tetano
Editor, Senior Moderator
J Infect Dis. (2014) doi: 10.1093/infdis/jiu173 First published online: March 20, 2014
Relative Efficacy of AS03-adjuvanted Pandemic H1N1 Influenza Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial
Terry Nolan1,a,
Sumita Roy-Ghanta2,a,
May Montellano3,
Lily Weckx4,
Rolando Ulloa-Gutierrez5,
Eduardo Lazcano-Ponce6,
Angkool Kerdpanich7,
Marco Aurélio Palazzi Safadi8,
Aurelio Cruz-Valdez9,
Sandra Litao10,
Lim Fong Seng11,
Abiel Mascareñas de Los Santos12,
Miguel Angel Rodriguez Weber13,
Juan-Carlos Tinoco14,
Marcela Hernandez-de Mezerville15,
Idis Faingezicht16,
Pensri Kosuwon17,
Pio Lopez18,
Charissa Borja-Tabora19,
Ping Li2,
Serge Durviaux20,
Louis Fries21,
Gary Dubin2,
Thomas Breuer20,
Bruce L. Innis2 and
David W. Vaughn22
Correspondence: Prof Terry Nolan, Melbourne School of Population and Global Health, University of Melbourne, Level 5, 207 Bouverie Street, Carlton, Victoria 3010, Australia (t.nolan{at}unimelb.edu.au).
Presentation at meetings: These data have not been presented at a congress.
↵a T. N.and S. R.-G. contributed equally to this work and are listed in alphabetical order.
Abstract
Background. Relative vaccine efficacy (rVE) after one or two doses of AS03-adjuvanted H1N1 vaccine was compared with two doses of non-adjuvanted H1N1 vaccine in children 6 months to <10 years of age in a multinational study conducted in 2010–2011 (www.clinicaltrials.gov NCT01051661).
Methods. 6145 children were randomized (1:1:1) to receive two injections 21 days apart of either A/California/7/2009-H1N1-AS03 vaccine at dose 1 and saline placebo at dose 2 (Ad1 group), two doses of A/California/7/2009-H1N1-AS03 vaccine (Ad2), or two doses of non-adjuvanted A/California/7/2009-H1N1 vaccine (NAd2). Active surveillance for influenza-like illnesses continued from day 14–385. Nose/throat samples during influenza-like illnesses were tested for A/California/7/2009-H1N1 using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity and safety were assessed.
Results. There were 23 cases of confirmed H1N1 influenza for the primary rVE analysis. Superior vaccine efficacy was demonstrated for the Ad2 over the NAd2 group: rVE 76.8% (95% CI, 18.5%–93.4%). Adjuvant benefit was demonstrated in terms of immunogenicity in the Ad2 vs NAd2 groups.
Conclusion. The 4–8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of H1N1 influenza disease compared with non-adjuvanted vaccine, with no observed increase in medically-attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics.
http://jid.oxfordjournals.org/content/early/2014/03/20/infdis.jiu173.short
full
http://jid.oxfordjournals.org/content/early/2014/03/20/infdis.jiu173.full.pdf+html
Relative Efficacy of AS03-adjuvanted Pandemic H1N1 Influenza Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial
Terry Nolan1,a,
Sumita Roy-Ghanta2,a,
May Montellano3,
Lily Weckx4,
Rolando Ulloa-Gutierrez5,
Eduardo Lazcano-Ponce6,
Angkool Kerdpanich7,
Marco Aurélio Palazzi Safadi8,
Aurelio Cruz-Valdez9,
Sandra Litao10,
Lim Fong Seng11,
Abiel Mascareñas de Los Santos12,
Miguel Angel Rodriguez Weber13,
Juan-Carlos Tinoco14,
Marcela Hernandez-de Mezerville15,
Idis Faingezicht16,
Pensri Kosuwon17,
Pio Lopez18,
Charissa Borja-Tabora19,
Ping Li2,
Serge Durviaux20,
Louis Fries21,
Gary Dubin2,
Thomas Breuer20,
Bruce L. Innis2 and
David W. Vaughn22
Correspondence: Prof Terry Nolan, Melbourne School of Population and Global Health, University of Melbourne, Level 5, 207 Bouverie Street, Carlton, Victoria 3010, Australia (t.nolan{at}unimelb.edu.au).
Presentation at meetings: These data have not been presented at a congress.
↵a T. N.and S. R.-G. contributed equally to this work and are listed in alphabetical order.
Abstract
Background. Relative vaccine efficacy (rVE) after one or two doses of AS03-adjuvanted H1N1 vaccine was compared with two doses of non-adjuvanted H1N1 vaccine in children 6 months to <10 years of age in a multinational study conducted in 2010–2011 (www.clinicaltrials.gov NCT01051661).
Methods. 6145 children were randomized (1:1:1) to receive two injections 21 days apart of either A/California/7/2009-H1N1-AS03 vaccine at dose 1 and saline placebo at dose 2 (Ad1 group), two doses of A/California/7/2009-H1N1-AS03 vaccine (Ad2), or two doses of non-adjuvanted A/California/7/2009-H1N1 vaccine (NAd2). Active surveillance for influenza-like illnesses continued from day 14–385. Nose/throat samples during influenza-like illnesses were tested for A/California/7/2009-H1N1 using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity and safety were assessed.
Results. There were 23 cases of confirmed H1N1 influenza for the primary rVE analysis. Superior vaccine efficacy was demonstrated for the Ad2 over the NAd2 group: rVE 76.8% (95% CI, 18.5%–93.4%). Adjuvant benefit was demonstrated in terms of immunogenicity in the Ad2 vs NAd2 groups.
Conclusion. The 4–8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of H1N1 influenza disease compared with non-adjuvanted vaccine, with no observed increase in medically-attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics.
http://jid.oxfordjournals.org/content/early/2014/03/20/infdis.jiu173.short
full
http://jid.oxfordjournals.org/content/early/2014/03/20/infdis.jiu173.full.pdf+html