From:  Flagellin fusion proteins as self-adjuvanting vaccines for viral infections and cancer

 Studies of flagellin fusion proteins for influenza vaccination.

RefAntigen/epitopeEpitope location and adjuvantSpecies/route of adminSummary of observed immune responses and results
[92]11–15 a.a. B-cell, Th, and CTL epitopes from HA or NPHV, noneMice, i.n.Flagellins containing viral T-cell epitopes induce T-cell proliferation ex vivo and confer 100% protection from a lethal dose of influenza in mice up to 7 months post vaccination
[93]11–15 a.a. B-cell, Th, and CTL epitopes from HA or NPHV, noneMice, i.n.Pre-immunisation with unmodified flagellin to induce immunity to the carrier protein had no effect on the efficacy of flagellin fusion vaccines given subsequently
[69]11–15 a.a. B-cell, Th, and CTL epitopes from HA or NPHV, noneMice, i.n.Induction of virus-specific IgG, splenocyte proliferation, and production of IL-2/IFN-γ, reduced viral titres in the lung, and protection from sub-lethal influenza challenge
[94]24 a.a. from matrix protein M2 ectodomainC-term, noneMice, s.c. or i.n.M2e-specific antibody responses lasting at least 10 months protected mice from a lethal challenge with influenza A virus, with efficacy comparable between s.c. or i.n. delivery
[14]175–271 a.a. from HA globular head domainsC-term, noneMice, s.c.Induction of HA-specific antibodies and protection from lethal challenge with mouse-adapted influenza PR8 virus
[78]222 a.a. from HA1 globular head domainC-term, noneHuman, i.m.A single dose up to 8 μg was well tolerated with no serious adverse events, increased titre of anti-HA1 antibodies lasting at least 6 months
[30]222 a.a. from HA1 globular head domainC-term, noneHuman, i.m.A single dose of 5 μg was well tolerated and induced a > 10-fold increase in HA1 antibody levels and seroprotection in elderly subjects
[89]222 a.a. from HA1 globular head domainC-term & HV, noneHuman, i.m.A single dose of 1.25 or 2.5 μg was well tolerated, inducing a 19-fold increase in anti-HA antibodies by day 21 in 97 subjects aged 18–64
[95]Various epitopes from HA1 globular head domainC-term & HV, noneHuman, i.m.A single dose of any of 4 flagellin fusions with HA1 attached at either the D3 domain or the C-terminus increased anti-HA1 titres by day 21 in adults aged 18–40
[5]222 a.a. from HA1-2 globular head domainN-term, noneMice, i.p.Boosts at 14 and 28 days elicited robust HA1-2-specific serum IgG1 and IgG2a titers lasting for at least 3 months post-immunisation
[47]Various epitopes from matrix protein 2 or HA2 domainHV, noneMice, i.n.Three different flagellin fusion proteins were cross-linked to form nanoparticles, immunized mice were fully protected against lethal doses of viral challenge
[48]22 a.a. from M2e and 33 a.a. from helix C of HA stalkN-term, noneMice, i.m.Flagellin was further modified with a coiled-coil domain to produce self-assembling nanoparticles, boosts at days 14 and 28, full protection from lethal viral challenge
[40]Various epitopes from M2e and HA2-2C-term & HV, noneMice, s.c.Flagellins containing both M2e and MA2-2 epitopes induced strong IgG, CD4+, and CD8+ T-cell responses to target antigens, and protection from lethal viral challenge

All antigens reported in Table 1 were expressed in E. coli, indicating that glycosylation of the antigen is not necessary to elicit immunoprotection. There was no use of additional adjuvant beyond flagellin itself in these studies. C-term: C-terminus; CTL: cytotoxic T-cell; HA: hemagglutinin; HV: hypervariable; IFN: interferon; i.m.: intramuscular; i.n.: intranasal; i.p.: intraperitoneal; M2e: matrix protein 2 extracellular domain; NP: nucleoprotein; N-term: N-terminus; s.c.: subcutaneous.