Evidence map›Paper›PMID 41398275›Full record

Trial reportBMC medicine2025

A booster dose of an inactivated SARS-CoV-2 vaccine targeting virus variants sustains protective humoral and cellular immunity.

Constanza Méndez, Linmar Rodríguez-Guilarte, Pablo A Palacios, Cristian Gutierrez-Vera, Francisca Román, Daniela Moreno-Tapia, Mariana Ríos, Antonia Reyes, Felipe A Cancino, Francisco F Otero and 30 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05593042 (Phase 2, Randomized, Double-blind Study to Evaluate Immunogenicity Superiority of a Booster Dose With an Omicron or a Trivalent Vaccine Compared to CoronaVac, in Adults Immunized With Different Vaccine Schedules Against SARS-CoV-2 in Chile), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT05593042 phase2completednot on this map

Phase 2, Randomized, Double-blind Study to Evaluate Immunogenicity Superiority of a Booster Dose With an Omicron or a Trivalent Vaccine Compared to CoronaVac, in Adults Immunized With Different Vaccine Schedules Against SARS-CoV-2 in Chile

TypeinterventionalSponsorPontificia Universidad Catolica de ChileRan2022 to 2023Enrolled551ConditionsCOVID-19, VaccinesArmsCoronaVac®, Omicron Vaccine, Trivalent Vaccine
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

40 authors.

Constanza MéndezMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Linmar Rodríguez-GuilarteMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Pablo A PalaciosMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Cristian Gutierrez-VeraMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Francisca RománMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Daniela Moreno-TapiaMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Mariana RíosMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Antonia ReyesMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Felipe A CancinoMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Francisco F OteroMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Constanza ZuritaMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Daniela RiveraMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Alex CabreraUnidad de Citometría de Flujo, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile.
Luisa F DuarteMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Marcela UrzúaDivisión de Pediatría, Departamento de Enfermedades Infecciosas E Inmunología Pediátricas, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Carolina IturriagaDivisión de Pediatría, Departamento de Enfermedades Infecciosas E Inmunología Pediátricas, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Álvaro RojasDivisión de Medicina, Departamento de Enfermedades Infecciosas del Adulto, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Carlos M PerezFacultad de Medicina y Ciencia, Universidad San Sebastián, Santiago, Chile.
Andrea Schilling RedlichFacultad de Medicina Clínica Alemana, Universidad del Desarrollo, Santiago, Chile.
Rodrigo A FasceDepartamento de Laboratorio Biomédico, Instituto de Salud Pública de Chile, Santiago, Chile.
Jorge FernándezDepartamento de Laboratorio Biomédico, Instituto de Salud Pública de Chile, Santiago, Chile.
Judith MoraDepartamento de Laboratorio Biomédico, Instituto de Salud Pública de Chile, Santiago, Chile.
Eugenio RamírezDepartamento de Laboratorio Biomédico, Instituto de Salud Pública de Chile, Santiago, Chile.
Angélica DomínguezSchool of Public Health, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Daniela WeiskopfCenter for Vaccine Innovation, La Jolla Institute for Immunology, La Jolla, San Diego, CA, USA.
Alba GrifoniCenter for Vaccine Innovation, La Jolla Institute for Immunology, La Jolla, San Diego, CA, USA.
Alessandro SetteCenter for Vaccine Innovation, La Jolla Institute for Immunology, La Jolla, San Diego, CA, USA.
Gang ZengSinovac Biotech, Beijing, China.
Weining MengSinovac Biotech, Beijing, China.
David GoldbattGreat Ormond Street Institute of Child Health, University College London, London, UK.
Marina JohnsonGreat Ormond Street Institute of Child Health, University College London, London, UK.
CoronaVarCL study group
José V González-AramundizEscuela de Farmacia, Facultad de Química y de Farmacia, Pontificia Universidad Católica de Chile, Santiago, Chile.
María J Álvarez-FigueroaEscuela de Farmacia, Facultad de Química y de Farmacia, Pontificia Universidad Católica de Chile, Santiago, Chile.
Katia AbarcaMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Leandro J CarreñoMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Pablo A GonzálezMillennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Alexis M KalergisMillennium Institute on Immunology and Immunotherapy, Santiago, Chile. akalergis@uc.cl.
Hernán F PeñalozaMillennium Institute on Immunology and Immunotherapy, Santiago, Chile. hfpenalo@uc.cl.
Susan M BuenoMillennium Institute on Immunology and Immunotherapy, Santiago, Chile. sbuenor@uc.cl.

