Evidence map›Paper›PMID 34169270›Full record

ArticleVaccine: X2021

Potency testing for a recombinant protein vaccine early in clinical development: Lessons from the

Guangzhao Li, Lara Hoeweler, Brian Keegan, Jin Peng, Larissa Scholte, Peter Hotez, Maria Elena Bottazzi, David Diemert, Jeffrey Bethony

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine: X, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Trial
  2. Therapeutic challenges of schistosomiasis: mechanisms of action and current limitations.Journal of parasitic diseases : official organ of the Indian Society for Parasitology · 2025
    Review
  3. Review
  4. Human Schistosomiasis Vaccines as Next Generation Control Tools.Tropical medicine and infectious disease · 2023
    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

9 authors.

Guangzhao LiDepartment of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington DC, USA.
Lara HoewelerDepartment of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington DC, USA.
Brian KeeganTexas Children's Hospital Center for Vaccine Development, USA.
Jin PengDepartment of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington DC, USA.
Larissa ScholteDepartment of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington DC, USA.
Peter HotezTexas Children's Hospital Center for Vaccine Development, USA.
Maria Elena BottazziTexas Children's Hospital Center for Vaccine Development, USA.
David DiemertDepartment of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington DC, USA.
Jeffrey BethonyDepartment of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAs a primary stability-indicating parameter, potency should be strategically evaluated during each phase of vaccine development. Herein, we present potency testing during the early clinical development of the

methodsPotency data were analyzed using the compliance approach to determine if two clinical lots of

resultsDespite significant variability in the immune assay, both clinical lots of

conclusionWhile a compliance approach can monitor the long-term stability of

Indexed as

Bootstrap modelingCompliance approachControl chartingLeast-squares regressionPotencyVaccine

Identifiers

PMID34169270
PMCPMC8209742

What OpenQuestion holds

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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.