Abstract
BackgroundAlthough seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an intradermal vaccination route. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly.MethodsElderly volunteers (age ≥ 65 years) were randomised to receive a single dose of trivalent seasonal influenza vaccine: either a split-virion vaccine containing 15 μg haemagglutinin [HA]/strain/0.1-ml dose administered intradermally, or a subunit vaccine (15 μg HA/strain/0.5-ml dose) adjuvanted with MF59C.1 and administered intramuscularly. Blood samples were taken before and 21 ± 3 days post-vaccination. Anti-HA antibody titres were assessed using haemagglutination inhibition (HI) and single radial haemolysis (SRH) methods. We aimed to show that the intradermal vaccine was non-inferior to the adjuvanted vaccine.ResultsA total of 795 participants were enrolled (intradermal vaccine n = 398; adjuvanted vaccine n = 397). Non-inferiority of the intradermal vaccine was demonstrated for the A/H1N1 and B strains, but not for the A/H3N2 strain (upper bound of the 95% CI = 1.53) using the HI method, and for all three strains by the SRH method. A post-hoc analysis of covariance to adjust for baseline antibody titres demonstrated the non-inferiority of the intradermal vaccine by HI and SRH methods for all three strains. Both vaccines were, in general, well tolerated; the incidence of injection-site reactions was higher for the intradermal (70.1%) than the adjuvanted vaccine (33.8%) but these reactions were mild and of short duration.ConclusionsThe immunogenicity and safety of the intradermal seasonal influenza vaccine in the elderly was comparable with that of the adjuvanted vaccine. Intradermal vaccination to target the immune properties of the skin appears to be an appropriate strategy to address the challenge of declining immune responses in the elderly.Trial registrationClinicalTrials.gov: NCT00554333.
Highlights
Seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults
Noninferiority was tested with haemagglutination inhibition (HI) and single radial haemolysis (SRH) methods, and was defined as the upper bound of the 95% confidence intervals (CIs) around the post-vaccination ratios of geometric mean titres (GMT)
One participant in the intradermal vaccine group had a cardiac arrest that led to death on day 20
Summary
Seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly. The World Health Organization (WHO) recommends vaccination of people at high risk of severe influenza or associated complications, including elderly people [1]. The seasonal influenza vaccine has been shown to be effective in reducing influenza-like illness confirmed by laboratory tests and influenza-associated morbidity and mortality in high-risk groups [6,7,8]. The immune response to the vaccine is lower in the elderly than in younger healthy adults [9], due to a decline in immune function with age ('immunosenescence') [10]
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