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Vaccine
Article in Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.08.076 | How to Cite or Link Using DOI
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Predictors of immune response and reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccinesstar, open
Nick J. Andrewsa, Corresponding Author Contact Information, E-mail The Corresponding Author, Woolf T. Walkerb, Adam Finne, Paul T. Heathc, Andrew C. Collinsond, Andrew J. Pollardf, Matthew D. Snapef, Saul N. Faustb, Pauline A. Waighta, Katja Hoschlera, Liz Sheasbya, Claire Waddingtonf, Simon Kerridgef, Jeremy Chalkf, Amanda Reinerf, Tessa Johnf, Margaret Fletchere, Ruth Allene, Natalie Finemane, Su Wilkinsd, Michelle Caseyb, Louise Michaelisb, Clarissa Oeserc, Ifeanyichukwu Okikec, Shamez Ladhania, c and Elizabeth Millera
a Health Protection Agency, Colindale, London NW9 5EQ, UK
b University of Southampton Wellcome Trust Clinical Research Facility, NIHR Respiratory Biomedical Research Unit and Division of Infection, Inflammation & Immunity, Southampton, UK
c St. George's Vaccine Institute, St. Georges, University of London, London, UK
d Royal Devon & Exeter NHS Foundation Trust, Exeter, UK
e Bristol Children's Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and School of Clinical Sciences, University of Bristol, UK
f Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
Received 18 May 2011;
revised 1 August 2011;
accepted 15 August 2011.
Available online 27 August 2011.
Abstract
In 2009, 943 children aged 6 months to 10 years were randomised to receive two doses of an oil-in water AS03B-adjuvanted split virion or a non-adjuvanted whole virion H1N1 (2009) vaccine. The large numbers allowed investigation of possible predictors of immune response and reactogenicity. We used regression analysis to examine the effect of variables including past receipt of seasonal vaccine, antipyretics post-vaccination, interval between doses and pre-existing antibodies to H1N1 (2009) on immunogenicity. We also examined the relationship between immunogenicity and reactogenicity and whether prior infection or underlying conditions affected reactogenicity. For both vaccines, haemagglutination-inhibition titres were 60% higher in children with fever ≥38 ?C after vaccination and 29% lower in those previously given seasonal vaccine. Early use of antipyretics did not affect immunogenicity. Post-vaccination titres were higher with longer intervals between doses and in those with evidence of prior infection, but reactogenicity in the latter was unaffected. In the adjuvanted vaccine group, reactions were more common in children with atopy. Both vaccines were safe and immunogenic in those with prior infection. Reduction in the interval between doses for earlier protection would be at the cost of reduced immunogenicity. The effect of seasonal vaccine on immunogenicity merits further investigation.
Highlights
► Further analysis of results from a trial of two pandemic vaccines was performed. ► Immune response was increased in those with post vaccination fever ≥38 ?C. ► Those with previously given seasonal influenza vaccine had reduced immune responses. ► Immune response was greater with increased interval between doses. ► Atopy was associated with more reactions following adjuvanted vaccine.
http://www.sciencedirect.com/science/article/pii/S0264410X11013351
Article in Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.08.076 | How to Cite or Link Using DOI
Permissions & Reprints
Predictors of immune response and reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccinesstar, open
Nick J. Andrewsa, Corresponding Author Contact Information, E-mail The Corresponding Author, Woolf T. Walkerb, Adam Finne, Paul T. Heathc, Andrew C. Collinsond, Andrew J. Pollardf, Matthew D. Snapef, Saul N. Faustb, Pauline A. Waighta, Katja Hoschlera, Liz Sheasbya, Claire Waddingtonf, Simon Kerridgef, Jeremy Chalkf, Amanda Reinerf, Tessa Johnf, Margaret Fletchere, Ruth Allene, Natalie Finemane, Su Wilkinsd, Michelle Caseyb, Louise Michaelisb, Clarissa Oeserc, Ifeanyichukwu Okikec, Shamez Ladhania, c and Elizabeth Millera
a Health Protection Agency, Colindale, London NW9 5EQ, UK
b University of Southampton Wellcome Trust Clinical Research Facility, NIHR Respiratory Biomedical Research Unit and Division of Infection, Inflammation & Immunity, Southampton, UK
c St. George's Vaccine Institute, St. Georges, University of London, London, UK
d Royal Devon & Exeter NHS Foundation Trust, Exeter, UK
e Bristol Children's Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and School of Clinical Sciences, University of Bristol, UK
f Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
Received 18 May 2011;
revised 1 August 2011;
accepted 15 August 2011.
Available online 27 August 2011.
Abstract
In 2009, 943 children aged 6 months to 10 years were randomised to receive two doses of an oil-in water AS03B-adjuvanted split virion or a non-adjuvanted whole virion H1N1 (2009) vaccine. The large numbers allowed investigation of possible predictors of immune response and reactogenicity. We used regression analysis to examine the effect of variables including past receipt of seasonal vaccine, antipyretics post-vaccination, interval between doses and pre-existing antibodies to H1N1 (2009) on immunogenicity. We also examined the relationship between immunogenicity and reactogenicity and whether prior infection or underlying conditions affected reactogenicity. For both vaccines, haemagglutination-inhibition titres were 60% higher in children with fever ≥38 ?C after vaccination and 29% lower in those previously given seasonal vaccine. Early use of antipyretics did not affect immunogenicity. Post-vaccination titres were higher with longer intervals between doses and in those with evidence of prior infection, but reactogenicity in the latter was unaffected. In the adjuvanted vaccine group, reactions were more common in children with atopy. Both vaccines were safe and immunogenic in those with prior infection. Reduction in the interval between doses for earlier protection would be at the cost of reduced immunogenicity. The effect of seasonal vaccine on immunogenicity merits further investigation.
Highlights
► Further analysis of results from a trial of two pandemic vaccines was performed. ► Immune response was increased in those with post vaccination fever ≥38 ?C. ► Those with previously given seasonal influenza vaccine had reduced immune responses. ► Immune response was greater with increased interval between doses. ► Atopy was associated with more reactions following adjuvanted vaccine.
http://www.sciencedirect.com/science/article/pii/S0264410X11013351