Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults

Cox, Manon; Izikson, Ruvim; Post, Penny; Dunkle, Lisa M.

doi:10.1177/2051013615595595

Cited by 102 publications

(85 citation statements)

References 39 publications

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“…Instead, it demands excellent viral clearance measures, such as those that have been developed by Protein Sciences Corporation to ensure the safety of their products (Post, 2010). Accordingly, Protein Sciences has administered Flublok® to nearly 2500 adults in five randomized, placebo- or active-controlled human clinical trials and successfully documented its safety (Cox et al, 2015). Like other experts in the field, we are well aware of this track record and, therefore, it should be obvious our analysis of the recent publication on Sf-rhabdovirus contamination of Sf9 L5814 cells is intended to provide a scientific assessment of the results and conclusions presented therein (Hashimoto et al, 2017), not, in any way, to criticize any product commercialized by Protein Sciences Corporation.…”

Section: Summary and Perspectivesmentioning

confidence: 99%

Infectivity of Sf-rhabdovirus variants in insect and mammalian cell lines

Maghodia¹,

Jarvis

2017

Virology

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Sf-rhabdovirus was only recently identified as an adventitious agent of Spodoptera frugiperda (Sf) cell lines used as hosts for baculovirus vectors. As such, we still know little about its genetic variation, infectivity, and the potential impact of variation on the Sf-rhabdovirus-host interaction. Here, we characterized Sf-rhabdoviruses from two widely used Sf cell lines to confirm and extend information on Sf-rhabdovirus variation. We then used our novel Sf-rhabdovirus-negative (Sf-RVN) Sf cell line to assess the infectivity of variants with and without a 320 bp X/L deletion and found both established productive persistent infections in Sf-RVN cells. We also assessed their infectivity using heterologous insect and mammalian cell lines and found neither established productive persistent infections in these cells. These results are the first to directly demonstrate Sf-rhabdoviruses are infectious for Sf cells, irrespective of the X/L deletion. They also confirm and extend previous results indicating Sf-rhabdoviruses have a narrow host range.

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Section: Summary and Perspectivesmentioning

confidence: 99%

Infectivity of Sf-rhabdovirus variants in insect and mammalian cell lines

Maghodia¹,

Jarvis

2017

Virology

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“…There are three types of seasonal influenza vaccines that are currently licensed for use in humans in the U.S.: 1) inactivated; 2) live attenuated; and 3) recombinant HA influenza vaccines[9–13]. Inactivated influenza vaccines and recombinant HA vaccines are administered intramuscularly (i.m.…”

Section: Current Influenza Vaccines and Their Limitationsmentioning

confidence: 99%

Vaccine approaches conferring cross-protection against influenza viruses

Vemula

Sayedahmed

Sambhara

et al. 2017

Expert Review of Vaccines

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Introduction Annual vaccination is one of the most efficient and cost-effective strategies to prevent and control influenza epidemics. Most of currently available influenza vaccines are strong inducer of antibody responses against viral surface proteins, hemagglutinin (HA) and neuraminidase (NA), but are poor inducers of cell-mediated immune responses against conserved internal proteins. Moreover, due to the high variability of viral surface proteins because of antigenic drift or antigenic shift, many of the currently licensed vaccines confer little or no protection against drift or shift variants. Areas covered Next generation influenza vaccines that can induce humoral immune responses to receptor-binding epitopes as well as broadly neutralizing conserved epitopes, and cell-mediated immune responses against highly conserved internal proteins would be effective against variant viruses as well as a novel pandemic influenza until circulating strain-specific vaccines become available. Here we discuss vaccine approaches that have potential to provide broad spectrum protection against influenza viruses. Expert opinion Based on current progress in defining cross-protective influenza immunity, it seems that the development of a universal influenza vaccine is feasible. It would revolutionize the strategy for influenza pandemic preparedness, and significantly impact the shelf-life and protection efficacy of seasonal influenza vaccines.

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“…However, in recent years alternative vaccines have entered the US market, most notably a seasonal influenza vaccine made from recombinant hemagglutinin protein produced in insect cells (Flublok Ò , Protein Sciences Corporation). 84 Approved by the FDA for use in all adults, Flublok is classed as pregnancy category B, which means that studies in animals have shown no risk. While minimal data is currently available on Flublok use in pregnant women, such data should accrue with time now it is part of the seasonal vaccine market.…”

Section: Future Prospectsmentioning

confidence: 99%