Tags

Type your tag names separated by a space and hit enter

Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults.
Clin Vaccine Immunol. 2015 Jan; 22(1):46-55.CV

Abstract

Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.).

Authors+Show Affiliations

Vaccine R&D, Baxter BioScience, Vienna, Austria gerald_aichinger@baxter.com.Vaccine R&D, Baxter BioScience, Vienna, Austria.Vaccine R&D, Baxter BioScience, Vienna, Austria.Global R&D, Baxter BioScience, Vienna, Austria.Global R&D, Baxter BioScience, Vienna, Austria.Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.DynPort Vaccine Company, Frederick, Maryland, USA.DynPort Vaccine Company, Frederick, Maryland, USA.Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

25355797

Citation

Aichinger, Gerald, et al. "Phase I/II Randomized Double-blind Study of the Safety and Immunogenicity of a Nonadjuvanted Vero Cell Culture-derived Whole-virus H9N2 Influenza Vaccine in Healthy Adults." Clinical and Vaccine Immunology : CVI, vol. 22, no. 1, 2015, pp. 46-55.
Aichinger G, Grohmann-Izay B, van der Velden MV, et al. Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults. Clin Vaccine Immunol. 2015;22(1):46-55.
Aichinger, G., Grohmann-Izay, B., van der Velden, M. V., Fritsch, S., Koska, M., Portsmouth, D., Hart, M. K., El-Amin, W., Kistner, O., & Barrett, P. N. (2015). Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults. Clinical and Vaccine Immunology : CVI, 22(1), 46-55. https://doi.org/10.1128/CVI.00275-14
Aichinger G, et al. Phase I/II Randomized Double-blind Study of the Safety and Immunogenicity of a Nonadjuvanted Vero Cell Culture-derived Whole-virus H9N2 Influenza Vaccine in Healthy Adults. Clin Vaccine Immunol. 2015;22(1):46-55. PubMed PMID: 25355797.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults. AU - Aichinger,Gerald, AU - Grohmann-Izay,Barbara, AU - van der Velden,Maikel V W, AU - Fritsch,Sandor, AU - Koska,Manuela, AU - Portsmouth,Daniel, AU - Hart,Mary Kate, AU - El-Amin,Wael, AU - Kistner,Otfried, AU - Barrett,P Noel, Y1 - 2014/10/29/ PY - 2014/10/31/entrez PY - 2014/10/31/pubmed PY - 2015/8/28/medline SP - 46 EP - 55 JF - Clinical and vaccine immunology : CVI JO - Clin. Vaccine Immunol. VL - 22 IS - 1 N2 - Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.). SN - 1556-679X UR - https://www.unboundmedicine.com/medline/citation/25355797/Phase_I/II_randomized_double_blind_study_of_the_safety_and_immunogenicity_of_a_nonadjuvanted_vero_cell_culture_derived_whole_virus_H9N2_influenza_vaccine_in_healthy_adults_ L2 - http://cvi.asm.org/cgi/pmidlookup?view=long&pmid=25355797 DB - PRIME DP - Unbound Medicine ER -