Evidence map›Paper›PMID 36105814›Full record

ArticleFrontiers in immunology2022

Effectiveness, safety, and immunogenicity of half dose ChAdOx1 nCoV-19 COVID-19 Vaccine: Viana project.

Valéria Valim, Olindo Assis Martins-Filho, Maria da Penha Gomes Gouvea, Luiz Antônio Bastos Camacho, Daniel Antunes Maciel Villela, Sheila Maria Barbosa de Lima, Adriana Souza Azevedo, Lauro Ferreira Pinto Neto, Carla Magda Allan Santos Domingues, Nésio Fernandes de Medeiros Junior and 6 more

Open access · goldAbstract readControlled Clinical TrialEquivalence Trial
In one paragraph

Article in Frontiers in immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. 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

16 authors at 4 institutions in 1 country.

Valéria ValimHospital Universitário Cassiano Antônio Moraes [HUCAM-UFES/ Empresa de Serviços Hospitalares (EBSERH)] and Programa de Pós Graduação em Saúde Coletiva (PPGSC), Universidade Federal do Espírito Santo, Vitória, Brazil.
Olindo Assis Martins-FilhoGrupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz (FIOCRUZ-Minas), Belo Horizonte, Brazil.
Maria da Penha Gomes GouveaHospital Universitário Cassiano Antônio Moraes [HUCAM-UFES/ Empresa de Serviços Hospitalares (EBSERH)] and Programa de Pós Graduação em Saúde Coletiva (PPGSC), Universidade Federal do Espírito Santo, Vitória, Brazil.
Luiz Antônio Bastos CamachoEscola Nacional de Saúde Pública, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.
Daniel Antunes Maciel VillelaPrograma de Computação Científica (PROCC), Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.
Sheila Maria Barbosa de LimaLaboratório de Tecnologia Virológica (LATEV) (Bio-Manguinhos), Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.
Adriana Souza AzevedoLaboratório de Tecnologia Virológica (LATEV) (Bio-Manguinhos), Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.
Lauro Ferreira Pinto NetoEscola Superior de Ciências da Santa Casa de Misericórdia de Vitória (EMESCAM), Vitória, Brazil.
Carla Magda Allan Santos DominguesExternal Consultant, Independent Researcher, Vitória, Brazil.
Nésio Fernandes de Medeiros JuniorDepartamento de Educação Integrada em Saúde, Secretaria de Estado da Saúde do Espírito Santo (SESA), Vitória, Brazil.
Isac Ribeiro MoulazHospital Universitário Cassiano Antônio Moraes, Universidade Federal do Espírito Santo [HUCAM-UFES/ Empresa de Serviços Hospitalares (EBSERH)], Vitória, Brazil.
Laiza Hombre DiasHospital Universitário Cassiano Antônio Moraes, Universidade Federal do Espírito Santo [HUCAM-UFES/ Empresa de Serviços Hospitalares (EBSERH)], Vitória, Brazil.
Samira Tatiyama MiyamotoDepartamento de Educação Integrada em Saúde, Universidade Federal do Espírito Santo (DEIS/UFES), Vitória, Brazil.
Andréa Teixeira-CarvalhoGrupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz (FIOCRUZ-Minas), Belo Horizonte, Brazil.
José Geraldo MillHospital Universitário Cassiano Antônio Moraes [HUCAM-UFES/ Empresa de Serviços Hospitalares (EBSERH)] and Departamento de Ciências Fisiológicas, Universidade Federal do Espírito Santo, Vitória, Brazil.
Half Dose ChAdOx Study Group
Fundação Oswaldo Cruz · BRUniversidade Federal do Espírito Santo · BREscola Superior de Ciências da Santa Casa de Misericórdia de Vitória · BRSecretaria da Saúde · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fractional dose is an important strategy to increase access to vaccines. This study evaluated the effectiveness, safety, and immunogenicity of half dose of ChAdOx1 nCoV-19 vaccine. A non-inferiority non-randomized controlled trial compared a half dose of ChAdOx1 nCoV-19 with the full dose, with an interval of 8 to 10 weeks, in individuals aged 18-49 years. The primary endpoints were the incidence rate of new cases/1,000 person-year at 90 days after 14 days of the second dose, confirmed by RT-PCR and new cases registered at SUS National Health Surveillance Database (e-SUS VS). The anti-SARS-CoV-2 spike (S) protein receptor binding domain (RBD) by chemiluminescence and the neutralizing antibodies by plaque reduction neutralization test (PRNT) were titrated. The soluble biomarkers were quantified with a multiplex immunoassay. Follow-up was 90 days after 14 days of the second dose. A total of 29,598 individuals were vaccinated. After exclusion, 16,570 individuals who received half a dose and 6,402 who received full doses were analyzed. The incidence of new cases confirmed by RT-PCR of half dose was non-inferior to full dose (23.7 vs. 25.7 cases per 1,000 persons-year [coefficient group -0.09 CI95%(-0.49 to 0.31)], even after adjusting for age and sex. There were no deaths or hospitalization after immunization of either group. Immunogenicity was evaluated in a subsample (N=558) compared to 154 healthcare workers who received a full dose. The seroconversion rate in seronegative individuals at baseline half dose was 99.8%, similar to that of the full dose (100%). Geometric mean concentration (95% CI; BAU/mL) were half dose = 188 (163-217) and full dose = 529 (423-663) (p < 0.001). In seropositive subjects at baseline (pre-immune individuals), the first dose induced very high and similar IgG-S in half dose 1,359 (1,245-1,483) and full dose 1,354 (1,048-1,749) BAU/mL. A half dose induced a high increase in plasma chemokines, pro-inflammatory/regulatory cytokines, and growth factors. The frequency of adverse events was similar. No serious adverse events or deaths were reported. A half dose of ChAdOx1 nCoV-19 is as effective, safe, and immunogenic as the full dose. The immune response in pre-immune (seropositive in the baseline) individuals indicates that the half dose may be a booster dose schedule.

Indexed as

ChAdOx1 nCoV-19COVID-19COVID-19 VaccinesAntibodies, NeutralizingAntibodies, ViralHumansAntibodies, NeutralizingAntibodies, ViralChAdOx1 nCoV-19COVID-19 VaccinesChAdOx1COVID-19effectivenessfractional doseimmunogenicitysafetyvaccine

Identifiers

PMID36105814
PMCPMC9464812
OpenAlexW4295905234

What OpenQuestion holds

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Registered trials

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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.