ArticleMolecular therapy. Methods & clinical development2025
Method validation and assessment of the biodistribution and shedding for adenovirus vector-based vaccine using qPCR and dPCR.
Article in Molecular therapy. Methods & clinical development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- Impact of Extraction Recovery and Matrix Effect on qPCR-based Biodistribution Analysis in Gene Therapy: Strategies for Mitigation.The AAPS journal · 2026Article
- Development and validation of a crystal digital PCR assay for duck Tembusu virus detection and vaccine monitoring.Poultry science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Assessment of the biodistribution and shedding is required for the development of viral vector-based vaccines. Vector copy number is commonly quantified using digital PCR (dPCR) or quantitative PCR (qPCR). However, the regulatory guidelines for bioanalytical PCR assays have not been released at present. To consider the future setting of acceptance criteria for method validation in a guideline, we aimed to develop and validate a method for quantifying a model adenoviral (Ad) vector vaccine (Ad-hCovHKU1S-2A-GFP) using dPCR and qPCR in biological matrices and assessed its biodistribution in mice. Primers and probes were designed for the region between the sequences of the Ad and HKU1S. Method development and validation were performed using dPCR and qPCR with 1 μg of mouse genomic DNA (gDNA)/reaction. The validation parameters and their acceptance criteria were pre-defined as possible values referred from the literature. Lower limits of quantitation were set as 12 copies and 48 copies/reaction for dPCR and qPCR, respectively. Both dPCR and qPCR met the pre-defined acceptance criteria for intra- and inter-run accuracy and precision. Cross-validation showed similar quantitative results using both dPCR and qPCR. The pre-defined acceptance criteria on dPCR and qPCR may be applicable to the biodistribution and shedding of viral vector-based vaccines.
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.