Evidence map›Paper›PMID 38543959›Full record

ArticleVaccines2024

Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine.

Rosa Bartolomeo, Fulvia Troise, Simona Allocca, Giulia Sdruscia, Rosa Vitale, Veronica Bignone, Anna Maria Petrone, Giuseppina Romano, Anna Morena D'Alise, Valentino Ruzza and 8 more

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2024. 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
0.6field-weighted citation impact, top 30% 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, 1 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
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 1 country.

Rosa BartolomeoNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Fulvia TroiseNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Simona AlloccaNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Giulia SdrusciaNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Rosa VitaleNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Veronica BignoneNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Anna Maria PetroneNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Giuseppina RomanoNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Anna Morena D'AliseNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.ORCID 0000-0002-0763-6269
Valentino RuzzaNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.ORCID 0000-0002-0728-4240
Irene GarziaNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Guido LeoniNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Rossella MeroneReiThera Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Francesca LanzaroReiThera Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Stefano CollocaReiThera Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Loredana SianiNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Elisa ScarselliNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.
Gabriella CotugnoNouscom Srl, Via di Castel Romano 100, 00128 Rome, Italy.ORCID 0009-0009-5880-0215
Nouscom (Italy) · ITRINA Consulting - Centro Sviluppo Materiali S.p.A. (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Quality control testing of vaccines, including potency assessment, is critical to ensure equivalence of clinical lots. We developed a potency assay to support the clinical advancement of Nous-209, a cancer vaccine based on heterologous prime/boost administration of two multivalent viral vector products: GAd-209 and MVA-209. These consist of a mix of four Adeno (Great Ape Adenovirus; GAd) and four Modified Vaccinia Ankara (MVA) vectors respectively, each containing a different transgene encoding a synthetic polypeptide composed of antigenic peptide fragments joined one after the other. The potency assay employs quantitative Reverse Transcription PCR (RT-Q-PCR) to quantitatively measure the transcripts from the four transgenes encoded by each product in in vitro infected cells, enabling simultaneous detection. Results showcase the assay's robustness and biological relevance, as it effectively detects potency loss in one component of the mixture comparably to in vivo immunogenicity testing. This report details the assay's setup and validation, offering valuable insights for the clinical development of similar genetic vaccines, particularly those encoding synthetic polypeptides.

Indexed as

cancer vaccinepotency assessmentquality control testingRT-Q-PCR potency assaysynthetic polypeptidesviral vectors

Identifiers

PMID38543959
PMCPMC10975996
OpenAlexW4392959063

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.