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Sökning: WFRF:(Plassmann Georg) > (2013) > Selection of an adj...

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FältnamnIndikatorerMetadata
00004501naa a2200469 4500
001oai:DiVA.org:uu-207034
003SwePub
008130909s2013 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-2070342 URI
0247 a https://doi.org/10.1186/1471-2334-13-3482 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Rumke, Hans C.4 aut
2451 0a Selection of an adjuvant for seasonal influenza vaccine in elderly people :b modelling immunogenicity from a randomized trial
264 c 2013-07-26
264 1b Springer Science and Business Media LLC,c 2013
338 a electronic2 rdacarrier
520 a Background: Improved influenza vaccines are needed to reduce influenza-associated complications in older adults. The aim of this study was to identify the optimal formulation of adjuvanted seasonal influenza vaccine for use in elderly people. Methods: This observer-blind, randomized study assessed the optimal formulation of adjuvanted seasonal influenza vaccine based on immunogenicity and safety in participants aged >= 65 years. Participants were randomized (similar to 200 per group) to receive one dose of non-adjuvanted vaccine or one of eight formulations of vaccine formulated with a squalene and tocopherol oil-in-water emulsion-based Adjuvant System (AS03(C), AS03(B) or AS03(A), with 2.97, 5.93 and 11.86 mg tocopherol, respectively) together with the immunostimulant monophosphoryl lipid A (MPL, doses of 0, 25 or 50 mg). Hemagglutination-inhibition (HI) antibody responses and T-cell responses were assessed on Day 0 and 21 days post-vaccination. The ratio of HI-based geometric mean titers in adjuvanted versus non-adjuvanted vaccine groups were calculated and the lower limit of the 90% confidence interval was transformed into a desirability index (a value between 0 and 1) in an experimental domain for each vaccine strain, and plotted in relation to the AS03 and MPL dose combination in the formulation. This model was used to assess the optimal formulation based on HI antibody titers. Reactogenicity and safety were also assessed. The immunogenicity and safety analyses were used to evaluate the optimal formulation of adjuvanted vaccine. Results: In the HI antibody-based model, an AS03 dose-response was evident; responses against the A/H1N1 and A/H3N2 strains were higher for all adjuvanted formulations versus non-adjuvanted vaccine, and for the AS03(A)-MPL25, AS03(B)-MPL25 and AS03(B)-MPL50 formulations against the B strain. Modelling using more stringent criteria (post hoc) showed a clear dose-range effect for the AS03 component against all strains, whereas MPL showed a limited effect. Higher T-cell responses for adjuvanted versus non-adjuvanted vaccine were observed for all except two formulations (AS03(C) and AS03(B)-MPL25). Reactogenicity increased with increasing AS03 dosage, and with MPL. No safety concerns were raised. Conclusions: Five formulations containing AS03(A) or AS03(B) were identified as potential candidates to improve immune responses to influenza vaccination; AS03(B) without MPL showed the best balance between improved immunogenicity and acceptable reactogenicity.
653 a Influenza vaccination
653 a Elderly
653 a Adjuvant system
653 a Dose comparison
653 a Immunogenicity
653 a Reactogenicity
653 a Safety
7001 a Richardus, Jan Hendrik4 aut
7001 a Rombo, Larsu Uppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD)4 aut0 (Swepub:uu)larra728
7001 a Pauksens, Karlisu Uppsala universitet,Infektionssjukdomar4 aut0 (Swepub:uu)karlpauk
7001 a Plassmann, Georg4 aut
7001 a Durand, Christelle4 aut
7001 a Devaster, Jeanne-Marie4 aut
7001 a Dewe, Walthere4 aut
7001 a Oostvogels, Lidia4 aut
7102 a Uppsala universitetb Centrum för klinisk forskning i Sörmland (CKFD)4 org
7730 t BMC Infectious Diseasesd : Springer Science and Business Media LLCg 13, s. 348-q 13<348-x 1471-2334
8564 u https://uu.diva-portal.org/smash/get/diva2:646647/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
8564 u https://bmcinfectdis.biomedcentral.com/track/pdf/10.1186/1471-2334-13-348
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-207034
8564 8u https://doi.org/10.1186/1471-2334-13-348

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