British Journal of Clinical Pharmacology
British Journal of Clinical Pharmacology
5 years ago

Dose sparing and the lack of a dose–response relationship with an influenza vaccine in adult and elderly patients – a randomized, double-blind clinical trial

Laszlo Kalabay, Gergely Balaton, Adam Erdman, Peter Torzsa, Zoltan Vajo, Peter Vajo
Aims The currently licensed seasonal trivalent influenza vaccines contain 15 μg haemagglutinin per strain for adult, and up to 60 μg for elderly patients. However, due to recent shortages, dose sparing to increase production capacity would be highly desirable. In the present study, we attempted to find a dose–response relationship for immunogenicity and, thus, the optimal dose for seasonal influenza vaccines in adult and elderly patients. Methods A total of 256 subjects, including adult (aged 18–60 years) and elderly (aged over 60 years) individuals, were enrolled. Subjects were randomly assigned in a 1:1:1:1 ratio to receive a whole-virion, aluminium-adjuvanted trivalent influenza vaccine containing 3.5, 6, 9 or 15 μg haemagglutinin of seasonal A/H1N1, A/H3N2 and B influenza antigens manufactured by Omninvest Ltd., Hungary. Serum antibody titres against the vaccine virus strains were measured by haemagglutination inhibition. Result All vaccines were well tolerated. All four vaccines fulfilled all three immunogenicity licensing criteria, as determined by the European Committee for Proprietary Medicinal Products (CPMP)/Biotechnology Working Party (BWP)/214/96 guideline for all three virus strains and both age groups. The 3.5 μg vaccine showed 28% less seroconversion compared to the 15 μg dose in terms of influenza AH3N2 in the adult group (95% confidence interval –51, −3; P < 0.05). All other doses showed no significant difference in immunogenicity compared with the licensed vaccine containing 15 μg haemagglutinin. Conclusions Our data suggested that significant dose sparing is possible with the use of whole-virion vaccines and aluminium adjuvants, without compromising safety. This could have significant economic and public health impacts.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/bcp.13289

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.