Antibiotic-free production of a herpes simplex virus 2 DNA vaccine in a high yield cGMP process

Nelson, Jared L.; Rodriguez, Stephen A.; Finlayson, Neil; Williams, Jim; Carnes, Aaron E.

doi:10.4161/hv.25048

Cited by 17 publications

(13 citation statements)

References 11 publications

(14 reference statements)

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“…Unlike minicircles, both MIP and Nanoplasmid TM RNA-OUT selection vectors can be efficiently manufactured in gram/liter yields without antibiotic selection. 140 As expected, both vector platforms alleviate gene silencing in quiescent tissues similarly to minicircle vectors. 141,142 However, unexpectedly both MIP and Nanoplasmid TM vectors dramatically improve overall gene expression up to 10-fold compared with plasmid and minicircle vectors in quiescent (liver) and non-quiescent tissues.…”

Section: Improvements In Dna Plasmid Designsupporting

confidence: 63%

Advancements in DNA vaccine vectors, non-mechanical delivery methods, and molecular adjuvants to increase immunogenicity

Suschak

Williams

Schmaljohn

2017

Human Vaccines & Immunotherapeutics

195

181

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A major advantage of DNA vaccination is the ability to induce both humoral and cellular immune responses. DNA vaccines are currently used in veterinary medicine, but have not achieved widespread acceptance for use in humans due to their low immunogenicity in early clinical studies. However, recent clinical data have re-established the value of DNA vaccines, particularly in priming high-level antigen-specific antibody responses. Several approaches have been investigated for improving DNA vaccine efficacy, including advancements in DNA vaccine vector design, the inclusion of genetically engineered cytokine adjuvants, and novel non-mechanical delivery methods. These strategies have shown promise, resulting in augmented adaptive immune responses in not only mice, but also in large animal models. Here, we review advancements in each of these areas that show promise for increasing the immunogenicity of DNA vaccines.

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Section: Improvements In Dna Plasmid Designsupporting

confidence: 63%

Advancements in DNA vaccine vectors, non-mechanical delivery methods, and molecular adjuvants to increase immunogenicity

Suschak

Williams

Schmaljohn

2017

Human Vaccines & Immunotherapeutics

195

181

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“…The COR-1 vaccine was manufactured under Good Manufacturing Practice (GMP) conditions by VGXI Inc. (Texas, United States) under license from Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd), as previously described 25 . The vaccine was supplied frozen at a concentration of 2.5 mg/mL to the investigation site.…”

Section: Methodsmentioning

confidence: 99%

An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1

Dutton

Woo

Chandra

et al. 2016

Human Vaccines & Immunotherapeutics

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This paper describes a single site, open-label Phase I clinical trial evaluating the safety, tolerability and immunogenicity in healthy volunteers of a herpes simplex polynucleotide vaccine that has previously been shown to enhance immunogenicity and protect against lethal herpes simplex virus type 2 (HSV-2) challenge in mice. Five escalating doses of the vaccine, COR-1, were given by intradermal injection to HSV-1 and 2 seronegative healthy individuals. COR-1 was found to be safe and well-tolerated; the only vaccine-related adverse events were mild. While vaccine-induced antibody responses were not detectable, cell-mediated immune responses to HSV-specific peptide groups were identified in 19 of the 20 subjects who completed the study, and local inflammation at the immunisation site was observed. This study indicates COR-1 has potential to be used as a therapeutic vaccine for HSV-2 infection.

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“…The exponential feeding and temperature shifting strategies used with the pVAX1GFP fermentations were similar to those used in a fed-batch process using proprietary media containing glycerol and yeast extract that has achieved pDNA yields of >2000 mg/L in DH5␣ Carnes et al, 2011), and which has been used for cGMP production of clinical grade pDNA for human clinical trials (Nelson et al, 2013). This same high yield process was used to evaluate production of plasmid NTC7482-41H-HA in strains MG1655 endA recA and GALG20 using glycerol as the carbon source.…”

Section: High Cell Density Fed-batch Culturesmentioning

confidence: 99%

Plasmid DNA production with Escherichia coli GALG20, a pgi-gene knockout strain: Fermentation strategies and impact on downstream processing

Gonçalves

Prather

Monteiro

et al. 2014

Journal of Biotechnology

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Antibiotic-free production of a herpes simplex virus 2 DNA vaccine in a high yield cGMP process

Cited by 17 publications

References 11 publications

Advancements in DNA vaccine vectors, non-mechanical delivery methods, and molecular adjuvants to increase immunogenicity

Advancements in DNA vaccine vectors, non-mechanical delivery methods, and molecular adjuvants to increase immunogenicity

An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1

Plasmid DNA production with Escherichia coli GALG20, a pgi-gene knockout strain: Fermentation strategies and impact on downstream processing

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