Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial

MF59®‐adjuvanted vaccines for seasonal and pandemic influenza prophylaxis

“…As the amount of antigen tested in both these studies is substantially more than is needed for protection against seasonal influenza strains, and given current limits on worldwide vaccine production capacity, measures to increase the immune response and reduce the antigen content are essential. This is particularly important as clinical trials have shown that two doses of adjuvanted H5N1 vaccine are necessary to satisfy regulatory criteria for immunogenicity 24 , 25 , 26 . Use of improved adjuvants may provide the best approach for cross‐reactive immune responses for both seasonal and pre‐pandemic vaccination.…”

Safety and immunogenicity of Sinovac’s prototype pandemic influenza H5N1 vaccines: a review on clinical trials

“…Previous trials have reported the cross‐reactivity of pandemic candidate vaccines 13 , 16 , 17 . Our whole‐virion H5N1 vaccine has shown good cross‐reactivity against the heterologous Indonesia and Anhui recombinant strains.…”

“…Many promising H5N1 vaccines including whole‐virion, split‐virion, adjuvanted and non‐adjuvanted vaccines have been developed and clinically evaluated, 6 , 11 , 12 , 13 some of which have been granted production licensure in different regions. All these achievements arm us with a powerful, if not sufficient, defence against the next human influenza pandemic.…”

Comparison of adverse events following immunization with pandemic influenza A (H1N1)pdm09 vaccine with or without adjuvant among health professionals in Rio de Janeiro, Brazil

“…The other vaccine used in the campaign, a split-virus AS03-adjuvanted vaccine, was based on pre-pandemic vaccines against influenza A (H5N1), which had a more restricted clinical use (Baras et al 2008, Girard et al 2010. The studies evaluating the influenza H5N1 vaccine containing the adjuvant AS03 have associated its presence with an increase in vaccine reactogenicity (Leroux-Roels et al 2007, Baras et al 2008, Rümke et al 2008) and trials conducted with the AS03-adjuvanted H1N1 pandemic vaccine also found high rates of adverse events. Local mild to moderate reactions were more common and serious adverse events were rarely reported (Carmona et al 2010, Roman et al 2010a, b, Waddington et al 2010, Nicholson et al 2011.…”

“…The GSK vaccine was the only vaccine that also contained an adjuvant, AS03, which is composed of squalene, DL-α tocopherol and polysorbate 80. Although this adjuvant had been previously used in prepandemic vaccines (Leroux-Roels et al 2007, Baras et al 2008, Rümke et al 2008, it was not present in any of the seasonal influenza vaccines that were used in previous campaigns. As AS03 was a new adjuvant with sparse evidence available on its safety in pregnant women, the WHO initially recommended that the first choice (when available) for this patient group should be non-adjuvanted inactivated preparations (WHO 2009b).…”