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Article: Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine

TitleSafety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine
Authors
Issue Date2012
PublisherElsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/vaccine
Citation
Vaccine, 2012, v. 30 n. 2, p. 329-335 How to Cite?
AbstractA successful vaccine development strategy for areas with clustered H5N1 events requires conduct of vaccine trials in potentially non-naïve subjects and evaluation of post-vaccination responsiveness. An open-label, randomized, phase I/II study therefore assessed the immunogenicity and safety of two different dose levels of an inactivated, non-adjuvanted, whole virus clade 2.1 (A/Indonesia/05/2005) H5N1 Vero cell-derived influenza vaccine in healthy adults (21-45 years) from a region where the virus has been circulating (Hong Kong) as well as Singapore. Subjects (N=110) were randomized 1:1 to receive two vaccinations with either 3.75μg or 7.5μg H5N1 haemagglutinin antigen 21 days apart. Safety, immunogenicity (microneutralization [MN] and single radial haemolysis [SRH] at baseline and post-vaccination) and cross-reactivity against a heterologous clade 1 strain (A/Vietnam/1203/2004) of the vaccine were assessed. Pre-existing immunity to the vaccine strain was 14% which is higher than previously reported for these regions. Two vaccinations with either vaccine formulation induced high seroprotection rates (MN titre ≥ 1:20) against the vaccine strain A/Indonesia/05/2005: 82.7% and 86.5% in the 3.75μg and 7.5μg dose groups. Seroconversion rates and fold increase exceeded the CPMP criterion of >40% and >2.5 for MN and SRH in both dose groups after the second vaccination, while the seroprotection rate in the 7.5μg dose group determined by SRH was only marginally lower (69.2%) than the CPMP criterion of >70%. Thus, 11 of 12 CHMP criteria were fulfilled. A cross-reactive antibody response against the heterologous A/Vietnam/1203/2004 strain was demonstrated after the second vaccination (>21% by MN and ≥25% by SRH). Persistence of antibodies against the vaccine strain was also demonstrated 6 months after the first vaccination, indicating that a booster vaccination would be effective in those who have received two priming doses. No serious adverse events were reported. The H5N1 influenza vaccine against clade 2.1 strain A/Indonesia/05/2005 was well tolerated and immunogenic after two vaccinations, and induced a cross-neutralizing antibody response, with no dose effect. © 2011 Elsevier Ltd.
Persistent Identifierhttp://hdl.handle.net/10722/157665
ISSN
2015 Impact Factor: 3.413
2015 SCImago Journal Rankings: 2.044
ISI Accession Number ID
Funding AgencyGrant Number
Baxter
Baxter AG, Vienna, Austria
Funding Information:

Fritsch S, Loew-Baselli A, Aichinger G, Van der Velden MVW, Maritsch F, Barrett PN, Kistner O, Pavlova BC, Ehrlich HJ are Baxter employees and have received Baxter stocks and stock options; Kistner O and Barrett PN have patents on Vero cell-derived flu vaccines. Tambyah P. Oh MLH, Yuen and Hui have received research fees by Baxter. Funding: The study was sponsored by Baxter AG, Vienna, Austria. Baxter manufactured and provided the study vaccine. The study was designed by its sponsor. Data were collected by the investigators and analyzed by Baxter. The manuscript was written by a subgroup of industry and academic authors; all authors contributed to the content, and had full access to the data.

References

 

