Safety and Immunogenicity of a Baculovirus-Expressed Hemagglutinin Influenza Vaccine

Abstract

clinicaltrials.gov Identifier: NCT00328107.

Insect Cell-Based Quadrivalent Seasonal Influenza Virus-like Particles Vaccine Elicits Potent Immune Responses in Mice

“…Among the type A VLPs, the HAI titer was higher against A/H3N2 compared to A/H1N1, while in type B, Yamagata-VLPs exhibited higher titers than the Victoria-VLPs. This trend mirrors findings in clinical trials involving elderly populations, where trivalent egg-based inactivated virus vaccines and recombinant HA protein-based vaccines consistently showed favorable antibody responses toward the A/H3N2 virus over the A/H1N1 and type B viruses [40][41][42][43][44].…”

FluBlok, a recombinant hemagglutinin influenza vaccine

“…The higher HA content offers the potential to provide cross protection for which preliminary evidence has been presented, but also the possibility for longer lasting and improved immunogenicity. 15,20 Data obtained with FluBlok are consistent with studies that demonstrated increased doses of purified HA and subvirion vaccines produce an enhanced antibody response in both the elderly and healthy adult populations. 1,2 Description of trivalent FluBlok vaccine clinical studies PSC01, PSC03, PSC04 and PSC06 PSC01 was a randomized, prospective, double-blind, placebo-controlled multicenter study in which healthy adults age 18-49 years of age were enrolled during the 2004-2005 influenza season.…”

Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults

“…The FDA initially licensed Flublok in 2013 for the prevention of influenza in adults 18–49 years of age on the basis of two placebo-controlled clinical studies, PSC01 and PSC04. The first study PSC01 demonstrated that including three times more HA antigen (45 versus 15 μg) resulted in improved antibody responses, confirming the results of an earlier clinical study [Treanor et al 2007]. In addition, studies PSC03 and PSC06 demonstrated improved immunogenicity of Flublok for the influenza A viruses [Keitel et al 2010; Baxter et al 2011] as reported for increased antigen concentration of other IIVs [Keitel et al 1994, 1996].…”