<0.0001) and unsolicited AEs compared with the IM groups. There were no differences between IM and ID groups in the frequencies of subjects experiencing solicited systemic reactions. Overall, while MF59 adjuvantation increased pain at the site of injection, and intradermal delivery increased unsolicited adverse events, erythema, induration, and swelling at the injection site, both strategies of vaccination strongly enhanced the immunogenicity of seasonal influenza vaccine in older adults compared with conventional non-adjuvanted intramuscular delivery. TRIAL REGISTRATION: http://www.clinicaltrials.gov: NCT00848848. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/24732325/A_dose_ranging_study_in_older_adults_to_compare_the_safety_and_immunogenicity_profiles_of_MF59®_adjuvanted_and_non_adjuvanted_seasonal_influenza_vaccines_following_intradermal_and_intramuscular_administration_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.28618 DB - PRIME DP - Unbound Medicine ER -