Immunogenicity and tolerability of an AS03A-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults

Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age

“…Similarly, the immunogenicity of both seasonal influenza vaccines 16 and other non-adjuvanted H1N1 vaccines 22 in young children is less than in older children and adults. New-generation adjuvants (such as MF59 and AS03 B ) have been used to improve immunogenicity 13,14,35 and in this study the split-virion adjuvanted vaccine was highly immunogenic, even in young children, but was slightly less immunogenic in older children than in infants (3% per year with age), a pattern not previously described for inactivated vaccines.…”

“…Increased reactogenicity was seen with an MF59-adjuvanted H1N1 vaccine in children, 37 as well as in adult trials of oil-in-water adjuvanted vaccines. [13][14][15]23,35 The AS03 B -adjuvanted vaccine in this trial was similarly associated with more local reactions, and some increase in systemic reactions, compared with the whole-virion vaccine. The higher reactogenicity observed with the split-virion adjuvanted vaccine may influence parental uptake of the vaccine.…”

“…[13][14][15] Although whole-virion influenza vaccines have previously been associated with unacceptable reactogenicity rates, 16 H5N1 'mock-up' whole-virion vaccines were well tolerated, 17 and these vaccines avoid problems with egg-allergic individuals. 18 Use of cell culture for manufacture was expected T he first illness caused by a new influenza A virus was confirmed in the UK on 27 April 2009.…”

Selection of Adjuvants for Enhanced Vaccine Potency

“…AS03 has been used in the product Prepandrix (H5N1 vaccine from GSK) in EU for a few years. This adjuvant has been shown to enhance the initial priming effect of pandemic influenza vaccination and promote a rapid humoral response to a single boosting dose with a heterologous strain, not only reducing the dose of the antigen (up to 24 times) but also offering a better cross-protection against drifted strains in young, elderly, or Asian subjects [149,150]. In different studies, administration of AS03-adjuvanted H1N1 pandemic vaccine generated same level of immunogenicity as unadjuvanted vaccine at a four-fold higher dose in adults [151], and long-term protection in health care workers [152].…”

“…CEL-1000 (18-mer) is an analogue of peptide G (a peptide from human MHCII beta chain, aa [135][136][137][138][139][140][141][142][143][144][145][146][147][148][149], which is known to enhance immune responses of other immunogenic peptides. They can be conjugated to HIV (HGP-30) and malaria peptides as potential vaccines.…”