Evidence map›Paper›PMID 40577471›Full record

Trial reportScience advances2025

Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine.

Constantino López-Macías, Martha Torres, Brenda Armenta-Copca, Niels H Wacher, Arturo Galindo-Fraga, Laura Castro-Castrezana, Andrea Alicia Colli-Domínguez, Edgar Cervantes-Trujano, Isabel Erika Rucker-Joerg, Fernando Lozano-Patiño and 29 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIEquivalence Trial
In one paragraph

Trial report in Science advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

39 authors.

Constantino López-MacíasUnidad de Investigación Médica en Inmunoquímica, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México (CDMX), México.ORCID 0000-0003-0530-492X
Martha TorresLaboratorio de Inmunobiología de la Tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER) "Ismael Cosío Villegas," CDMX, México.ORCID 0000-0003-3217-9407
Brenda Armenta-CopcaiLS Clinical Research S.C., CDMX, México.ORCID 0009-0003-8894-2413
Niels H WacherUnidad de Investigación Médica en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, CDMX, México.ORCID 0000-0002-7717-6704
Arturo Galindo-FragaInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), CDMX, México.ORCID 0000-0002-2818-1160
Laura Castro-CastrezanaCAIMED Investigación en Salud S.A. de C.V., CDMX, México.ORCID 0009-0006-1461-5593
Andrea Alicia Colli-DomínguezOaxaca Site Management Organization (OSMO) S.C., Oaxaca, México.ORCID 0009-0002-0212-136X
Edgar Cervantes-TrujanoCentro de Investigación Clínica Acelerada (CICA) S.C., CDMX, México.ORCID 0000-0002-5321-5748
Isabel Erika Rucker-JoergClinical Research Institute (CRI) S.C., Edo. de México, Tlalnepantla, México.
Fernando Lozano-PatiñoCentro de Investigación Clínica Chapultepec, CDMX, México.ORCID 0000-0001-7998-1339
Juan José Rivera-AlcocerUnidad de Atención Médica e Investigación en Salud (UNAMIS), Mérida, Yucatán, México.ORCID 0009-0003-9297-9139
Abraham Simón-CamposKöhler & Milstein Research (K&M) Facultad de Medicina, Universidad Autónoma de Yucatán, Mérida, Yucatán, México.ORCID 0000-0001-9630-7792
Efrén Alberto Sánchez-CamposCentro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán (CEMDEICY) S.C., Mérida, Yucatán, México.ORCID 0000-0002-9284-2541
Rafael Aguirre-RiveroCentro de Investigación Clínica del Pacifico (CICPA), Acapulco, Guerrero, México.ORCID 0009-0001-7834-743X
Alejandro José Muñiz-CarvajalRed OSMO, Centro de Investigación y Avances Médicos Especializados (CIAME), Cancún, Quintana Roo, México.ORCID 0000-0002-1522-4141
Luis Del Carpio-OrantesInstituto Veracruzano de Investigación Clínica (IVIC) S.C., Veracruz, México.ORCID 0000-0003-2436-5744
Francisco Márquez-DíazHospital de Cardiología de Aguascalientes, Aguascalientes, México.ORCID 0009-0008-6419-2140
Tania Rivera-HernándezUnidad de Investigación Médica en Inmunoquímica, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México (CDMX), México.
Alejandro Torres-FloresUnidad de Investigación Médica en Inmunoquímica, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México (CDMX), México.ORCID 0000-0003-3705-6692
Luis Ramírez-MartínezLaboratorio Avi-Mex S.A. de C.V., CDMX, México.ORCID 0000-0002-9162-5721
Georgina Paz-De la RosaLaboratorio Avi-Mex S.A. de C.V., CDMX, México.ORCID 0000-0002-0491-9271
Oscar Rojas-MartínezLaboratorio Avi-Mex S.A. de C.V., CDMX, México.ORCID 0009-0006-5334-8803
Alejandro Suárez-MartínezLaboratorio Avi-Mex S.A. de C.V., CDMX, México.ORCID 0009-0002-0723-8145
Gustavo Peralta-SánchezLaboratorio Avi-Mex S.A. de C.V., CDMX, México.ORCID 0000-0003-1174-8455
Claudia CarranzaLaboratorio de Inmunobiología de la Tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER) "Ismael Cosío Villegas," CDMX, México.ORCID 0000-0001-6226-6056
Esmeralda JuárezDepartamento de Investigación en Microbiología, INER "Ismael Cosío Villegas," CDMX, México.ORCID 0000-0001-9036-004X
Horacio Zamudio-MezaLaboratorio de Inmunobiología de la Tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER) "Ismael Cosío Villegas," CDMX, México.ORCID 0000-0002-8456-2881
Laura E Carreto-BinaghiLaboratorio de Inmunobiología de la Tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER) "Ismael Cosío Villegas," CDMX, México.ORCID 0000-0003-0356-4138
Mercedes ViettriLaboratorio de Inmunobiología de la Tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER) "Ismael Cosío Villegas," CDMX, México.ORCID 0000-0002-3290-2952
Damaris Romero-RodríguezUnidad de Citometría, INER "Ismael Cosío Villegas," CDMX, México.ORCID 0000-0003-1936-0279
Andrea PalenciaLaboratorio de Inmunobiología de la Tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER) "Ismael Cosío Villegas," CDMX, México.ORCID 0009-0005-3264-3785
David Sarfati-MizrahiLaboratorio Avi-Mex S.A. de C.V., CDMX, México.ORCID 0009-0002-6558-6316
Weina SunDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-2435-5047
Héctor Elías Chagoya-CortésConsultora Mextrategy S.A.S. de C.V., CDMX, México.ORCID 0009-0006-2786-4724
Felipa Castro-PeraltaLaboratorio Avi-Mex S.A. de C.V., CDMX, México.
Peter PaleseDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-0337-5823
Florian KrammerDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0003-4121-776X
Adolfo García-SastreDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-6551-1827
Bernardo Lozano-DubernardLaboratorio Avi-Mex S.A. de C.V., CDMX, México.ORCID 0009-0009-6430-7080

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Low- and middle-income countries face substantial challenges in immunizing against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including high costs, limited access, and insufficient local manufacturing. To address these issues, we developed and locally manufactured the AVX/COVID-12 vaccine using a cost-effective Newcastle disease virus LaSota platform to express a stabilized SARS-CoV-2 spike protein (HexaPro-S). We evaluated the AVX/COVID-12 vaccine in a phase 2/3 parallel-group, double-blind, active-controlled, noninferiority trial with 4056 volunteers, demonstrating its safety, good tolerability, and ability to induce neutralizing antibodies against ancestral SARS-CoV-2 and the Omicron BA.2 and BA.5 variants. It also stimulated interferon-γ-producing CD8

Indexed as

COVID-19COVID-19 VaccinesImmunogenicity, VaccineSARS-CoV-2AdolescentAdultAntibodies, NeutralizingAntibodies, ViralCD8-Positive T-LymphocytesDouble-Blind MethodFemaleHumansImmunization, SecondaryMaleMiddle AgedSpike Glycoprotein, CoronavirusAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2

Identifiers

PMID40577471
PMCPMC12204155

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.