Trial reportEBioMedicine2022
Safety and immunogenicity of a measles-vectored SARS-CoV-2 vaccine candidate, V591 / TMV-083, in healthy adults: results of a randomized, placebo-controlled Phase I study.
Trial report in EBioMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04497298 (A Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase), which is not on this map. Cited by 20 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.
A Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase
Who cites it
20 citing papers in PubMed, 31 citations in OpenAlex.
- Trial
- IRO-203: a novel intranasal COVID-19 vaccine showing immunogenicity and viral suppression in African green monkey challenge study.Scientific reports · 2026Article
- Minor differences in the untranslated regions of measles vector additional transcription units are reflected by differential immunogenicity of encoded MERS-CoV Spike antigen.Journal of virology · 2026Article
- The Functional DPP4 Receptor Is an Indispensable Factor Mediating the Immune Performance of Mucosal Vaccines for Middle East Respiratory Syndrome.Transboundary and emerging diseases · 2025Article
- Immunity and Protective Efficacy of a Plant-Based Tobacco Mosaic Virus-like Nanoparticle Vaccine against Influenza a Virus in Mice.Vaccines · 2024Article
- Emerging and reemerging infectious diseases: global trends and new strategies for their prevention and control.Signal transduction and targeted therapy · 2024Review
- Dynamics of measles immunity from birth and following vaccination.Nature microbiology · 2024Article
- A measles-vectored vaccine candidate expressing prefusion-stabilized SARS-CoV-2 spike protein brought to phase I/II clinical trials: candidate selection in a preclinical murine model.Journal of virology · 2024Article
- A measles-vectored vaccine candidate expressing prefusion-stabilized SARS-CoV-2 spike protein brought to phase I/II clinical trials: protection of African green monkeys from COVID-19 disease.Journal of virology · 2024Article
- Article
- Article
- Review
- Negative-Strand RNA Virus-Vectored Vaccines.Methods in molecular biology (Clifton, N.J.) · 2024Review
- A next-generation intranasal trivalent MMS vaccine induces durable and broad protection against SARS-CoV-2 variants of concern.Proceedings of the National Academy of Sciences of the United States of America · 2023Article
- Viral vectored vaccines: design, development, preventive and therapeutic applications in human diseases.Signal transduction and targeted therapy · 2023Review
- Recombinant measles virus expressing prefusion spike protein stabilized by six rather than two prolines is more efficacious against SARS-CoV-2 infection.Journal of medical virology · 2023Article
- A protective measles virus-derived vaccine inducing long-lasting immune responses against influenza A virus H7N9.NPJ vaccines · 2023Article
- Rapid protection induced by a single-shot Lassa vaccine in male cynomolgus monkeys.Nature communications · 2023Article
- Full-Lung Prophylaxis against SARS-CoV-2 by One-Shot or Booster Intranasal Lentiviral Vaccination in Syrian Golden Hamsters.Vaccines · 2022Article
- Versatility of live-attenuated measles viruses as platform technology for recombinant vaccines.NPJ vaccines · 2022Review
Corrections and comments
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Authors and funding
24 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundV591 (TMV-083) is a live recombinant measles vector-based vaccine candidate expressing a pre-fusion stabilized SARS-CoV-2 spike protein.
methodsWe performed a randomized, placebo-controlled Phase I trial with an unblinded dose escalation and a double-blind treatment phase at 2 sites in France and Belgium to evaluate the safety and immunogenicity of V591. Ninety healthy SARS-CoV-2 sero-negative adults (18-55 years of age) were randomized into 3 cohorts, each comprising 24 vaccinees and 6 placebo recipients. Participants received two intramuscular injections of a low dose vaccine (1 × 10
findingsBetween Aug 10 and Oct 13, 2020, 148 volunteers were screened of whom 90 were randomized. V591 showed a good safety profile at both dose levels. No serious adverse events were reported. At least one treatment-related adverse event was reported by 15 (20.8%) participants receiving V591 vs. 6 (33.3%) of participants receiving placebo. Eighty-one percent of participants receiving two injections of V591 developed spike-binding antibodies after the second injection. However, neutralizing antibodies were detectable on day 56 only in 17% of participants receiving the low dose and 61% receiving the high dose (2 injections). Spike-specific T cell responses were not detected. Pre-existing anti-measles immunity had a statistically significant impact on the immune response to V591, which was in contrast to previous results with the measles vector-based chikungunya vaccine.
interpretationWhile V591 was generally well tolerated, the immunogenicity was not sufficient to support further development.
fundingThemis Bioscience GmbH, a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA; Coalition for Epidemic Preparedness Innovations (CEPI).
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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.