The baculovirus expression vector system: a modern technology for the future of influenza vaccine manufacturing

Figures & data

Figure 1. Schematic representation of production process of RIV.

Table 1. Overview of clinical studies supporting RIV4 licensure. rHA: recombinant hemagglutinin.

Study	Population	Purpose of study	Active Comparator/ Control	Location	Seasons	Number of subjects	References
Phase III
PSC12 NCT02285998	Adults aged ≥ 50 years, medically stable	Randomized controlled trial to establish that RIV4 is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (QIVe, Fluarix® Quadrivalent, GSK) in protecting against laboratory- confirmed clinical influenza disease	One injection of RIV4 containing 45 μg of rHA per strain or; QIVe containing 15 μg of HA per strain	US	2014–2015	RIV4: 4328 QIVe: 4344	(Dunkle et al., 2017) [75]
PSC16 NCT02290509	Healthy adults aged 18 to 49 years	Randomized controlled trial to demonstrate the safety and non-inferior immunogenicity of all 4 vaccine antigens of RIV4 vs. a licensed comparator (QIVe, Fluarix® Quadrivalent, GSK)	One injection of RIV4 containing 45 μg of HA per strain or; QIVe containing 15 μg of HA per strain	US	2014–2015	RIV4:1011 QIVe: 339	(Dunkle et al., 2017) [81]
Phase II
PSC08 NCT01959945	Healthy children and adolescents age 6–17 years	Exploratory study to assess the safety, reactogenicity, and immunogenicity of RIV4 compared with QIVe (Fluarix® Quadrivalent, GSK) in the pediatric population 6–17 years of age	One injection of RIV4 containing 45 μg of HA per strain or QIVe containing 15 μg of HA per strain	US	2013–2014	RIV4 (9–17 years of age): 80 RIV4 (6–8 years of age): 28 QIVe (9–17 years of age): 78 QIVe (6–8 years of age): 31	(Dunkle et al., 2018) [80]

Cox MM, Patriarca PA, Treanor J. FluBlok, a recombinant hemagglutinin influenza vaccine. Influenza Other Respir Viruses. 2008;2(6):211–219.

 PubMed Web of Science ®Google Scholar

Treanor JJ, El Sahly H, King J, et al. Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok(R)) against influenza in healthy adults: a randomized, placebo-controlled trial. Vaccine. 2011;29(44):7733–7739.

 PubMed Web of Science ®Google Scholar

Baxter R, Patriarca PA, Ensor K, et al. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok(R) trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine. 2011;29(12):2272–2278.

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