Viruses 2012, 4(11), 3227-3244; doi:10.3390/v4113227
Article

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

Fraunhofer USA, Center for Molecular Biotechnology, Newark, DE 19711, USA
* Author to whom correspondence should be addressed.
Received: 25 October 2012; in revised form: 15 November 2012 / Accepted: 16 November 2012 / Published: 19 November 2012
(This article belongs to the Special Issue H5N1 Influenza Virus)
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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 µg) adjuvanted with Alhydrogel® (0.75 mg aluminum per dose) and the 90 µg 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 µg unadjuvanted group.
Keywords: influenza A; H5N1; recombinant vaccine; hemagglutinin; plant-produced vaccine

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MDPI and ACS Style

Chichester, J.A.; Jones, R.M.; Green, B.J.; Stow, M.; Miao, F.; Moonsammy, G.; Streatfield, S.J.; Yusibov, V. 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. Viruses 2012, 4, 3227-3244.

AMA Style

Chichester JA, Jones RM, Green BJ, Stow M, Miao F, Moonsammy G, Streatfield SJ, Yusibov V. 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. Viruses. 2012; 4(11):3227-3244.

Chicago/Turabian Style

Chichester, Jessica A.; Jones, R. M.; Green, Brian J.; Stow, Mark; Miao, Fudu; Moonsammy, George; Streatfield, Stephen J.; Yusibov, Vidadi. 2012. "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." Viruses 4, no. 11: 3227-3244.

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