Abstract
BackgroundPandemic influenza vaccine manufacturing capacity and distribution agility is enhanced through the availability of equivalent antigen-sparing vaccines. We evaluated equivalence in terms of immunogenicity between GlaxoSmithKline Vaccines’ A/California/7/2009 (H1N1)v-like-AS03 vaccines manufactured in Dresden (D-Pan), and Quebec (Q-Pan).MethodsIn two studies, 334 adults 18-60 years of age received 2 doses of D-Pan or Q-Pan containing 3.75 μg haemagglutinin antigen (HA) adjuvanted with AS03A administered 21 days apart, and 209 children 3-9 years of age received 1 reduced dose of D-Panor Q-Pan (0.9 μg HA) or Q-Pan (1.9 μg HA) with AS03B. Haemagglutination inhibition (HI) titres were assessed before and 21 days post-vaccination. HI persistence was assessed after 12 months in adults and 6 months in children.ResultsPre-defined criteria for immunological equivalence of Q-Pan versus D-Pan were achieved in both populations. After one vaccine dose, ≥97.6% of adults and children had HI titres ≥1:40, with increases in titre ≥25.7-fold. CHMP and CBER regulatory acceptance criteria for influenza vaccines were exceeded by all groups in both studies at Day 21. In adults,the percentage with HI titres ≥1:40 at Month 12 was 82.9% (Q-Pan) and 84.0% (D-Pan). In children, the percentages at Month 6 were 75.3.3% (Q-Pan0.9), 85.1% (D-Pan0.9) and 79.3% (Q-Pan1.9). Safety profile of the study vaccines was consistent with previously published data.ConclusionTwo studies indicate that A/California/7/2009 (H1N1)v-like HA manufactured at two sites and combined with AS03 are equivalent in terms of immunogenicity in adults and children and highly immunogenic. Different HA doses elicited an adequate immune response through 180 days post-vaccination in children 3-9 years of age.Trial registrationClinicalTrials.gov: NCT00979407 and NCT01161160.
Highlights
Pandemic influenza vaccine manufacturing capacity and distribution agility is enhanced through the availability of equivalent antigen-sparing vaccines
We report the results of two clinical studies conducted with Dresden is licensed as PandemrixTM (D-Pan) and A/H1N1/2009-AS03 vaccine manufactured in Quebec (Q-Pan) H1N1 vaccines that confirmed the equivalence of the two vaccines in terms of immunogenicity in adults and children, and assessed the feasibility of further antigen sparing in children
Immunogenicity in adults The primary and secondary objectives of the adult study were met: the pre-defined criteria for equivalence of QPan and D-Pan vaccines were achieved at Day 21 and at Day 42 (Table 3)
Summary
Pandemic influenza vaccine manufacturing capacity and distribution agility is enhanced through the availability of equivalent antigen-sparing vaccines. We evaluated equivalence in terms of immunogenicity between GlaxoSmithKline Vaccines’ A/California/7/2009 (H1N1)v-like-AS03 vaccines manufactured in Dresden (D-Pan), and Quebec (Q-Pan). Global influenza antigen manufacturing capacity is limited, and the formulation of H1N1 vaccines with oil-in-water adjuvants using reduced amounts of virus antigen match or surpass immunogenicity compared to unadjuvanted formulations allowing for an increased number of doses from the available antigen bulk (antigen sparing). GlaxoSmithKline Vaccines’ A/California/ 7/2009 (H1N1)v-like vaccine contains the proprietary Adjuvant System 03 (AS03) which allows a 4-fold reduction in the amount of haemagglutinin antigen (HA) necessary to achieve an adequate immune response in adults [5,6]. A single dose containing half of the adult dose (1.9 μg HA) was recommended for children 6 months to 10 years of age [11]
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