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Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects.

ABSTRACT: BACKGROUND:The safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine (Sub/MF59; FLUAD, Novartis Vaccines) was evaluated among elderly Chinese subjects (> or = 60 years of age). After a preliminary Phase I, open-label study (n = 25) to assess safety 1-14 days post-vaccination, a comparative observer-blind, randomised, controlled clinical trial (n = 600) was performed to assess safety and immunogenicity versus a non-adjuvanted subunit influenza vaccine (Subunit; Agrippal, Novartis Vaccines). Subjects were randomised (2:1) to receive Sub/MF59 or Subunit. RESULTS:Both vaccines were well tolerated, with no vaccine-related serious adverse events reported during the Phase I trial. During the observer-blind study, local and systemic reactions were generally similar for both vaccines 1-22 days post-vaccination; however, injection-site induration was more frequent among the Subunit group (P < 0.05), and mild pain at the injection site and fever were more frequent among Sub/MF59 recipients (P < or = 0.005). Both vaccines induced a significant (P < 0.001) increase in geometric mean titres (GMTs) for the three strains tested, versus baseline; GMTs against A/H1N1, A/H3N2 and B were significantly higher in the Sub/MF59 group (P = 0.034, P < 0.001 and P = 0.005, respectively). GMT ratios against A/H1N1, A/H3N2 and B were also significantly higher in the Sub/MF59 group (P = 0.038, P < 0.001 and P = 0.006, respectively). Similarly, the percentage of subjects achieving seroprotection or seroconversion on Day 22 was greater for Sub/MF59 recipients, reaching significance for A/H3N2 (P < 0.001). CONCLUSION:MF59-adjuvanted subunit influenza vaccine is well tolerated by elderly Chinese subjects and induces a higher level of immunogenicity than a non-adjuvanted subunit influenza vaccine in this population that is at high risk of influenza-related complications. CLINICAL TRIAL REGISTRY:http://www.clinicaltrials.gov, NCT00310648.

SUBMITTER: Li R

PROVIDER: S-EPMC2291031 | biostudies-literature | 2008 Feb

REPOSITORIES: biostudies-literature

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Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects.

Li Rongcheng R Fang Hanhua H Li Yanping Y Liu Youping Y Pellegrini Michele M Podda Audino A

Immunity & ageing : I & A 20080220

<h4>Background</h4>The safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine (Sub/MF59; FLUAD, Novartis Vaccines) was evaluated among elderly Chinese subjects (> or = 60 years of age). After a preliminary Phase I, open-label study (n = 25) to assess safety 1-14 days post-vaccination, a comparative observer-blind, randomised, controlled clinical trial (n = 600) was performed to assess safety and immunogenicity versus a non-adjuvanted subunit influenza vaccine (Subunit; Agrippa ...[more]

PMID: 18289372

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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.

Dataset Information

Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects.

Publications

Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects.

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