DC FieldValueLanguage
dc.contributor.authorTambyah, PAen_US
dc.contributor.authorWilderSmith, Aen_US
dc.contributor.authorPavlova, BGen_US
dc.contributor.authorBarrett, PNen_US
dc.contributor.authorOh, HMLen_US
dc.contributor.authorHui, DSen_US
dc.contributor.authorYuen, KYen_US
dc.contributor.authorFritsch, Sen_US
dc.contributor.authorAichinger, Gen_US
dc.contributor.authorLoewBaselli, Aen_US
dc.contributor.authorVan Der Velden, Men_US
dc.contributor.authorMaritsch, Fen_US
dc.contributor.authorKistner, Oen_US
dc.contributor.authorEhrlich, HJen_US
dc.date.accessioned2012-08-08T08:52:04Z-
dc.date.available2012-08-08T08:52:04Z-
dc.date.issued2012en_US
dc.identifier.citationVaccine, 2012, v. 30 n. 2, p. 329-335en_US
dc.identifier.issn0264-410Xen_US
dc.identifier.urihttp://hdl.handle.net/10722/157665-
dc.description.abstractA successful vaccine development strategy for areas with clustered H5N1 events requires conduct of vaccine trials in potentially non-naïve subjects and evaluation of post-vaccination responsiveness. An open-label, randomized, phase I/II study therefore assessed the immunogenicity and safety of two different dose levels of an inactivated, non-adjuvanted, whole virus clade 2.1 (A/Indonesia/05/2005) H5N1 Vero cell-derived influenza vaccine in healthy adults (21-45 years) from a region where the virus has been circulating (Hong Kong) as well as Singapore. Subjects (N=110) were randomized 1:1 to receive two vaccinations with either 3.75μg or 7.5μg H5N1 haemagglutinin antigen 21 days apart. Safety, immunogenicity (microneutralization [MN] and single radial haemolysis [SRH] at baseline and post-vaccination) and cross-reactivity against a heterologous clade 1 strain (A/Vietnam/1203/2004) of the vaccine were assessed. Pre-existing immunity to the vaccine strain was 14% which is higher than previously reported for these regions. Two vaccinations with either vaccine formulation induced high seroprotection rates (MN titre ≥ 1:20) against the vaccine strain A/Indonesia/05/2005: 82.7% and 86.5% in the 3.75μg and 7.5μg dose groups. Seroconversion rates and fold increase exceeded the CPMP criterion of >40% and >2.5 for MN and SRH in both dose groups after the second vaccination, while the seroprotection rate in the 7.5μg dose group determined by SRH was only marginally lower (69.2%) than the CPMP criterion of >70%. Thus, 11 of 12 CHMP criteria were fulfilled. A cross-reactive antibody response against the heterologous A/Vietnam/1203/2004 strain was demonstrated after the second vaccination (>21% by MN and ≥25% by SRH). Persistence of antibodies against the vaccine strain was also demonstrated 6 months after the first vaccination, indicating that a booster vaccination would be effective in those who have received two priming doses. No serious adverse events were reported. The H5N1 influenza vaccine against clade 2.1 strain A/Indonesia/05/2005 was well tolerated and immunogenic after two vaccinations, and induced a cross-neutralizing antibody response, with no dose effect. © 2011 Elsevier Ltd.en_US
dc.languageengen_US
dc.publisherElsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/vaccineen_US
dc.relation.ispartofVaccineen_US
dc.subject.meshAdulten_US
dc.subject.meshAnimalsen_US
dc.subject.meshAntibodies, Viral - Blooden_US
dc.subject.meshCercopithecus Aethiopsen_US
dc.subject.meshCross Reactionsen_US
dc.subject.meshHong Kongen_US
dc.subject.meshHumansen_US
dc.subject.meshImmunoassayen_US
dc.subject.meshInfluenza A Virus, H5n1 Subtype - Growth & Development - Immunologyen_US
dc.subject.meshInfluenza Vaccines - Administration & Dosage - Adverse Effects - Immunologyen_US
dc.subject.meshInfluenza, Human - Immunology - Prevention & Controlen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshSingaporeen_US
dc.subject.meshVaccination - Adverse Effects - Methodsen_US
dc.subject.meshVero Cellsen_US
dc.titleSafety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccineen_US
dc.typeArticleen_US
dc.identifier.emailYuen, KY:kyyuen@hkucc.hku.hken_US
dc.identifier.authorityYuen, KY=rp00366en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1016/j.vaccine.2011.10.088en_US
dc.identifier.pmid22080174-
dc.identifier.scopuseid_2-s2.0-84355166474en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84355166474&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume30en_US
dc.identifier.issue2en_US
dc.identifier.spage329en_US
dc.identifier.epage335en_US
dc.identifier.isiWOS:000299971800033-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridTambyah, PA=35499886400en_US
dc.identifier.scopusauthoridWilderSmith, A=35509574300en_US
dc.identifier.scopusauthoridPavlova, BG=6603642513en_US
dc.identifier.scopusauthoridBarrett, PN=7202120410en_US
dc.identifier.scopusauthoridOh, HML=7402325915en_US
dc.identifier.scopusauthoridHui, DS=7101862411en_US
dc.identifier.scopusauthoridYuen, KY=36078079100en_US
dc.identifier.scopusauthoridFritsch, S=7005125127en_US
dc.identifier.scopusauthoridAichinger, G=6602679356en_US
dc.identifier.scopusauthoridLoewBaselli, A=6507991775en_US
dc.identifier.scopusauthoridvan der Velden, M=35171663200en_US
dc.identifier.scopusauthoridMaritsch, F=16177952800en_US
dc.identifier.scopusauthoridKistner, O=6701753688en_US
dc.identifier.scopusauthoridEhrlich, HJ=7102414818en_US
dc.identifier.citeulike10030795-

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