ArticleNPJ vaccines2023
Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico.
Article in NPJ vaccines, 2023. 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 32 papers, 1 of them a synthesis that pooled 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.
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
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- Mucosal immunity and vaccine development.Signal transduction and targeted therapy · 2026Pooled it
- Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine.Science advances · 2025Trial
- Terminal V5 Tagging of All Four Newcastle Disease Virus Structural Proteins Is Compatible with Particle Formation in Sf9 Cells.International journal of molecular sciences · 2026Article
- A single-dose chimeric Newcastle disease virus (NDV)/chikungunya virus (CHIKV) is an effective CHIKV vaccine candidate.Journal of virology · 2026Article
- IRO-203: a novel intranasal COVID-19 vaccine showing immunogenicity and viral suppression in African green monkey challenge study.Scientific reports · 2026Article
- Intranasal vaccine combining adenovirus and trimeric subunit protein provides superior immunity against SARS-CoV-2 Omicron variant.Nature biomedical engineering · 2026Article
- Intranasal replicating adenovirus type 4-vectored SARS-CoV-2 vaccines induce durable and efficacious responses in preclinical testing.iScience · 2026Article
- Current status of intranasal and inhaled COVID-19 vaccines.NPJ vaccines · 2026Review
- Intranasal Replicating Adenovirus type 4-SARS-CoV-2 Recombinants Induce Superior Immune Response Durability and Efficacy in Preclinical Testing Compared to Standard Intramuscular Vaccines.bioRxiv : the preprint server for biology · 2026Article
- Article
- One year follow up of phase 1/2 randomized, placebo controlled trial of NDV-HXP-S vaccine in Thailand.NPJ vaccines · 2025Article
- Immunogenicity and efficacy of homologous and heterologous NDV and MVA SARS-CoV-2 vaccines in mice and hamsters.NPJ vaccines · 2025Article
- Mucosal immunity and vaccination strategies: current insights and future perspectives.Molecular biomedicine · 2025Review
- Safety and immunogenicity of intranasal parainfluenza virus type 5 (PIV5)-vectored COVID-19 vaccine in adults and teens in an open-label phase 1 trial.Science advances · 2025Article
- Efficacy of parainfluenza virus 5 (PIV5)-vectored intranasal COVID-19 vaccine as a single dose primer and booster against SARS-CoV-2 variants.Journal of virology · 2025Article
- Mucosal multivalent NDV-based vaccine provides cross-reactive immune responses against SARS-CoV-2 variants in animal models.Frontiers in immunology · 2025Article
- 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
- Newcastle disease virus expressing clade 2.3.4.4b H5 hemagglutinin confers protection against lethal H5N1 highly pathogenic avian influenza in BALB/c mice.Frontiers in veterinary science · 2025Article
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Corrections and comments
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Authors and funding
33 authors at 8 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 a 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.
Identifiers
What OpenQuestion holds
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.