Evidence map›Paper›PMID 34135375›Full record

ArticleScientific reports2021

Toxicity evaluation of ConvitVax breast cancer immunotherapy.

María A Duarte C, Jeismar M Carballo O, Yetsenia M De Gouveia, Angie García, Diana Ruiz, Teresa Gledhill, Eglys González-Marcano, Ana F Convit

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06023277 (A Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of ConvitVax in Metastatic Breast Cancer), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 55% 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.

NCT06023277 phase1 / phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of ConvitVax in Metastatic Breast Cancer

TypeinterventionalSponsorJacinto Convit World Organization Inc.Ran2024 to 2027Enrolled40ConditionsMetastatic Breast CancerArmsConvitVax
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

8 authors at 3 institutions in 1 country.

María A Duarte CUnidad Experimental de Inmunoterapia, Fundación Jacinto Convit, Caracas, Venezuela.
Jeismar M Carballo OJacinto Convit World Organization, Inc., Palo Alto, CA, USA.
Yetsenia M De GouveiaUnidad Experimental de Inmunoterapia, Fundación Jacinto Convit, Caracas, Venezuela.
Angie GarcíaFacultad de Medicina, Universidad Central de Venezuela, Caracas, Venezuela.
Diana RuizFacultad de Medicina, Universidad Central de Venezuela, Caracas, Venezuela.
Teresa GledhillServicio de Anatomía Patológica, Hospital José María Vargas, Caracas, Venezuela.
Eglys González-MarcanoJacinto Convit World Organization, Inc., Palo Alto, CA, USA.
Ana F ConvitUnidad Experimental de Inmunoterapia, Fundación Jacinto Convit, Caracas, Venezuela. ana.f.convit@jacintoconvit.org.
Central University of Venezuela · VEFundacion Venezolana de Investigaciones Sismologicas · VEHospital Vargas · VE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ConvitVax is a personalized vaccine for the treatment of breast cancer, composed of autologous tumor cells, bacillus Calmette-Guérin (BCG) and low concentrations of formalin. Previous pre-clinical studies show that this therapy induces a potent activation of the immune system and achieves an effective response against tumor cells, reducing the size of the tumor and decreasing the percentage of immunosuppressive cells. In the present study, we evaluate the toxicity of ConvitVax in healthy BALB/c mice to determine potential adverse effects related to the vaccine and each of its components. We used standard guidelines for pain, discomfort and distress recognition, continuously evaluated the site of the injection, and completed blood and urine clinical tests. Endpoint necropsy was performed, measuring the weight of organs and processing liver, kidney, thymus and lung for histological examination. Results show that the vaccine in its therapeutic dose, at 3 times its therapeutic concentration, and its individual components did not cause death or behavioral or biological changes, including any abnormalities in whole-body or organ weights, and tissue damage. These results support the safety of ConvitVax with minimal to no side-effects.

Indexed as

AnimalsBCG VaccineBreast NeoplasmsDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunotherapyMiceMice, Inbred BALB CBCG Vaccine

Identifiers

PMID34135375
PMCPMC8209199
OpenAlexW3168991017

What OpenQuestion holds

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LicenceCC BY
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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.