A phase III, randomized, open-label study to assess the tolerability and immunogenicity of an H5N1 influenza vaccine administered to healthy adults with a 1-, 2-, 3-, or 6-week interval between first and second doses

Assessment of Antigen-Specific and Cross-Reactive Antibody Responses to an MF59-Adjuvanted A/H5N1 Prepandemic Influenza Vaccine in Adult and Elderly Subjects

“…This clinical trial evaluated the immunogenicity and safety profiles of Antibody responses against the vaccine antigen strain were sufficient to meet the European licensure criteria after two doses in both adult and elderly subjects. The results of this study are consistent with similar trials of MF59-adjuvanted A/H5N1 vaccine containing A/Vietnam/1194/2004 strain antigen, which also found that adult and elderly subjects require two vaccine doses (2,4). Modeling studies suggest that A/H5N1 vaccines conferring even moderate heterologous protection can substantially mitigate the impact of a pandemic (11).…”

“…The investigational vaccine was generally well tolerated by adult and elderly subjects, with the majority of reactions being of mild to moderate severity and rapidly resolved. The tolerability profiles generated during this study were similar to those observed in other trials of MF59-adjuvanted A/H5N1 vaccines in adults and the elderly (2,4,21). MF59 has been shown to promote long-term antibody persistence (14,32), an element essential to successful pandemic vaccination strategy.…”

Safety and immunogenicity of influenza whole inactivated virus vaccines: A phase I randomized clinical trial

“…All the same, after one dose of the non-adjuvanted BPL-inactivated pWIV vaccine already 50% of the subjects were seroprotected, which was comparable 29 or better [30][31][32] than in studies with formalin-inactivated H5N1 WIV vaccine adjuvanted with aluminum hydroxide. The immunogenicity after one and 2 doses of pWIV was also comparable 33 or better 34 than is published for H5N1 subunit vaccines with low HA dose but adjuvanted with MF59.…”

Immunogenicity of heterologous H5N1 influenza booster vaccination 6 or 18 months after primary vaccination in adults: A randomized controlled clinical trial

“…An oilin-water adjuvanted H5N1 vaccine candidate based on influenza A/Duck/Singapore/97 (H5N3) showed robust cross-immunity to A/Hong Kong/489/97 (H5N1), suggesting drift-variant immunity [21]. Subsequent studies of various vaccines based on the clade 1 A/Vietnam virus [11,[22][23][24][25][26][27][28], and the clade 2.1 A/Indonesia strain [24,29], have shown significant titers of cross-protective antibodies against these clades, as well as subclades 2.2 (Turkey), 2.3 (Anhui), and against the original clade 3 virus (Hong Kong/156/1997) [23].…”