Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.

Odile Launay 1, 2, * Xavier Duval 3 Serge Fitoussi 4 Wolfgang Jilg 5 Angkool Kerdpanich 6 May Montellano 7 Tino Schwarz 8 Veerachai Watanveerade 6 Jürgen Wenzel 5 Gerard Zalcman 9 Vinod Bambure 10 Ping Li 11 Adrian Caplanusi 12 Anuradha Madan 11 Paul Gillard 12 David Vaughn 11
* Auteur correspondant
1 REIVAC - REseau national d'Investigation clinique en VACcinologie
2 CIC - Biotherapie - AP-HP (cochin - Pasteur)
3 CIC - CHU Bichat
4 Essais Cliniques de Phase 1 à 2A
5 Institute of Medical Microbiology and Hygiene
6 Infectious Diseases Unit
7 Department of Pediatrics
8 Central Laboratory and Vaccination Centre
9 Centre de Recherche Clinique
10 GlaxoSmithKline Vaccines [Bangalore]
11 GlaxoSmithKline Vaccines [King of Prussia]
12 GlaxoSmithKline Vaccines [Wavre]
Abstract : BACKGROUND: Pandemicinfluenza vaccinemanufacturing capacity and distribution agility is enhanced through the availabilityof 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). METHODS: In two studies,334 adults 18-60 years of age received 2 doses of D-Pan or Q-Pan containing 3.75 mug haemagglutinin antigen (HA) adjuvanted with AS03Aadministered21 days apart, and 209 children 3-9 years of age received 1reduced dose of D-Panor Q-Pan (0.9 mug HA) or Q-Pan (1.9 mug 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. RESULTS: Pre-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. CONCLUSION: Two studies indicate that A/California/7/2009 (H1N1)v-like HA manufactured at two sitesand 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.
Keywords : H1N1 Pandemic influenza vaccine Influenza virus Children Adults Persistence Immunogenicity Manufacturing capacity Antigen dose reduction
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BMC Infectious Diseases, BioMed Central, 2013, 13 (1), pp.435. 〈10.1186/1471-2334-13-435〉
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Odile Launay, Xavier Duval, Serge Fitoussi, Wolfgang Jilg, Angkool Kerdpanich, et al.. Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.. BMC Infectious Diseases, BioMed Central, 2013, 13 (1), pp.435. 〈10.1186/1471-2334-13-435〉. 〈inserm-00868824〉

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