Evidence map›Paper›PMID 23899469›Full record

ArticleHuman vaccines & immunotherapeutics2013

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

Jared Nelson, Stephen Rodriguez, Neil Finlayson, Jim Williams, Aaron Carnes

Open access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Jared NelsonVGXI, Inc.; The Woodlands, TX USA.
Stephen RodriguezVGXI, Inc.; The Woodlands, TX USA.
Neil FinlaysonCoridon Pty Ltd; Level 3, Translational Research Institute; Woolloongabba, QLD Australia.
Jim WilliamsNature Technology Corporation; Lincoln, NE USA.
Aaron CarnesNature Technology Corporation; Lincoln, NE USA.
Nature Technology Corporation (United States) · USOpexa Therapeutics (United States) · USTranslational Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two DNA vaccine plasmids encoding Herpes simplex virus type 2 (HSV-2) glycoprotein D, NTC8485-O2-gD2 and NTC8485-O2-UgD2tr, were produced at large scale under current good manufacturing practice (cGMP) for use in a Phase I human clinical trial. These DNA vaccines incorporate the regulatory agency compliant, minimal, antibiotic-free (AF) NTC8485 mammalian expression vector. Plasmid yields of>1 g/L were achieved using the HyperGRO™ fed-batch fermentation process, with successful scale up from 10 L process development scale to 320 L culture volume for cGMP production. The DNA vaccines were purified using a low residence time, high shear lysis process and AIRMIX(TM) technology, followed by chromatographic purification. This combination of optimized plasmid vector, high yield upstream production, and efficient downstream purification resulted in purified HSV-2 DNA vaccines with>99% total supercoiled plasmid, ≤ 0.2% RNA, ≤ 0.1% host cell genomic DNA, and ≤ 0.1 endotoxin units per mg.

Indexed as

Selection, GeneticAnti-Bacterial AgentsGenetic VectorsHerpes Simplex Virus VaccinesHerpesvirus 2, HumanHumansTechnology, PharmaceuticalVaccines, DNAAnti-Bacterial AgentsHerpes Simplex Virus VaccinesVaccines, DNAantibiotic-freeDNA vaccinedownstream processingEscherichia colifermentationHSV-2plasmid

Identifiers

PMID23899469
PMCPMC3906406
OpenAlexW1991540932

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.