File Download
There are no files associated with this item.
Links for fulltext
(May Require Subscription)
- Publisher Website: 10.1016/j.vaccine.2011.10.088
- Scopus: eid_2-s2.0-84355166474
- PMID: 22080174
- WOS: WOS:000299971800033
- Find via
Supplementary
- Citations:
- Appears in Collections:
Article: Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine
Title | Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine | ||||||
---|---|---|---|---|---|---|---|
Authors | |||||||
Keywords | Avian influenza H5N1 Immunogenicity Pandemic vaccine PHASE I/II Pre-pandemic vaccine Safety | ||||||
Issue Date | 2012 | ||||||
Publisher | Elsevier 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? | ||||||
Abstract | A 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 Identifier | http://hdl.handle.net/10722/157665 | ||||||
ISSN | 2023 Impact Factor: 4.5 2023 SCImago Journal Rankings: 1.342 | ||||||
ISI Accession Number ID |
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 Field | Value | Language |
---|---|---|
dc.contributor.author | Tambyah, PA | en_US |
dc.contributor.author | WilderSmith, A | en_US |
dc.contributor.author | Pavlova, BG | en_US |
dc.contributor.author | Barrett, PN | en_US |
dc.contributor.author | Oh, HML | en_US |
dc.contributor.author | Hui, DS | en_US |
dc.contributor.author | Yuen, KY | en_US |
dc.contributor.author | Fritsch, S | en_US |
dc.contributor.author | Aichinger, G | en_US |
dc.contributor.author | LoewBaselli, A | en_US |
dc.contributor.author | Van Der Velden, M | en_US |
dc.contributor.author | Maritsch, F | en_US |
dc.contributor.author | Kistner, O | en_US |
dc.contributor.author | Ehrlich, HJ | en_US |
dc.date.accessioned | 2012-08-08T08:52:04Z | - |
dc.date.available | 2012-08-08T08:52:04Z | - |
dc.date.issued | 2012 | en_US |
dc.identifier.citation | Vaccine, 2012, v. 30 n. 2, p. 329-335 | en_US |
dc.identifier.issn | 0264-410X | en_US |
dc.identifier.uri | http://hdl.handle.net/10722/157665 | - |
dc.description.abstract | A 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.language | eng | en_US |
dc.publisher | Elsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/vaccine | en_US |
dc.relation.ispartof | Vaccine | en_US |
dc.subject | Avian influenza | - |
dc.subject | H5N1 | - |
dc.subject | Immunogenicity | - |
dc.subject | Pandemic vaccine | - |
dc.subject | PHASE I/II | - |
dc.subject | Pre-pandemic vaccine | - |
dc.subject | Safety | - |
dc.subject.mesh | Adult | en_US |
dc.subject.mesh | Animals | en_US |
dc.subject.mesh | Antibodies, Viral - Blood | en_US |
dc.subject.mesh | Cercopithecus Aethiops | en_US |
dc.subject.mesh | Cross Reactions | en_US |
dc.subject.mesh | Hong Kong | en_US |
dc.subject.mesh | Humans | en_US |
dc.subject.mesh | Immunoassay | en_US |
dc.subject.mesh | Influenza A Virus, H5n1 Subtype - Growth & Development - Immunology | en_US |
dc.subject.mesh | Influenza Vaccines - Administration & Dosage - Adverse Effects - Immunology | en_US |
dc.subject.mesh | Influenza, Human - Immunology - Prevention & Control | en_US |
dc.subject.mesh | Middle Aged | en_US |
dc.subject.mesh | Singapore | en_US |
dc.subject.mesh | Vaccination - Adverse Effects - Methods | en_US |
dc.subject.mesh | Vero Cells | en_US |
dc.title | Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine | en_US |
dc.type | Article | en_US |
dc.identifier.email | Yuen, KY:kyyuen@hkucc.hku.hk | en_US |
dc.identifier.authority | Yuen, KY=rp00366 | en_US |
dc.description.nature | link_to_subscribed_fulltext | en_US |
dc.identifier.doi | 10.1016/j.vaccine.2011.10.088 | en_US |
dc.identifier.pmid | 22080174 | - |
dc.identifier.scopus | eid_2-s2.0-84355166474 | en_US |
dc.relation.references | http://www.scopus.com/mlt/select.url?eid=2-s2.0-84355166474&selection=ref&src=s&origin=recordpage | en_US |
dc.identifier.volume | 30 | en_US |
dc.identifier.issue | 2 | en_US |
dc.identifier.spage | 329 | en_US |
dc.identifier.epage | 335 | en_US |
dc.identifier.isi | WOS:000299971800033 | - |
dc.publisher.place | United Kingdom | en_US |
dc.identifier.scopusauthorid | Tambyah, PA=35499886400 | en_US |
dc.identifier.scopusauthorid | WilderSmith, A=35509574300 | en_US |
dc.identifier.scopusauthorid | Pavlova, BG=6603642513 | en_US |
dc.identifier.scopusauthorid | Barrett, PN=7202120410 | en_US |
dc.identifier.scopusauthorid | Oh, HML=7402325915 | en_US |
dc.identifier.scopusauthorid | Hui, DS=7101862411 | en_US |
dc.identifier.scopusauthorid | Yuen, KY=36078079100 | en_US |
dc.identifier.scopusauthorid | Fritsch, S=7005125127 | en_US |
dc.identifier.scopusauthorid | Aichinger, G=6602679356 | en_US |
dc.identifier.scopusauthorid | LoewBaselli, A=6507991775 | en_US |
dc.identifier.scopusauthorid | van der Velden, M=35171663200 | en_US |
dc.identifier.scopusauthorid | Maritsch, F=16177952800 | en_US |
dc.identifier.scopusauthorid | Kistner, O=6701753688 | en_US |
dc.identifier.scopusauthorid | Ehrlich, HJ=7102414818 | en_US |
dc.identifier.citeulike | 10030795 | - |
dc.identifier.issnl | 0264-410X | - |