Trial reportThe Journal of infection2022
Safety and immunogenicity of the inactivated whole-virus adjuvanted COVID-19 vaccine VLA2001: A randomized, dose escalation, double-blind phase 1/2 clinical trial in healthy adults.
Trial report in The Journal of infection, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04671017 (A Phase I/II Randomized, Two Parts, Dose-Finding Study To Evaluate The Safety, Tolerability and Immunogenicity Of An Inactivated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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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 Phase I/II Randomized, Two Parts, Dose-Finding Study To Evaluate The Safety, Tolerability and Immunogenicity Of An Inactivated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate (VLA2001), Against Covid-19 In Healthy Subjects
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles: A Systematic Review.JAMA network open · 2023Pooled it
- Trial
- Immunogenicity and safety of an inactivated whole-virus COVID-19 vaccine (VLA2001) compared with the adenoviral vector vaccine ChAdOx1-S in adults in the UK (COV-COMPARE): interim analysis of a randomised, controlled, phase 3, immunobridging trial.The Lancet. Infectious diseases · 2022Trial
- Moloney Murine Leukemia Virus-like Nanoparticles Pseudo-Typed with SARS-CoV-2 RBD for Vaccination Against COVID-19.International journal of molecular sciences · 2025Article
- Review
- Heterologous prime-boost vaccination with VLA2001 and an ORFV-based vector enhances spike- and nucleocapsid-specific immunity in mice.Frontiers in immunology · 2025Article
- Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens.Vaccines · 2024Article
- Review
- The role of vaccines in the COVID-19 pandemic: what have we learned?Seminars in immunopathology · 2024Review
- Global Emergence of SARS-CoV2 Infection and Scientific Interventions to Contain its Spread.Current protein & peptide science · 2024Review
- Vector-based SARS-CoV-2 vaccination is associated with improved T-cell responses in hematological neoplasia.Blood advances · 2023Article
- Dynamics of immune responses to inactivated COVID-19 vaccination over 8 months in China.The Journal of infection · 2023Article
- T cell immune memory after covid-19 and vaccination.BMJ medicine · 2023Review
- Novel coronavirus mutations: Vaccine development and challenges.Microbial pathogenesis · 2022Review
- Recent review of COVID-19 management: diagnosis, treatment and vaccination.Pharmacological reports : PR · 2022Review
Corrections and comments
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Authors and funding
27 authors.
Funding
Abstract
objectivesWe aimed to evaluate the safety and optimal dose of a novel inactivated whole-virus adjuvanted vaccine against SARS-CoV-2: VLA2001.
methodsWe conducted an open-label, dose-escalation study followed by a double-blind randomized trial using low, medium and high doses of VLA2001 (1:1:1). The primary safety outcome was the frequency and severity of solicited local and systemic reactions within 7 days after vaccination. The primary immunogenicity outcome was the geometric mean titre (GMT) of neutralizing antibodies against SARS-CoV-2 two weeks after the second vaccination. The study is registered as NCT04671017.
resultsBetween December 16, 2020, and June 3, 2021, 153 healthy adults aged 18-55 years were recruited in the UK. Overall, 81.7% of the participants reported a solicited AE, with injection site tenderness (58.2%) and headache (46.4%) being the most frequent. Only 2 participants reported a severe solicited event. Up to day 106, 131 (85.6%) participants had reported any AE. All observed incidents were transient and non-life threatening in nature. Immunogenicity measured at 2 weeks after completion of the two-dose priming schedule, showed significantly higher GMTs of SARS-CoV-2 neutralizing antibody titres in the highest dose group (GMT 545.6; 95% CI: 428.1, 695.4) which were similar to a panel of convalescent sera (GMT 526.9; 95% CI: 336.5, 825.1). Seroconversion rates of neutralizing antibodies were also significantly higher in the high-dose group (>90%) compared to the other dose groups. In the high dose group, antigen-specific IFN-γ expressing T-cells reactive against the S, M and N proteins were observed in 76, 36 and 49%, respectively.
conclusionsVLA2001 was well tolerated in all tested dose groups, and no safety signal of concern was identified. The highest dose group showed statistically significantly stronger immunogenicity with similar tolerability and safety, and was selected for phase 3 clinical development.
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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.