ArticlemedRxiv : the preprint server for health sciences2022
Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico.
Article in medRxiv : the preprint server for health sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04871737 (Dose-escalation, Open-label, Non-randomized Phase I Study to Evaluate the Safety and Immunogenicity of Three Concentrations of a rNDV Vaccine Against SARS-CoV-2 Administered by the Intranasal and Intramuscular Route to Healthy Volunteers), which is not on this map. Cited by 2 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.
Dose-escalation, Open-label, Non-randomized Phase I Study to Evaluate the Safety and Immunogenicity of Three Concentrations of a rNDV Vaccine Against SARS-CoV-2 Administered by the Intranasal and Intramuscular Route to Healthy Volunteers
Who cites it
2 citing papers in PubMed, 26 citations in OpenAlex.
- Antigen Delivery Systems: Past, Present, and Future.Biomolecules & therapeutics · 2023Review
- Systematic In-Silico Evaluation of the Diagnostic Impact of Mpox Genome Variants in the Current Outbreak.Molecular diagnosis & therapy · 2023Article
Corrections and comments
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Authors and funding
33 authors at 7 institutions in 2 countries.
Funding
Abstract
There is still a need for safe, efficient and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). This vaccine candidate can be grown in embryonated eggs at low cost similar to influenza virus vaccines and it can also be administered intranasally, potentially to induce mucosal immunity. We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open label non-randomized non-placebo-controlled phase I clinical trial in Mexico in 91 volunteers. The primary objective of the trial was to assess vaccine safety and the secondary objective was to determine the immunogenicity of the different vaccine regimens. In the interim analysis reported here, the vaccine was found to be safe and the higher doses tested were found to be immunogenic when given intramuscularly or intranasally followed by intramuscular administration, providing the basis for further clinical development of the vaccine candidate. The study is registered under ClinicalTrials.gov identifier NCT04871737. Funding was provided by Avimex and CONACYT.
Identifiers
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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.