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

URN zum Zitieren dieses Dokuments:

urn:nbn:de:bvb:355-epub-375200 Copy

DOI zum Zitieren dieses Dokuments:

10.5283/epub.37520 Copy

Launay, Odile ; Duval, Xavier ; Fitoussi, Serge ; Jilg, Wolfgang ; Kerdpanich, Angkool ; Montellano, May ; Schwarz, Tino F. ; Watanveerade, Veerachai ; Wenzel, Jürgen J. ; Zalcman, Gerard ; Bambure, Vinod ; Li, Ping ; Caplanusi, Adrian ; Madan, Anuradha ; Gillard, Paul ; Vaughn, David W.

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Veröffentlichungsdatum dieses Volltextes: 13 Aug 2018 13:04

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Details

Dokumentenart:	Artikel
Open Access Art:	Gold (mit APC - nicht UR)
Titel eines Journals oder einer Zeitschrift:	BMC Infectious Diseases
Verlag:	Biomed Central
Band:	13
Nummer des Zeitschriftenheftes oder des Kapitels:	1
Datum:	2013
Institutionen:	Medizin > Lehrstuhl für Medizinische Mikrobiologie und Hygiene
Identifikationsnummer:	Wert Typ 10.1186/1471-2334-13-435 DOI
Stichwörter / Keywords:	H1N1, Pandemic influenza vaccine, Influenza virus, Children, Adults, Persistence, Immunogenicity, Manufacturing capacity, Antigen dose reduction
Dewey-Dezimal-Klassifikation:	600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin
Status:	Veröffentlicht
Begutachtet:	Ja, diese Version wurde begutachtet
An der Universität Regensburg entstanden:	Zum Teil
Dokumenten-ID:	37520

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Zusammenfassung

Background 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). Methods In two studies, 334 adults 18-60 years ...

Zusammenfassung

Background
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).
Methods
In 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.
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 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.

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