tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2015 Jul 15:0. [Epub ahead of print]
[h=1]Safety and persistence of the humoral and cellular immune responses induced by two doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: two open, uncontrolled studies.[/h] Garcia-Sicilia J[SUP]1[/SUP], Ar?stegui J, Ome?aca F, Carmona A, Tejedor JC, Merino JM, Garc?a-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I.
[h=3]Author information[/h]
[h=3]Abstract[/h] In children, two AS03-adjuvanted A(H1N1)pdm09 vaccine doses given 21 days apart were previously shown to induce a high humoral immune response and to have an acceptable safety profile up to 42 days following the first vaccination. Here, we analysed the persistence data from two open-label studies, which assessed the safety, and humoral and cell-mediated immune responses induced by two doses of this vaccine. The first study was a phase II, randomised trial conducted in 104 children aged 6-35 months vaccinated with the A(H1N1)pdm09 vaccine containing 1.9 μg haemagglutinin antigen (HA) and AS03[SUB]B[/SUB] (5.93 mg tocopherol) and the second study, a phase III, non-randomised trial conducted in 210 children and adolescents aged 3-17 years vaccinated with the A(H1N1)pdm09 vaccine containing 3.75 μg HA and AS03[SUB]A[/SUB] (11.86 mg tocopherol). Approximately one year after the first dose, all children with available data were seropositive for haemagglutinin inhibition and neutralising antibody titres, but a decline in geometric mean antibody titres was noted. The vaccine induced a cell-mediated immune response in terms of antigen-specific CD4[SUP]+[/SUP] T-cells, which persisted up to one year post-vaccination. The vaccine did not raise any safety concern, though these trials were not designed to detect rare events. In conclusion, two doses of the AS03-adjuvanted A(H1N1)pdm09 vaccine at two different dosages had a clinically acceptable safety profile, and induced high and persistent humoral and cell-mediated immune responses in children aged 6-35 months and 3-17 years.
[h=4]KEYWORDS:[/h] AESI= adverse event of specific interest; AS03 adjuvant; AS03= tocopherol oil-in-water emulsion based adjuvant system; ATP= according to protocol; CHMP= Committee for Medicinal Products for Human Use; CI= confidence interval; CMI= cell-mediated immunity; GMFR= geometric mean fold rise; GMT= geometric mean titre; H1N1 pandemic vaccine; HA= haemagglutinin antigen; HI= haemagglutinin inhibition; IFN-γ= gamma interferon; IL-13= interleukin-13; IL-2= interleukin-2; MAE= medically attended event; PCR= polymerase chain reaction; SAE= serious adverse event; SCR= seroconversion rate; SPR= seroprotection rate; TH1= T helper 1; TH2= T helper 2; TNF-α= tumor necrosis factor alpha; VRR= vaccine response rate; WHO= World Health Organization; cell-mediated immunity; children; haemagglutinin inhibition; microneutralisation; pIMD= potential immune-mediated disease; persistence; safety
PMID: 26176592 [PubMed - as supplied by publisher]
[h=1]Safety and persistence of the humoral and cellular immune responses induced by two doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: two open, uncontrolled studies.[/h] Garcia-Sicilia J[SUP]1[/SUP], Ar?stegui J, Ome?aca F, Carmona A, Tejedor JC, Merino JM, Garc?a-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I.
[h=3]Author information[/h]
[h=3]Abstract[/h] In children, two AS03-adjuvanted A(H1N1)pdm09 vaccine doses given 21 days apart were previously shown to induce a high humoral immune response and to have an acceptable safety profile up to 42 days following the first vaccination. Here, we analysed the persistence data from two open-label studies, which assessed the safety, and humoral and cell-mediated immune responses induced by two doses of this vaccine. The first study was a phase II, randomised trial conducted in 104 children aged 6-35 months vaccinated with the A(H1N1)pdm09 vaccine containing 1.9 μg haemagglutinin antigen (HA) and AS03[SUB]B[/SUB] (5.93 mg tocopherol) and the second study, a phase III, non-randomised trial conducted in 210 children and adolescents aged 3-17 years vaccinated with the A(H1N1)pdm09 vaccine containing 3.75 μg HA and AS03[SUB]A[/SUB] (11.86 mg tocopherol). Approximately one year after the first dose, all children with available data were seropositive for haemagglutinin inhibition and neutralising antibody titres, but a decline in geometric mean antibody titres was noted. The vaccine induced a cell-mediated immune response in terms of antigen-specific CD4[SUP]+[/SUP] T-cells, which persisted up to one year post-vaccination. The vaccine did not raise any safety concern, though these trials were not designed to detect rare events. In conclusion, two doses of the AS03-adjuvanted A(H1N1)pdm09 vaccine at two different dosages had a clinically acceptable safety profile, and induced high and persistent humoral and cell-mediated immune responses in children aged 6-35 months and 3-17 years.
[h=4]KEYWORDS:[/h] AESI= adverse event of specific interest; AS03 adjuvant; AS03= tocopherol oil-in-water emulsion based adjuvant system; ATP= according to protocol; CHMP= Committee for Medicinal Products for Human Use; CI= confidence interval; CMI= cell-mediated immunity; GMFR= geometric mean fold rise; GMT= geometric mean titre; H1N1 pandemic vaccine; HA= haemagglutinin antigen; HI= haemagglutinin inhibition; IFN-γ= gamma interferon; IL-13= interleukin-13; IL-2= interleukin-2; MAE= medically attended event; PCR= polymerase chain reaction; SAE= serious adverse event; SCR= seroconversion rate; SPR= seroprotection rate; TH1= T helper 1; TH2= T helper 2; TNF-α= tumor necrosis factor alpha; VRR= vaccine response rate; WHO= World Health Organization; cell-mediated immunity; children; haemagglutinin inhibition; microneutralisation; pIMD= potential immune-mediated disease; persistence; safety
PMID: 26176592 [PubMed - as supplied by publisher]