Evidence map›Paper›PMID 35822551›Full record

ArticleBiotechnology and bioengineering2022

Production of a high purity, C-tagged hepatitis B surface antigen fusion protein VLP vaccine for malaria expressed in Pichia pastoris under cGMP conditions.

Ekta Mukhopadhyay, Florian Brod, Philip Angell-Manning, Nicola Green, Richard D Tarrant, Frank J Detmers, Emma J Bolam, Ioana N Baleanu, Mark Hobson, Gary Whale and 8 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Biotechnology and bioengineering, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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

18 authors at 2 institutions in 2 countries.

Ekta MukhopadhyayClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-6045-2522
Florian BrodThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Philip Angell-ManningClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Nicola GreenClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Richard D TarrantClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Frank J DetmersThermo Fisher Scientific, Leiden, The Netherlands.
Emma J BolamClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Ioana N BaleanuClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Mark HobsonClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Gary WhaleClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Susan J MorrisThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Rebecca AshfieldThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Sarah C GilbertThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Jing JinThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Simon J DraperThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Sarah P MoyleClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Eleanor L BerrieClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Adrian V S HillThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
University of Oxford · GBThermo Fisher Scientific (Netherlands) · NL

Funding

Medical Research Council MR/J008680/1Wellcome Trust
6 · The paper itself

Abstract

Virus-like particles (VLPs) induce strong humoral and cellular responses and have formed the basis of some currently licensed vaccines. Here, we present the method used for the production of R21, a VLP-based anti-sporozoite malaria vaccine, under current Clinical Good Manufacturing Practice regulations (cGMP). Previous preclinical studies in BALB/c mice showed that R21 produced almost complete protection against sporozoite challenge with transgenic Plasmodium berghei parasites. Here, we have modified the preclinical production process to enable the production of sufficient quantities of highly pure, clinical-grade material for use in human clinical trials. The R21 construct was re-engineered to include a C-tag to allow affinity-based separation from the major contaminant alcohol oxidase 1 (AOX 1, ~74 kDa). To our knowledge, this is the first use of C-tag technology to purify a VLP vaccine candidate for use in human clinical trials. The R21 vaccine has shown high-level efficacy in an African Phase IIb trial, and multiple clinical trials are underway to assess the safety and efficacy of the vaccine. Our findings support the future use of C-tag platform technologies to enable cGMP-compliant biomanufacturing of high purity yeast-expressed VLP-based vaccines for early phase clinical trials when clinical grade material is required in smaller quantities in a quick time frame.

Indexed as

MalariaMalaria VaccinesSaccharomycetalesVaccines, Virus-Like ParticleViral VaccinesAnimalsHepatitis B Surface AntigensHumansMiceMice, Inbred BALB CPichiaHepatitis B Surface AntigensMalaria VaccinesVaccines, Virus-Like ParticleViral VaccinescGMPmalariavaccine

Identifiers

PMID35822551
PMCPMC9546177
OpenAlexW4285087490

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.