ArticleIranian biomedical journal2024
Development of a Monocyte Activation Test for Evaluating Recombinant Hepatitis B Vaccine: A Novel Approach for Pyrogen Assessment.
Article in Iranian biomedical journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Injectable products, particularly human vaccines, must be free from fever-inducing agents and thoroughly tested for pyrogens as part of a quality control. Consequently, manufacturing facilities are required to conduct ppropriate pyrogen tests per pharmacopoeial standards. This study aimed to evaluate the reliability of the monocyte activation test (MAT) in quantifying pyrogenic content in the recombinant hepatitis B vaccine. Methods: We assessed pyrogen activity in the active pharmaceutical ingredient (API), formulated vaccine, and aluminum hydroxide by comparing the limulus amebocyte lysate (LAL), rabbit pyrogen test (RPT), and MAT, measuring activity in relative pyrogen unit (RPU) as per the European Pharmacopoeia. Monocytes from healthy donors were isolated and identified via flow cytometry to measure the CD14+ marker frequency. Results: The study found that the pyrogenic concentration of lipoteichoic acid (LTA) in the MAT was 50,000 ng/mL (5.19 EEU/mL). In contrast, the same concentration in the rabbit pyrogen test (RPT) was deemed non-pyrogenic based on rectal temperature assessments. The MAT showed sensitivity to the API and adjuvant, with a detection limit of 2.5 EU/mL for IL-6, outperforming the RPT, which had a detection limit of 5 EU/mL. Conclusion: A strong IL-6 response to both lipopolysaccharide (LPS) and LTA stimulation was observed, indicating that IL-6 could serve as a valuable marker for pyrogen testing. The MAT appears to be an effective alternative to the RPT for assessing pyrogenicity, demonstrating commendable consistency and accuracy across various testing systems allowed by the Ph. Eur. General MAT Chapter, especially given the RPT's limitations in controlling pyrogenicity in injectable products.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.