Immunogenicity and safety of Fluzone intradermal and high-dose influenza vaccines in older adults ≥65 years of age: A randomized,controlled, phase II trial |
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Authors: | Peter Tsang Geoffrey J. Gorse Cynthia B. Strout Malcolm Sperling David P. Greenberg Ayca Ozol-Godfrey Carlos DiazGranados Victoria Landolfi |
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Affiliation: | 1. Sanofi Pasteur, Discovery Drive, Swiftwater, PA 18372, USA;2. Division of Infectious Diseases, Allergy and Immunology, Saint Louis University, Edward A. Doisy Research Center, 8th Floor, 1100 S. Grand Blvd., St. Louis, MO 63104, USA;3. Coastal Carolina Research Center, 1156 Bowman Rd., Mount Pleasant, SC 29464, USA;4. Edinger Medical Group, 9900 Talbert Ave., Fountain Valley, CA 92708, USA |
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Abstract: | We conducted a randomized, controlled, multicenter, phase II study to evaluate the immunogenicity and safety of an investigational intradermal (ID) trivalent influenza vaccine (TIV) and a high-dose (HD) intramuscular (IM) TIV in older adults (≥65 years of age). Older adult subjects were immunized with ID vaccine containing either 15 μg hemagglutinin (HA)/strain (n = 636) or 21 μg HA/strain (n = 634), with HD IM vaccine containing 60 μg HA/strain (n = 320), or with standard-dose (SD) IM vaccine (Fluzone®; 15 μg HA/strain; n = 319). For comparison, younger adults (18–49 years of age) were immunized with SD IM vaccine. In older adults, post-vaccination geometric mean titers induced by the ID vaccines were superior to those induced by the SD IM vaccine for the A/H1N1 and A/H3N2 strains and non-inferior for the B strain. Seroconversion rates induced by the ID vaccines were superior to those induced by the SD IM vaccine in older adults for the A/H1N1 and B strains and non-inferior for the A/H3N2 strain. Results did not differ significantly for the two ID vaccine dosages. Post-vaccination geometric mean titers, seroconversion rates, and most seroprotection rates were significantly higher in HD vaccine recipients than in older adult recipients of the SD IM or ID vaccines and, for most measures, were comparable to those of younger adult SD IM vaccine recipients. Injection-site reactions, but not systemic reactions or unsolicited adverse events, were more common with the ID vaccines than with the IM vaccines. No treatment-related serious adverse events were reported. This study demonstrated that: (1) the ID and HD vaccines were well-tolerated and more immunogenic than the SD IM vaccine in older adults; (2) the HD vaccine was more immunogenic than the ID vaccines in older adults; and (3) the HD vaccine in older adults and the SD IM vaccine in younger adults elicited comparable antibody responses (ClinicalTrials.gov identifier no.: NCT00551031). |
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Keywords: | AE, adverse event CI, confidence interval GMT, geometric mean titer HA, hemagglutinin HI, hemagglutination inhibition HD, high-dose inactivated trivalent influenza vaccine (60 μg HA/strain) for the intramuscular route ID, intradermal IM, intramuscular SD, standard-dose inactivated trivalent influenza vaccine (15 μg HA/strain) for the intramuscular route |
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