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Immunogenicity of trivalent influenza vaccines in patients with chronic kidney disease undergoing hemodialysis: MF59-adjuvanted versus non-adjuvanted vaccines.

ABSTRACT: Patients with chronic kidney disease (CKD) are at an increased risk of morbidity and mortality from influenza. However, the immunogenicity of influenza vaccine is known to be attenuated in these patients. In this study, the immunogenicity of MF59-adjuvanted and non-adjuvanted trivalent influenza vaccines was compared in CKD patients undergoing hemodialysis (HD).During 2013-2014, 179 CKD patients undergoing HD participated in the study. The patients were randomized into either MF59-adjuvanted vaccine group or non-adjuvanted vaccine group and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1 month (88 patients in MF59-adjuvanted vaccine group and 86 patients in non-adjuvanted vaccine group) and 6 months post vaccination. Levels of hemagglutination inhibition antibodies were measured.The seroconversion rate of all 3 vaccine strains at 1 month post-vaccination was significantly higher in the MF59-adjuvanted group than in the non-adjuvanted group (47.7% vs. 17.4%, A/H1N1; 42.0% vs. 16.3%, A/H3N2; 31.8% vs. 7.0%, B, P < 0.01). One month post-vaccination, the fold increase in geometric mean titer from pre-vaccination for A/H1N1, A/H3N2 and B viruses was significantly greater in the MF59-adjuvanted group than in the non-adjuvanted group. In elderly patients (?65 years), the seroconversion rate at 1 month post-vaccination against influenza B strain was higher in the MF59-adjuvanted group than in the non-adjuvanted group (33.3% vs. 7.1%, P = 0.03).The MF59-adjuvanted influenza vaccine showed better immunogenicity than the non-adjuvanted influenza vaccine in CKD patients undergoing HD.

SUBMITTER: Noh JY

PROVIDER: S-EPMC5137514 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Immunogenicity of trivalent influenza vaccines in patients with chronic kidney disease undergoing hemodialysis: MF59-adjuvanted versus non-adjuvanted vaccines.

Noh Ji Yun JY Song Joon Young JY Choi Won Suk WS Lee Jacob J Seo Yu Bin YB Kwon Young Joo YJ Ko Gang Jee GJ Cha Dae Ryong DR Kang Young Sun YS Lee Young-Ki YK Cheong Hee Jin HJ Kim Woo Joo WJ

Human vaccines & immunotherapeutics 20161101 11

<h4>Backgrounds</h4>Patients with chronic kidney disease (CKD) are at an increased risk of morbidity and mortality from influenza. However, the immunogenicity of influenza vaccine is known to be attenuated in these patients. In this study, the immunogenicity of MF59-adjuvanted and non-adjuvanted trivalent influenza vaccines was compared in CKD patients undergoing hemodialysis (HD).<h4>Methods</h4>During 2013-2014, 179 CKD patients undergoing HD participated in the study. The patients were random ...[more]

PMID: 27802078

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Project description:Influenza is a major cause of respiratory disease leading to hospitalization in young children. However, seasonal trivalent influenza vaccines (TIVs) have been shown to be ineffective and poorly immunogenic in this population. The development of live-attenuated influenza vaccines and adjuvanted vaccines are important advances in the prevention of influenza in young children. The oil-in-water emulsions MF59 and adjuvant systems 03 (AS03) have been used as adjuvants in both seasonal adjuvanted trivalent influenza vaccines (ATIVs) and pandemic monovalent influenza vaccines. Compared with non-adjuvanted vaccine responses, these vaccines induce a more robust and persistent antibody response for both homologous and heterologous influenza strains in infants and young children. Evidence of a significant improvement in vaccine efficacy with these adjuvanted vaccines resulted in the use of the monovalent (A/H1N1) AS03-adjuvanted vaccine in children in the 2009 influenza pandemic and the licensure of the seasonal MF59 ATIV for children aged 6?months to 2 years in Canada. The mechanism of action of MF59 and AS03 remains unclear. Adjuvants such as MF59 induce proinflammatory cytokines and chemokines, including CXCL10, but independently of type-1 interferon. This proinflammatory response is associated with improved recruitment, activation and maturation of antigen presenting cells at the injection site. In young children MF59 ATIV produced more homogenous and robust transcriptional responses, more similar to adult-like patterns, than did TIV. Early gene signatures characteristic of the innate immune response, which correlated with antibody titers were also identified. Differences were detected when comparing child and adult responses including opposite trends in gene set enrichment at day 3 postvaccination and, unlike adult data, a lack of correlation between magnitude of plasmablast response at day 7 and antibody titers at day 28 in children. These insights show the utility of novel approaches in understanding new adjuvants and their importance for developing improved influenza vaccines for children.

Project description:IntroductionEffective, programmatically suitable influenza vaccines are needed for low-resource countries.Materials and methodsThis phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012-2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6-11, 12-35, and 36-71 months. All participants were vaccine-naïve and received two doses of study vaccine 4 weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events.Results296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6-11, 12-35, and 36-71 months receiving TIV had HI titers ≥1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6-11, 12-35, and 36-71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5-38.4 °C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo.ConclusionsBoth aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.

Project description:UnlabelledStrategies 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 registrationhttp://www.clinicaltrials.gov: NCT00848848.

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Immunogenicity of trivalent influenza vaccines in patients with chronic kidney disease undergoing hemodialysis: MF59-adjuvanted versus non-adjuvanted vaccines.

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Immunogenicity of trivalent influenza vaccines in patients with chronic kidney disease undergoing hemodialysis: MF59-adjuvanted versus non-adjuvanted vaccines.

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