Tags

Type your tag names separated by a space and hit enter

Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine.
Vaccine. 2012 Jan 05; 30(2):329-35.V

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 3.75 μg or 7.5 μg 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 3.75 μg and 7.5 μg 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 7.5 μg 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.

Authors+Show Affiliations

National University Hospital, 5 Lower Kent Ridge Road, Singapore.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22080174

Citation

Tambyah, Paul A., et al. "Safety and Immunogenicity of Two Different Doses of a Vero Cell-derived, Whole Virus Clade 2 H5N1 (A/Indonesia/05/2005) Influenza Vaccine." Vaccine, vol. 30, no. 2, 2012, pp. 329-35.
Tambyah PA, Wilder-Smith A, Pavlova BG, et al. Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine. Vaccine. 2012;30(2):329-35.
Tambyah, P. A., Wilder-Smith, A., Pavlova, B. G., Barrett, P. N., Oh, H. M., Hui, D. S., Yuen, K. Y., Fritsch, S., Aichinger, G., Loew-Baselli, A., van der Velden, M., Maritsch, F., Kistner, O., & Ehrlich, H. J. (2012). Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine. Vaccine, 30(2), 329-35. https://doi.org/10.1016/j.vaccine.2011.10.088
Tambyah PA, et al. Safety and Immunogenicity of Two Different Doses of a Vero Cell-derived, Whole Virus Clade 2 H5N1 (A/Indonesia/05/2005) Influenza Vaccine. Vaccine. 2012 Jan 5;30(2):329-35. PubMed PMID: 22080174.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine. AU - Tambyah,Paul A, AU - Wilder-Smith,Annelies, AU - Pavlova,Borislava G, AU - Barrett,P Noel, AU - Oh,Helen M L, AU - Hui,David S, AU - Yuen,Kwok-yung, AU - Fritsch,Sandor, AU - Aichinger,Gerald, AU - Loew-Baselli,Alexandra, AU - van der Velden,Maikel, AU - Maritsch,Friedrich, AU - Kistner,Otfried, AU - Ehrlich,Hartmut J, Y1 - 2011/11/12/ PY - 2010/11/26/received PY - 2011/09/26/revised PY - 2011/10/30/accepted PY - 2011/11/15/entrez PY - 2011/11/15/pubmed PY - 2012/3/22/medline SP - 329 EP - 35 JF - Vaccine JO - Vaccine VL - 30 IS - 2 N2 - 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 3.75 μg or 7.5 μg 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 3.75 μg and 7.5 μg 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 7.5 μg 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22080174/Safety_and_immunogenicity_of_two_different_doses_of_a_Vero_cell_derived_whole_virus_clade_2_H5N1__A/Indonesia/05/2005__influenza_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01738-5 DB - PRIME DP - Unbound Medicine ER -