Innate profiles were comparable between AS01 B, AS01 E, and AS03 groups, and between AS04 and Alum groups. No distinct marker or signature was specific to one particular AS. After the second but not the first injection, median interferon (IFN)-γ levels were increased in the AS01 B group, and IFN-γ-inducible protein-10 levels and IFN-inducible genes upregulated in the AS01 and AS03 groups. All AS induced transient innate responses, including interleukin (IL)-6 and C-reactive protein (CRP), mostly peaking at 24 h post-vaccination and subsiding to baseline within 1–3 days. Blood protein, cellular, and mRNA innate responses were assessed at early time-points and up to 7 days after vaccination, and used with reactogenicity symptoms in linear regression analyses evaluating their correlation with HBs-specific CD4 + T-cell and antibody responses at day 44. A total of 291 participants aged 18–45 years were randomized 1:1:1:1:1 to receive HBsAg with AS01 B, AS01 E, AS03, AS04, or Alum/Al(OH) 3 at days 0 and 30 ( : NCT00805389). To elucidate the role of innate responses in vaccine immunogenicity, we compared early responses to hepatitis B virus (HBV) surface antigen (HBsAg) combined with different Adjuvant Systems (AS) in healthy HBV-naïve adults, and included these parameters in multi-parametric models of adaptive responses. 4Institute for Medical Immunology, Université Libre de Bruxelles, Gosselies, Belgium.
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Didierlaurent 1‡ On Behalf of the ECR-002 Study Group