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Priming with AS03 A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomised primary study.
Vaccine. 2010 Jan 08; 28(3):849-57.V

Abstract

An influenza vaccine with cross-immunogenic potential could play a key role in pandemic mitigation by promoting a rapid immune response to infection and/or subsequent vaccination with strains drifted from the primary vaccine strain. Here we assess the role of AS03(A) (an oil-in-water emulsion based Adjuvant System containing tocopherol) in this prime-boost concept using H5N1 as a model shift influenza antigen. In this open, non-randomised study (NCT00506350; an extension of an earlier randomised study) we assessed immunogenicity in nine groups of 35-50 volunteers aged 19-61 years following administration of AS03(A)-adjuvanted split-virion H5N1 vaccine containing 3.75mug of haemagglutinin (HA) from the A/Indonesia/5/2005(IBCDC-RG2) clade 2.1 strain. A single booster dose of vaccine was administered to four groups primed 14 months previously with different HA levels of AS03(A)-adjuvanted clade 1 A/Vietnam/1194/2004 H5N1 vaccine. Two booster doses (given 21 days apart) were administered to four groups primed 14 months previously with different HA levels of non-adjuvanted A/Vietnam/1194/2004 H5N1 vaccine and also to a control group of un-primed subjects. In individuals primed 14 months earlier with AS03(A)-adjuvanted A/Vietnam/1194/2004 vaccines, a single booster dose of AS03(A)-adjuvanted A/Indonesia/5/2005 induced rapid immune responses (licensure criteria met in 7-14 days) comparable to that observed in the un-primed control group following two doses of adjuvanted vaccine. In contrast, individuals primed with non-adjuvanted formulations exhibited minimal immune responses which, even after two doses, were unexpectedly much lower than that observed in un-primed subjects. AS03(A) enhances the initial priming effect of pandemic influenza vaccination enabling a rapid humoral response to single dose boosting with a heterologous strain at 14 months. In contrast, priming without adjuvant appears to inhibit the response to subsequent vaccination with a heterologous strain. These findings should guide the development of vaccines to combat the present influenza A/H1N1 pandemic.

Authors+Show Affiliations

Center for Vaccinology, Ghent University and Hospital, De Pintelaan 185, 9000 Ghent, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

19835828

Citation

Leroux-Roels, Isabel, et al. "Priming With AS03 A-adjuvanted H5N1 Influenza Vaccine Improves the Kinetics, Magnitude and Durability of the Immune Response After a Heterologous Booster Vaccination: an Open Non-randomised Extension of a Double-blind Randomised Primary Study." Vaccine, vol. 28, no. 3, 2010, pp. 849-57.
Leroux-Roels I, Roman F, Forgus S, et al. Priming with AS03 A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomised primary study. Vaccine. 2010;28(3):849-57.
Leroux-Roels, I., Roman, F., Forgus, S., Maes, C., De Boever, F., Dramé, M., Gillard, P., van der Most, R., Van Mechelen, M., Hanon, E., & Leroux-Roels, G. (2010). Priming with AS03 A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomised primary study. Vaccine, 28(3), 849-57. https://doi.org/10.1016/j.vaccine.2009.10.017
Leroux-Roels I, et al. Priming With AS03 A-adjuvanted H5N1 Influenza Vaccine Improves the Kinetics, Magnitude and Durability of the Immune Response After a Heterologous Booster Vaccination: an Open Non-randomised Extension of a Double-blind Randomised Primary Study. Vaccine. 2010 Jan 8;28(3):849-57. PubMed PMID: 19835828.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Priming with AS03 A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomised primary study. AU - Leroux-Roels,Isabel, AU - Roman,François, AU - Forgus,Sheron, AU - Maes,Cathy, AU - De Boever,Fien, AU - Dramé,Mamadou, AU - Gillard,Paul, AU - van der Most,Robbert, AU - Van Mechelen,Marcelle, AU - Hanon,Emmanuel, AU - Leroux-Roels,Geert, Y1 - 2009/10/14/ PY - 2009/08/11/received PY - 2009/09/27/revised PY - 2009/10/05/accepted PY - 2009/10/20/entrez PY - 2009/10/20/pubmed PY - 2010/2/4/medline SP - 849 EP - 57 JF - Vaccine JO - Vaccine VL - 28 IS - 3 N2 - An influenza vaccine with cross-immunogenic potential could play a key role in pandemic mitigation by promoting a rapid immune response to infection and/or subsequent vaccination with strains drifted from the primary vaccine strain. Here we assess the role of AS03(A) (an oil-in-water emulsion based Adjuvant System containing tocopherol) in this prime-boost concept using H5N1 as a model shift influenza antigen. In this open, non-randomised study (NCT00506350; an extension of an earlier randomised study) we assessed immunogenicity in nine groups of 35-50 volunteers aged 19-61 years following administration of AS03(A)-adjuvanted split-virion H5N1 vaccine containing 3.75mug of haemagglutinin (HA) from the A/Indonesia/5/2005(IBCDC-RG2) clade 2.1 strain. A single booster dose of vaccine was administered to four groups primed 14 months previously with different HA levels of AS03(A)-adjuvanted clade 1 A/Vietnam/1194/2004 H5N1 vaccine. Two booster doses (given 21 days apart) were administered to four groups primed 14 months previously with different HA levels of non-adjuvanted A/Vietnam/1194/2004 H5N1 vaccine and also to a control group of un-primed subjects. In individuals primed 14 months earlier with AS03(A)-adjuvanted A/Vietnam/1194/2004 vaccines, a single booster dose of AS03(A)-adjuvanted A/Indonesia/5/2005 induced rapid immune responses (licensure criteria met in 7-14 days) comparable to that observed in the un-primed control group following two doses of adjuvanted vaccine. In contrast, individuals primed with non-adjuvanted formulations exhibited minimal immune responses which, even after two doses, were unexpectedly much lower than that observed in un-primed subjects. AS03(A) enhances the initial priming effect of pandemic influenza vaccination enabling a rapid humoral response to single dose boosting with a heterologous strain at 14 months. In contrast, priming without adjuvant appears to inhibit the response to subsequent vaccination with a heterologous strain. These findings should guide the development of vaccines to combat the present influenza A/H1N1 pandemic. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/19835828/Priming_with_AS03_A_adjuvanted_H5N1_influenza_vaccine_improves_the_kinetics_magnitude_and_durability_of_the_immune_response_after_a_heterologous_booster_vaccination:_an_open_non_randomised_extension_of_a_double_blind_randomised_primary_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(09)01532-1 DB - PRIME DP - Unbound Medicine ER -