Evidence map›Paper›PMID 36298492›Full record

ArticleVaccines2022

Development and Qualification of an Antigen Integrity Assay for a

Kazutoyo Miura, Thao P Pham, Shwu-Maan Lee, Jordan Plieskatt, Ababacar Diouf, Issaka Sagara, Camila H Coelho, Patrick E Duffy, Yimin Wu, Carole A Long

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

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 81% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

10 authors at 3 institutions in 2 countries.

Kazutoyo MiuraLaboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA.ORCID 0000-0003-4455-2432
Thao P PhamLaboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA.
Shwu-Maan LeePATH's Malaria Vaccine Initiative (MVI), Washington, DC 20001, USA.
Jordan PlieskattPATH's Malaria Vaccine Initiative (MVI), Washington, DC 20001, USA.
Ababacar DioufLaboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA.
Issaka SagaraMalaria Research and Training Centre, University of Science, Techniques and Technologies, Bamako 1805, Mali.ORCID 0000-0002-8555-9983
Camila H CoelhoLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20814, USA.ORCID 0000-0002-7885-9996
Patrick E DuffyLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20814, USA.ORCID 0000-0002-4483-5005
Yimin WuPATH's Malaria Vaccine Initiative (MVI), Washington, DC 20001, USA.
Carole A LongLaboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA.
National Institutes of Health · USU.S. President's Malaria Initiative · USUniversité des Sciences, des Techniques et des Technologies de Bamako · ML

Funding

Global Health Innovative Technology Fund G2019-205National Institute of Allergy and Infectious Diseases intramural programPATH na
6 · The paper itself

Abstract

During development of a subunit vaccine, monitoring integrity of the recombinant protein for process development and quality control is critical. Pfs230 is a leading malaria transmission blocking vaccine candidate and the first to reach a Phase 2 clinical trial. The Pfs230 protein is expressed on the surface of gametes, and plays an important role in male fertility. While the potency of Pfs230 protein can be determined by a standard membrane-feeding assay (SMFA) using antibodies from immunized subjects, the precision of a general in vivo potency study is known to be poor and is also time-consuming. Therefore, using a well-characterized Pfs230 recombinant protein and two human anti-Pfs230 monoclonal antibodies (mAbs), which have functional activity judged by SMFA, a sandwich ELISA-based in vitro potency assay, called the Antigen Integrity Assay (AIA), was developed. Multiple validation parameters of AIA were evaluated to qualify the assay following International Conference on Harmonization (ICH) Q2(R1) guidelines. The AIA is a high throughput assay and demonstrated excellent precision (3.2 and 5.4% coefficients of variance for intra- and inter-assay variability, respectively) and high sensitivity (>12% impurity in a sample can be detected). General methodologies and the approach to assay validation described herein are amenable to any subunit vaccine as long as more than two functional, non-competing mAbs are available. Thus, this study supports future subunit vaccine development.

Indexed as

assay qualificationintegritymalariaPfs230potencysubunit vaccinetransmission-blocking vaccine

Identifiers

PMID36298492
PMCPMC9607959
OpenAlexW4298003424

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.