Evidence map›Paper›PMID 37507392›Full record

Trial reportNature communications2023

Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in healthy adults.

Karina A Pasquevich, Lorena M Coria, Ana Ceballos, Bianca Mazzitelli, Juan Manuel Rodriguez, Agostina Demaría, Celeste Pueblas Castro, Laura Bruno, Lucas Saposnik, Melina Salvatori and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05656508 (Phase 1 Study to Evaluate Safety, Tolerability and Immunogenicity of a New Recombinant Protein-based Vaccine), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.9field-weighted citation impact, top 8% 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.

NCT05656508 phase1completednot on this map

Phase 1 Study to Evaluate Safety, Tolerability and Immunogenicity of a New Recombinant Protein-based Vaccine (ARVAC CG) Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), in a Population of Healthy Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.

TypeinterventionalSponsorLaboratorio Pablo Cassara S.R.L.Ran2022 to 2023Enrolled80ConditionsCOVID-19 VaccineArmsARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
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

25 authors at 4 institutions in 3 countries.

Karina A PasquevichInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina. kpasquevich@iib.unsam.edu.ar.ORCID 0000-0003-4448-0977
Lorena M CoriaInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina.ORCID 0000-0001-5359-8382
Ana CeballosInstituto de Investigaciones Biomédicas en Retrovirus y SIDA, INBIRS-CONICET, Facultad de Medicina UBA, Buenos Aires, Argentina.
Bianca MazzitelliInstituto de Investigaciones Biomédicas en Retrovirus y SIDA, INBIRS-CONICET, Facultad de Medicina UBA, Buenos Aires, Argentina.
Juan Manuel RodriguezFundación Pablo Cassará - Unidad de I + D de Biofármacos, Saladillo 2452 C1440FFX, Ciudad Autónoma de Buenos Aires, Argentina.
Agostina DemaríaInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina.
Celeste Pueblas CastroInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina.
Laura BrunoInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina.
Lucas SaposnikInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina.
Melina SalvatoriInstituto de Investigaciones Biomédicas en Retrovirus y SIDA, INBIRS-CONICET, Facultad de Medicina UBA, Buenos Aires, Argentina.
Augusto VareseInstituto de Investigaciones Biomédicas en Retrovirus y SIDA, INBIRS-CONICET, Facultad de Medicina UBA, Buenos Aires, Argentina.
Soledad GonzálezMinisterio de Salud de la Provincia de Buenos Aires, Buenos Aires, Argentina.
Veronica V González MartínezMinisterio de Salud de la Provincia de Buenos Aires, Buenos Aires, Argentina.ORCID 0000-0001-5231-1773
Jorge GeffnerInstituto de Investigaciones Biomédicas en Retrovirus y SIDA, INBIRS-CONICET, Facultad de Medicina UBA, Buenos Aires, Argentina.
Diego ÁlvarezInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina.
Laboratorio Pablo Cassará R&D and CMC for ARVAC CG consortium
Ethel FelederFP CLINICAL PHARMA, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Karina HalabeFP CLINICAL PHARMA, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Pablo E Perez LeraFP CLINICAL PHARMA, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Federico Montes de OcaLaboratorio Pablo Cassará - Unidad de I + D de Biofármacos, Saladillo 2452 C1440FFX, Ciudad Autónoma de Buenos Aires, Argentina.
Julio C VegaLaboratorio Pablo Cassará - Unidad de I + D de Biofármacos, Saladillo 2452 C1440FFX, Ciudad Autónoma de Buenos Aires, Argentina.
Mónica LombardoNobeltri, Ciudad Autónoma de Buenos Aires, Argentina.
Gustavo A YerinoFP CLINICAL PHARMA, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Juan FlóLaboratorio Pablo Cassará - Unidad de I + D de Biofármacos, Saladillo 2452 C1440FFX, Ciudad Autónoma de Buenos Aires, Argentina.ORCID 0000-0002-0051-7435
Juliana CassataroInstituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina. jucassataro@iib.unsam.edu.ar.ORCID 0000-0002-7122-869X
Consejo Nacional de Investigaciones Científicas y Técnicas · ARUniversidad Autónoma de la Ciudad de México · MXMinisterio de Salud - Provincia de Buenos Aires · ARNational University of General San Martín · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A Gamma Variant RBD-based aluminum hydroxide adjuvanted vaccine called ARVAC CG was selected for a first in human clinical trial. Healthy male and female participants (18-55 years old) with a complete COVID-19-primary vaccine scheme were assigned to receive two intramuscular doses of either a low-dose or a high-dose of ARVAC CG. The primary endpoint was safety. The secondary objective was humoral immunogenicity. Cellular immune responses were studied as an exploratory objective. The trial was prospectively registered in PRIISA.BA (Registration Code 6564) and ANMAT and retrospectively registered in ClinicalTrials.gov (NCT05656508). Samples from participants of a surveillance strategy implemented by the Ministry of Health of the Province of Buenos Aires that were boosted with BNT162b2 were also analyzed to compare with the booster effect of ARVAC CG. ARVAC CG exhibits a satisfactory safety profile, a robust and broad booster response of neutralizing antibodies against the Ancestral strain of SARS-CoV-2 and the Gamma, Delta, Omicron BA.1 and Omicron BA.5 variants of concern and a booster effect on T cell immunity in individuals previously immunized with different COVID-19 vaccine platforms.

Indexed as

COVID-19VaccinesAdjuvants, ImmunologicAdolescentAdultAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesFemaleHumansMaleMiddle AgedSARS-CoV-2Young AdultAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesVaccines

Identifiers

PMID37507392
PMCPMC10382514
OpenAlexW4385342862

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.