Safety and immunogenicity of a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125) in healthy young adults.

Background: The need for worldwide seasonal and pandemic vaccine production has increased interest in the development of innovative technologies for influenza vaccine production. We evaluated a novel influenza vaccine consisting of the globular head of the HA1 domain of the A/Solomon Islands/3/2006 (H1N1) influenza virus (VAX125) genetically fused to the TLR5 ligand, flagellin, and produced in E. coli.

Immune responses of healthy subjects to a single dose of intramuscular inactivated influenza A/Vietnam/1203/2004 (H5N1) vaccine after priming with an antigenic variant.

Background: We administered a single dose of influenza A/Vietnam/1203/2004 (H5N1, clade 1) vaccine to subjects who had received 2 doses of influenza A/Hong Kong/156/1997 (H5N1, clade 0) vaccine in 1998.

Methods: Thirty-seven subjects previously vaccinated with a baculovirus-expressed recombinant hemagglutinin A/Hong Kong/156/1997 vaccine in 1998 received a single intramuscular dose of 90 microg of inactivated subvirion A/Vietnam/1203/2004 vaccine in 2006. Serum antibody was measured before vaccination and 28 and 56 days after vaccination.

Intranasal administration of a proteosome-influenza vaccine is well-tolerated and induces serum and nasal secretion influenza antibodies in healthy human subjects.

Two randomized, blinded, active comparator-controlled trials of a prototype monovalent A/Beijing/262/95 (H1N1) - proteosome vaccine delivered by intranasal spray were performed in healthy adults. Overall, the intranasal proteosome-adjuvanted vaccine was well-tolerated with only mild stuffy nose and rhinorrhea seen more frequently in recipients of vaccine than in recipients of intranasal saline, and there were no serious adverse events. The intranasal proteosome-adjuvanted vaccine induced serum hemagglutination inhibiting (HAI) and nasal secretory IgA (sIgA) responses specific for the influenza antigen.

Clinical responses to undiluted and diluted smallpox vaccine.

Background: To evaluate the potential to increase the supply of smallpox vaccine (vaccinia virus), we compared the response to vaccination with 10(8.1), 10(7.2), and 10(7.