tetano
Editor, Senior Moderator
Vaccine. 2015 Apr 21. pii: S0264-410X(15)00480-6. doi: 10.1016/j.vaccine.2015.04.027. [Epub ahead of print]
[h=1]Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: A phase IV, randomized, open-label, controlled study.[/h] Izurieta P[SUP]1[/SUP], Kim WJ[SUP]2[/SUP], Wie SH[SUP]3[/SUP], Lee J[SUP]4[/SUP], Lee JS[SUP]5[/SUP], Dram? M[SUP]6[/SUP], Vaughn DW[SUP]6[/SUP], Schuind A[SUP]6[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] AS03-adjuvanted H5N1 pandemic influenza vaccines have been assessed in an extensive clinical development program conducted in North America, Europe, and Asia including children from 6 months of age, adults, and elderly adults. We evaluated AS03-H5N1 in Korean adults 18 through 60 years of age.
[h=4]METHODS:[/h] This Phase IV, randomized, study was conducted to assess the immunogenicity, reactogenicity, and safety of two doses (3.75μg of hemagglutinin antigen) of A/Indonesia/5/2005 (H5N1) adjuvanted with AS03 given 21 days apart in Korean adults. Antibody responses were assessed using hemagglutination-inhibition (HI) assays against the vaccine strain and a vaccine-heterologous strain (A/Vietnam/1194/2004) 21 days after the second dose. A control group (safety) received a licensed seasonal inactivated trivalent influenza vaccine (TIV). Reactogenicity was assessed for 7 days after each vaccination, and unsolicited adverse events were assessed for 182 days following vaccination in both study groups (NCT01730378).
[h=4]RESULTS:[/h] AS03-H5N1 was immunogenic and elicited robust HI antibody responses with seroconversion rates of 100% for the vaccine strain and 69.1% for the heterologous strain (N=81). HI antibody responses fulfilled the European licensure criteria for immunogenicity (primary endpoint). The incidence of local and systemic solicited adverse events (reactogenicity) was higher with AS03-H5N1 than TIV. There was no apparent difference in the rate of unsolicited adverse events in the AS03-H5N1 and TIV groups.
[h=4]CONCLUSION:[/h] The results indicate that AS03-H5N1 vaccine is immunogenic with reactogenicity and safety findings that are consistent with the established profile of AS03-H5N1 vaccine.
Copyright ? 2015. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] AS03; H5N1 vaccine; Korean adults; Pandemic influenza
PMID: 25910919 [PubMed - as supplied by publisher]
[h=1]Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: A phase IV, randomized, open-label, controlled study.[/h] Izurieta P[SUP]1[/SUP], Kim WJ[SUP]2[/SUP], Wie SH[SUP]3[/SUP], Lee J[SUP]4[/SUP], Lee JS[SUP]5[/SUP], Dram? M[SUP]6[/SUP], Vaughn DW[SUP]6[/SUP], Schuind A[SUP]6[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] AS03-adjuvanted H5N1 pandemic influenza vaccines have been assessed in an extensive clinical development program conducted in North America, Europe, and Asia including children from 6 months of age, adults, and elderly adults. We evaluated AS03-H5N1 in Korean adults 18 through 60 years of age.
[h=4]METHODS:[/h] This Phase IV, randomized, study was conducted to assess the immunogenicity, reactogenicity, and safety of two doses (3.75μg of hemagglutinin antigen) of A/Indonesia/5/2005 (H5N1) adjuvanted with AS03 given 21 days apart in Korean adults. Antibody responses were assessed using hemagglutination-inhibition (HI) assays against the vaccine strain and a vaccine-heterologous strain (A/Vietnam/1194/2004) 21 days after the second dose. A control group (safety) received a licensed seasonal inactivated trivalent influenza vaccine (TIV). Reactogenicity was assessed for 7 days after each vaccination, and unsolicited adverse events were assessed for 182 days following vaccination in both study groups (NCT01730378).
[h=4]RESULTS:[/h] AS03-H5N1 was immunogenic and elicited robust HI antibody responses with seroconversion rates of 100% for the vaccine strain and 69.1% for the heterologous strain (N=81). HI antibody responses fulfilled the European licensure criteria for immunogenicity (primary endpoint). The incidence of local and systemic solicited adverse events (reactogenicity) was higher with AS03-H5N1 than TIV. There was no apparent difference in the rate of unsolicited adverse events in the AS03-H5N1 and TIV groups.
[h=4]CONCLUSION:[/h] The results indicate that AS03-H5N1 vaccine is immunogenic with reactogenicity and safety findings that are consistent with the established profile of AS03-H5N1 vaccine.
Copyright ? 2015. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] AS03; H5N1 vaccine; Korean adults; Pandemic influenza
PMID: 25910919 [PubMed - as supplied by publisher]