ArticlemBio2021
Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs.
Article in mBio, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05710783 (Phase II/III Parallel, Double-blind, Non-inferiority Study With Active Control, to Evaluate the Immunogenicity and Safety of a Booster Immunization Scheme With a Single Intramuscular Dose of the Recombinant Vaccine Against SARS-CoV-2), which is not on this map. Cited by 36 papers.
What it found
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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.
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.
Phase II/III Parallel, Double-blind, Non-inferiority Study With Active Control, to Evaluate the Immunogenicity and Safety of a Booster Immunization Scheme With a Single Intramuscular Dose of the Recombinant Vaccine Against SARS-CoV-2
Who cites it
36 citing papers in PubMed, 53 citations in OpenAlex.
- Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine.Science advances · 2025Trial
- The buried S2 apex of SARS-CoV-2 spike elicits an immunodominant germline-restricted public antibody response.bioRxiv : the preprint server for biology · 2026Article
- Development of an RT-qPCR and a Next-Generation Sequencing approach to assess viral shedding of NDV-based SARS-CoV-2 variant vaccines.Microbiology spectrum · 2026Article
- Review
- Addressing SARS-CoV-2 evolution: neutralization of emerging variants of concern by the AVX/COVID-12 'Patria' vaccine based on HexaPro-S ancestral Wuhan spike or its updated BA.2.75.2 version.Frontiers in immunology · 2025Article
- Mucosal multivalent NDV-based vaccine provides cross-reactive immune responses against SARS-CoV-2 variants in animal models.Frontiers in immunology · 2025Article
- Immunogenicity of intranasal vaccine based on SARS-CoV-2 spike protein during primary and booster immunizations in mice.Human vaccines & immunotherapeutics · 2024Article
- Protective effect and molecular mechanisms of human non-neutralizing cross-reactive spike antibodies elicited by SARS-CoV-2 mRNA vaccination.Cell reports · 2024Article
- Mucosal Vaccination with a Newcastle Disease Virus-Vectored Vaccine Reduces Viral Loads in SARS-CoV-2-Infected Cynomolgus Macaques.Vaccines · 2024Article
- Protective effect and molecular mechanisms of human non-neutralizing cross-reactive spike antibodies elicited by SARS-CoV-2 mRNA vaccination.bioRxiv : the preprint server for biology · 2024Article
- Negative-Strand RNA Virus-Vectored Vaccines.Methods in molecular biology (Clifton, N.J.) · 2024Review
- Newcastle disease virus vector-based SARS-CoV-2 vaccine candidate AVX/COVID-12 activates T cells and is recognized by antibodies from COVID-19 patients and vaccinated individuals.Frontiers in immunology · 2024Article
- Safety evaluation of recombinant Newcastle disease virus expressing IBV multi-epitope chimeric live vaccine.Frontiers in microbiology · 2024Article
- Advantages and challenges of Newcastle disease virus as a vector for respiratory mucosal vaccines.Current opinion in virology · 2023Review
- Promises and challenges of mucosal COVID-19 vaccines.Vaccine · 2023Article
- Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico.NPJ vaccines · 2023Article
- Viral vectored vaccines: design, development, preventive and therapeutic applications in human diseases.Signal transduction and targeted therapy · 2023Review
- Evaluation and deployment of isotype-specific salivary antibody assays for detecting previous SARS-CoV-2 infection in children and adults.Communications medicine · 2023Article
- Immunization with matrix-, nucleoprotein and neuraminidase protects against H3N2 influenza challenge in pH1N1 pre-exposed pigs.NPJ vaccines · 2023Article
- From Immunogen to COVID-19 vaccines: Prospects for the post-pandemic era.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2023Review
Corrections and comments
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Authors and funding
19 authors at 2 institutions in 2 countries.
Funding
Abstract
Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed in record time and show excellent efficacy and effectiveness against coronavirus disease 2019 (COVID-19). However, currently approved vaccines cannot meet the global demand. In addition, none of the currently used vaccines is administered intranasally to potentially induce mucosal immunity. Here, we tested the safety and immunogenicity of a second-generation SARS-CoV-2 vaccine that includes a stabilized spike antigen and can be administered intranasally. The vaccine is based on a live Newcastle disease virus vector expressing a SARS-CoV-2 spike protein stabilized in a prefusion conformation with six beneficial proline substitutions (AVX/COVID-12-HEXAPRO; Patria). Immunogenicity testing in the pig model showed that both intranasal and intramuscular application of the vaccine as well as a combination of the two induced strong serum neutralizing antibody responses. Furthermore, substantial reactivity to B.1.1.7, B.1.351, and P.1 spike variants was detected. Finally, no adverse reactions were found in the experimental animals at any dose level or delivery route. These results indicate that the experimental vaccine AVX/COVID-12-HEXAPRO (Patria) is safe and highly immunogenic in the pig model.
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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.