tetano
Editor, Senior Moderator
J Infect Dis. 2015 Feb 25. pii: jiv091. [Epub ahead of print]
[h=1]Immunogenicity and safety of an EB66 cell-culture-derived A/Indonesia/5/2005 (H5N1)-AS03-adjuvanted influenza vaccine: Phase-I randomized trial.[/h] Schuind A[SUP]1[/SUP], Segall N[SUP]2[/SUP], Drame M[SUP]1[/SUP], Innis BL[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Cell-culture-derived (CC) influenza vaccine production methods could provide benefits over classical embryonated-egg technology including higher capacity and faster supply. Methods. A CC-inactivated split-virus influenza A/Indonesia/5/2005-H5N1 vaccine derived from the EB66 cell-line was investigated in a Phase-I randomized, blinded study (www.ClinicalTrials.gov; NCT01236040). Healthy adults (N=521) received two vaccine doses (days 0, 21) of either: investigational CC-H5N1 vaccine (1.9 ?g or 3.75 ?g hemagglutinin antigen [HA] with AS03 adjuvant system, or 15 ?g plain HA), embryonated-egg-derived vaccines (3.75 ?g HA with AS03, or 15 ?g plain HA), or placebo. Assessment of the adjuvant effect and immunogenicity used Center for Biologics Evaluation and Research acceptability criteria 21 days post-dose-2. Safety was assessed until month 12.
[h=4]RESULTS:[/h] CC-H5N1-AS03-adjuvanted vaccine elicited homologous hemagglutination inhibition antibody response satisfying immunogenicity criteria 21 days post-dose-2 and persisting at month 12. Adjuvant effect and immune response against a drift-variant strain were demonstrated. No vaccine-related serious adverse events were reported. Immunogenicity and safety of the CC-3.75 ?gHA-AS03 formulation appeared similar to the licensed egg-derived-AS03-adjuvanted control.
[h=4]CONCLUSIONS:[/h] The feasibility of the EB66 cell-line to produce an immunogenic influenza vaccine with acceptable safety profile was demonstrated. Antigen-sparing was achieved through combination with AS03-adjuvant. This CC-H5N1 vaccine might contribute to rapid vaccine access in the event of pandemic. NCT number. NCT01236040.
? The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
PMID: 25722291 [PubMed - as supplied by publisher]
[h=1]Immunogenicity and safety of an EB66 cell-culture-derived A/Indonesia/5/2005 (H5N1)-AS03-adjuvanted influenza vaccine: Phase-I randomized trial.[/h] Schuind A[SUP]1[/SUP], Segall N[SUP]2[/SUP], Drame M[SUP]1[/SUP], Innis BL[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Cell-culture-derived (CC) influenza vaccine production methods could provide benefits over classical embryonated-egg technology including higher capacity and faster supply. Methods. A CC-inactivated split-virus influenza A/Indonesia/5/2005-H5N1 vaccine derived from the EB66 cell-line was investigated in a Phase-I randomized, blinded study (www.ClinicalTrials.gov; NCT01236040). Healthy adults (N=521) received two vaccine doses (days 0, 21) of either: investigational CC-H5N1 vaccine (1.9 ?g or 3.75 ?g hemagglutinin antigen [HA] with AS03 adjuvant system, or 15 ?g plain HA), embryonated-egg-derived vaccines (3.75 ?g HA with AS03, or 15 ?g plain HA), or placebo. Assessment of the adjuvant effect and immunogenicity used Center for Biologics Evaluation and Research acceptability criteria 21 days post-dose-2. Safety was assessed until month 12.
[h=4]RESULTS:[/h] CC-H5N1-AS03-adjuvanted vaccine elicited homologous hemagglutination inhibition antibody response satisfying immunogenicity criteria 21 days post-dose-2 and persisting at month 12. Adjuvant effect and immune response against a drift-variant strain were demonstrated. No vaccine-related serious adverse events were reported. Immunogenicity and safety of the CC-3.75 ?gHA-AS03 formulation appeared similar to the licensed egg-derived-AS03-adjuvanted control.
[h=4]CONCLUSIONS:[/h] The feasibility of the EB66 cell-line to produce an immunogenic influenza vaccine with acceptable safety profile was demonstrated. Antigen-sparing was achieved through combination with AS03-adjuvant. This CC-H5N1 vaccine might contribute to rapid vaccine access in the event of pandemic. NCT number. NCT01236040.
? The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
PMID: 25722291 [PubMed - as supplied by publisher]