Evidence map›Paper›PMID 28747172›Full record

ArticleBMC immunology2017

Characteristics of the specific humoral response in patients with advanced solid tumors after active immunotherapy with a VEGF vaccine, at different antigen doses and using two distinct adjuvants.

Javier Sánchez Ramírez, Yanelys Morera Díaz, Mónica Bequet-Romero, Francisco Hernández-Bernal, Katty-Hind Selman-Housein Bernal, Ana de la Torre Santos, Eduardo Rafael Santiesteban Álvarez, Yenima Martín Bauta, Cimara H Bermúdez Badell, Josué de la Torre Pupo and 3 more

Open access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in BMC immunology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

7 citing papers in PubMed, 17 citations in OpenAlex.

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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

13 authors at 4 institutions in 1 country.

Javier Sánchez RamírezDepartment of Pharmaceuticals, Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba. javier.sanchez@cigb.edu.cu.
Yanelys Morera DíazDepartment of Pharmaceuticals, Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba.
Mónica Bequet-RomeroDepartment of Pharmaceuticals, Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba.
Francisco Hernández-BernalDepartment of Clinical Research, CIGB, P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba.
Katty-Hind Selman-Housein BernalCenter of Medical and Surgical Research (CIMEQ), Playa, Siboney, Havana, 12100, Cuba.
Ana de la Torre Santos"Celestino Hernández Robau" Hospital, Santa Clara, 50100, Cuba.
Eduardo Rafael Santiesteban Álvarez"José Ramón López Tabranes" Hospital, Matanzas, 40100, Cuba.
Yenima Martín BautaDepartment of Clinical Research, CIGB, P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba.
Cimara H Bermúdez BadellDepartment of Clinical Research, CIGB, P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba.
Josué de la Torre PupoCenter of Medical and Surgical Research (CIMEQ), Playa, Siboney, Havana, 12100, Cuba.
Jorge V GavilondoDepartment of Pharmaceuticals, Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba.
CENTAURO-2 Team of Investigators
Marta Ayala AvilaDepartment of Pharmaceuticals, Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanacán, Havana, 10600, Cuba.
Centro de Ingeniería Genética y Biotecnología · CUCenter of Molecular Immunology (Cuba) · CUCuban Neuroscience Center · CUUniversity of Matanzas · CU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCIGB-247, a VSSP-adjuvanted VEGF-based vaccine, was evaluated in a phase I clinical trial in patients with advanced solid tumors (CENTAURO). Vaccination with the maximum dose of antigen showed an excellent safety profile, exhibited the highest immunogenicity and was the only one showing a reduction on platelet VEGF bioavailability. However, this antigen dose level did not achieve a complete seroconversion rate in vaccinated patients. These clinical results led us to the question whether a "reserve" of untapped immune response potential against VEGF could exist in cancer patients. To address this matter, CENTAURO-2 clinical trial was conducted where antigen and VSSP dose scale up were studied, and also incorporated the exploration of aluminum phosphate as adjuvant. These changes were made with the aim to increase immune response against VEGF.

resultsThe present study reports the characterization of the humoral response elicited by CIGB-247 from the combining of different antigen doses and adjuvants. Cancer patients were immunologically monitored for approximately 1 year. Vaccination with different CIGB-247 formulations exhibited a very positive safety profile. Cancer patients developed IgM, IgG or IgA antibodies specific to VEGF. Elicited polyclonal antibodies had the ability to block the interaction between VEGF and its receptors, VEGFR1 and VEGFR2. The highest humoral response was detected in patients immunized with 800 μg of antigen + 200 μg of VSSP. Off-protocol long-term vaccination did not produce negative changes in humoral response.

conclusionsVaccination with a human VEGF variant molecule as antigen in combination with VSSP or aluminum phosphate is immunogenic. The results of this study could contribute to the investigation of this vaccine therapy in an adequately powered efficacy trial.

trial registrationTrial registration number: RPCEC00000155. Cuban Public Clinical Trial Registry. Date of registration: June 06, 2013. Available from: http://registroclinico.sld.cu/ .

Indexed as

Immunotherapy, ActiveAdjuvants, ImmunologicAnimalsAntigens, NeoplasmCancer VaccinesChlorocebus aethiopsFemaleHumansImmunity, HumoralImmunoglobulin GMaleMiceMice, Inbred BALB CMice, Inbred C57BLNeoplasmsRabbitsAdjuvants, ImmunologicAntigens, NeoplasmCancer VaccinesImmunoglobulin GReceptors, Vascular Endothelial Growth FactorRecombinant ProteinsVascular Endothelial Growth Factor ACancer vaccineCIGB-247Clinical trialHumoral responseVEGF

Identifiers

PMID28747172
PMCPMC5530503
OpenAlexW2738096678

What OpenQuestion holds

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LicenceCC BY
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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.