Vaccines were urgently needed in 2009 against A/H1N1 pandemic
influenza. Based on the H5N1 experience, it was originally thought that 2 doses of an adjuvanted
vaccine were needed for adequate immunogenicity. We tested H1N1
vaccines with or without AF03, a
squalene-based adjuvant, in children. Two randomized, open-label, trials were conducted. Participants 3-17 y received two
injections of 3.8 µg or 7.5 µg
hemagglutinin (HA) with adjuvant or 15 µg HA without adjuvant. Participants aged 6-35 mo received two
injections of 1.9 µg or 3.8 µg HA with full or half dose adjuvant or 7.5 µg HA without adjuvant. All subjects 3 to 17 y reached seroprotection (hemagglutination inhibition (HI) titer ≥ 40) after the first dose of the adjuvanted
vaccine, and 94% and 98% in the 3-8 and 9-17 y groups respectively with the non-adjuvanted
vaccine. In children aged 6-35 mo responses were modest after one dose, but after two doses virtually all children were seroprotected regardless of HA or adjuvant dose. In this age group, antibody titers were 5 to 7 times higher after adjuvanted than non-adjuvanted
vaccine. The higher responses with the adjuvanted
vaccine were also reflected as better antibody persistence. There was no clustering of adverse events that would be suggestive of a safety signal. While a single injection was sufficient in subjects from 3 y, in children aged 6-35 mo two
injections of this A/H1N1 pandemic
influenza vaccine were required. Formulation of this
vaccine with adjuvant provided a significant advantage for immunogenicity in the latter age group.