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Pediatr Infect Dis J. 2015 Nov 6. [Epub ahead of print]
Assessment of Prime-Boost Vaccination using an AS03B-Adjuvanted Influenza A(H5N1) Vaccine: A Randomized Trial in Children 3 to less Than 18 Years of Age.
Izurieta P1, Uy-Aragon MJ, Dram? M, Vaughn DW.
Author information
Abstract
BACKGROUND:
Heterologous prime-boost vaccination is a pandemic response strategy utilizing subtype-matched vaccine at pandemic onset followed by strain-matched vaccine once available. Persistence of immune response and safety of influenza A (H5N1) vaccine adjuvanted with AS03B (Adjuvant System containing α-Tocopherol and squalene in an oil-in-water emulsion) were evaluated.
METHODS:
An open Phase 3 active controlled study (www.clinicaltrials.gov NCT01379937) assessed immunogenicity and reactogenicity of a heterologous booster dose of A/turkey/Turkey/1/2005-H5N1-AS03B in children 3<18 years of age, given six months following two-dose priming with A/Indonesia/05/2005-H5N1-AS03B (H5N1(2)-H5N1 group) compared with a single dose of A/turkey/Turkey/1/2005-H5N1-AS03B in unprimed subjects (HAV-H5N1 group). Hemagglutinin inhibition responses and microneutralization antibodies were assessed to 6 months following booster vaccination.
RESULTS:
Hemagglutinin inhibition antibody responses against A/turkey/Turkey/1/2005-H5N1 were superior in the H5N1(2)-H5N1 versus the HAV-H5N1 group overall and in each age strata (3<10 and 10<18 years). Anamnestic immune responses were demonstrated against vaccine-homologous/heterologous strains in the H5N1(2)-H5N1 group. Injection site pain and fever increased with consecutive doses for children <6 years (H5N1(2)-H5N1). Immune responses to vaccine-homologous/heterologous strains persisted to six months following booster vaccination in the H5N1(2)-H5N1 group.
CONCLUSIONS:
Heterologous H5N1-AS03B-adjuvanted booster vaccination in children/adolescents was immunogenic for vaccine-homologous and heterologous strains following two-dose priming, with immune persistence for at least 6 months. Prime-boost strategies using H5N1-AS03 could be effectively employed in this age group.
PMID: 26551446 [PubMed - as supplied by publisher]
Assessment of Prime-Boost Vaccination using an AS03B-Adjuvanted Influenza A(H5N1) Vaccine: A Randomized Trial in Children 3 to less Than 18 Years of Age.
Izurieta P1, Uy-Aragon MJ, Dram? M, Vaughn DW.
Author information
Abstract
BACKGROUND:
Heterologous prime-boost vaccination is a pandemic response strategy utilizing subtype-matched vaccine at pandemic onset followed by strain-matched vaccine once available. Persistence of immune response and safety of influenza A (H5N1) vaccine adjuvanted with AS03B (Adjuvant System containing α-Tocopherol and squalene in an oil-in-water emulsion) were evaluated.
METHODS:
An open Phase 3 active controlled study (www.clinicaltrials.gov NCT01379937) assessed immunogenicity and reactogenicity of a heterologous booster dose of A/turkey/Turkey/1/2005-H5N1-AS03B in children 3<18 years of age, given six months following two-dose priming with A/Indonesia/05/2005-H5N1-AS03B (H5N1(2)-H5N1 group) compared with a single dose of A/turkey/Turkey/1/2005-H5N1-AS03B in unprimed subjects (HAV-H5N1 group). Hemagglutinin inhibition responses and microneutralization antibodies were assessed to 6 months following booster vaccination.
RESULTS:
Hemagglutinin inhibition antibody responses against A/turkey/Turkey/1/2005-H5N1 were superior in the H5N1(2)-H5N1 versus the HAV-H5N1 group overall and in each age strata (3<10 and 10<18 years). Anamnestic immune responses were demonstrated against vaccine-homologous/heterologous strains in the H5N1(2)-H5N1 group. Injection site pain and fever increased with consecutive doses for children <6 years (H5N1(2)-H5N1). Immune responses to vaccine-homologous/heterologous strains persisted to six months following booster vaccination in the H5N1(2)-H5N1 group.
CONCLUSIONS:
Heterologous H5N1-AS03B-adjuvanted booster vaccination in children/adolescents was immunogenic for vaccine-homologous and heterologous strains following two-dose priming, with immune persistence for at least 6 months. Prime-boost strategies using H5N1-AS03 could be effectively employed in this age group.
PMID: 26551446 [PubMed - as supplied by publisher]