tetano
Editor, Senior Moderator
Viruses. 2012 Nov 19;4(11):3227-44. doi: 10.3390/v4113227.
Safety and Immunogenicity of a Plant-Produced Recombinant Hemagglutinin-Based Influenza Vaccine (HAI-05) Derived from A/Indonesia/05/2005 (H5N1) Influenza Virus: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy Adults.
Chichester JA, Jones RM, Green BJ, Stow M, Miao F, Moonsammy G, Streatfield SJ, Yusibov V.
Source
Fraunhofer USA, Center for Molecular Biotechnology, Newark, DE 19711, USA. vyusibov@fraunhofer-cmb.org.
Abstract
Recently, we have reported [1,2] on a subunit influenza vaccine candidate based on the recombinant hemagglutinin protein from the A/Indonesia/05/2005 (H5N1) strain of influenza virus, produced it using 'launch vector'-based transient expression technology in Nicotiana benthamiana, and demonstrated its immunogenicity in pre-clinical studies. Here, we present the results of a first-in-human, Phase 1 randomized, double-blind, placebo-controlled study designed to investigate safety, reactogenicity and immunogenicity of three escalating dose levels of this vaccine, HAI-05, (15, 45 and 90 ?g) adjuvanted with Alhydrogel? (0.75 mg aluminum per dose) and the 90 ?g dose level without Alhydrogel?. Vaccine was administered intramuscularly in two injections three weeks apart to healthy adults of 18-49 years of age. At all dose levels the vaccine was generally safe and well tolerated, with no reported serious adverse events or dose-limiting toxicities. Mild local and systemic reactions were observed in all vaccine dose groups and the placebo group and their occurrence was not dose related. The incidence rates were higher in the groups receiving vaccine with Alhydrogel?. The immune response elicited by the HAI-05 vaccine was variable with respect to both hemagglutination-inhibition and virus microneutralization antibody titers, with the highest responses observed in the 90 ?g unadjuvanted group.
PMID:
23202523
[PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/23202523
Safety and Immunogenicity of a Plant-Produced Recombinant Hemagglutinin-Based Influenza Vaccine (HAI-05) Derived from A/Indonesia/05/2005 (H5N1) Influenza Virus: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy Adults.
Chichester JA, Jones RM, Green BJ, Stow M, Miao F, Moonsammy G, Streatfield SJ, Yusibov V.
Source
Fraunhofer USA, Center for Molecular Biotechnology, Newark, DE 19711, USA. vyusibov@fraunhofer-cmb.org.
Abstract
Recently, we have reported [1,2] on a subunit influenza vaccine candidate based on the recombinant hemagglutinin protein from the A/Indonesia/05/2005 (H5N1) strain of influenza virus, produced it using 'launch vector'-based transient expression technology in Nicotiana benthamiana, and demonstrated its immunogenicity in pre-clinical studies. Here, we present the results of a first-in-human, Phase 1 randomized, double-blind, placebo-controlled study designed to investigate safety, reactogenicity and immunogenicity of three escalating dose levels of this vaccine, HAI-05, (15, 45 and 90 ?g) adjuvanted with Alhydrogel? (0.75 mg aluminum per dose) and the 90 ?g dose level without Alhydrogel?. Vaccine was administered intramuscularly in two injections three weeks apart to healthy adults of 18-49 years of age. At all dose levels the vaccine was generally safe and well tolerated, with no reported serious adverse events or dose-limiting toxicities. Mild local and systemic reactions were observed in all vaccine dose groups and the placebo group and their occurrence was not dose related. The incidence rates were higher in the groups receiving vaccine with Alhydrogel?. The immune response elicited by the HAI-05 vaccine was variable with respect to both hemagglutination-inhibition and virus microneutralization antibody titers, with the highest responses observed in the 90 ?g unadjuvanted group.
PMID:
23202523
[PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/23202523