Funding

NIAID Centers of Excellence for Influenza Research and Response: Universal Influenza Vaccine Research Activities75N93021C00016 · NIAID · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI WEBBY, RICHARD · 2021 to 2025
$91.4M
Large Scale T Cell Epitope Discovery:Global identification of epitopes derived from Zika (ZIKV), Chikungunya (CHIKV) viruses following natural infection and vaccination75N93019C00065 · NIAID · LA JOLLA INSTITUTE FOR IMMUNOLOGY · PI MITCHELL, MAYA · 2019 to 2023
$7.3M
Fondo de Innovación para la Competitividad BIP Code: 30488811-0Millennium Institute on Immunology and Immunotherapy ICN09_016 / ICN 2021_045; former P09/016-FNational Institute of Allergy and Infectious Diseases 75N9301900065NIAID NIH HHS 75N93019C00065NIAID NIH HHS 75N93021C00016
6 · The paper itself

Abstract

backgroundThe Omicron lineage of SARS-CoV-2 showed a remarkable ability to escape vaccine-induced immunity. In a Phase 2 clinical trial, we investigated whether a third booster/fifth dose of one of three inactivated SARS-CoV-2 vaccine candidates, based on the Delta and Omicron BA.1 variants, enhanced humoral and cellular immune responses against SARS-CoV-2.

methodsVolunteers who received either four doses of CoronaVac® (homologous group, n = 228) or two doses of CoronaVac® followed by two mRNA vaccine doses (heterologous group, n = 298) were randomly assigned to receive an Omicron BA.1-based, trivalent (ancestral, Delta, Omicron BA.1) inactivated vaccine or an additional dose of CoronaVac® (heterologous group only). Local and systemic adverse events were recorded for 7 days after immunization with the fifth dose. Blood samples were collected at the time of immunization (day 0), 28 days post-immunization, and 180 days post-immunization. The immune response induced by vaccination was evaluated by quantifying total IgG against SARS-CoV-2 and neutralizing antibodies, IgG-producing B cells, relative antibody avidity, SARS-CoV-2-specific CD4

resultsThe most common local adverse event was pain at the site of inoculation (deltoid area), reported in 43.2% of the participants. No severe adverse events related to vaccination were recorded. Increased SARS-CoV-2-specific IgGs were observed exclusively in the homologous group at 28 days post-vaccination compared to the pre-immune status. Reduced neutralizing antibodies against the Omicron BA.1 variant were detected in both groups when compared to the ancestral (WT) virus, and no changes in IgG-producing B cells or relative antibody avidity were observed after vaccination. Furthermore, we observed sustained IFN-γ production and the frequency of SARS-CoV-2-specific CD4

conclusionsPrevious immunizations targeting the WT SARS-CoV-2 virus have induced a robust humoral and cellular response in the population, which is sustained by a fifth dose targeting either the Omicron BA.1, Delta, or WT virus.

trial registrationNo. NCT05593042.

Indexed as

COVID-19COVID-19 VaccinesImmunity, CellularImmunity, HumoralImmunization, SecondarySARS-CoV-2AdolescentAdultAntibodies, NeutralizingAntibodies, ViralFemaleHumansImmunoglobulin GMaleMiddle AgedVaccines, InactivatedAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesImmunoglobulin GSARS-CoV-2 inactivated vaccinesVaccines, InactivatedCellular immunityFifth dose vaccineHumoral immunityInactivated vaccineOmicron variantSARS-CoV-2

Identifiers

PMID41398275
PMCPMC12822000

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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.