Trial reportEmerging microbes & infections2021
Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial.
Trial report in Emerging microbes & infections, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 6 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 6 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022Pooled it
- Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis.BMC medicine · 2022Pooled it
- Immunologic response, Efficacy, and Safety of Vaccines against COVID-19 Infection in Healthy and immunosuppressed Children and Adolescents Aged 2 - 21 years old: A Systematic Review and Meta-analysis.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2022Pooled it
- A systematic review on mucocutaneous presentations after COVID-19 vaccination and expert recommendations about vaccination of important immune-mediated dermatologic disorders.Dermatologic therapy · 2022Pooled it
- Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis.The journal of headache and pain · 2022Pooled it
- Efficacy, immunogenicity and safety of COVID-19 vaccines in older adults: a systematic review and meta-analysis.Frontiers in immunology · 2022Pooled it
- Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial.Emerging microbes & infections · 2022Trial
- Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine.BMC medicine · 2022Trial
- Targeted FcRn to deliver epitope-optimized RBD confers broad-spectrum mucosal protection against SARS-CoV-2.Molecular therapy. Nucleic acids · 2026Article
- Immunosenescence and Vaccine Efficacy in Aging: Dynamic Interplay of Gut Microbiota and mTOR Signaling Pathways.Aging cell · 2026Review
- Use of Adjuvant Compositions Based on Squalene Ensures Induction of Neutralizing Antibodies against SARS-CoV-2.Bulletin of experimental biology and medicine · 2024Article
- Spike substitution T813S increases Sarbecovirus fusogenicity by enhancing the usage of TMPRSS2.PLoS pathogens · 2023Article
- An overview of the vaccine platforms to combat COVID-19 with a focus on the subunit vaccines.Progress in biophysics and molecular biology · 2023Review
- Article
- Advanced Vaccine Design Strategies against SARS-CoV-2 and Emerging Variants.Bioengineering (Basel, Switzerland) · 2023Review
- Recombinant Protein Vaccines against Human Betacoronaviruses: Strategies, Approaches and Progress.International journal of molecular sciences · 2023Review
- A self-binding immune complex vaccine elicits strong neutralizing responses against herpes simplex virus in mice.Frontiers in immunology · 2023Article
- The Bivalent COVID-19 Booster Immunization after Three Doses of Inactivated Vaccine Augments the Neutralizing Antibody Response against Circulating Omicron Sublineages.Journal of clinical medicine · 2022Article
- Article
- Efficacy and safety of COVID-19 vaccines: A network meta-analysis.Journal of evidence-based medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Safe and effective vaccines are still urgently needed to cope with the ongoing COVID-19 pandemic. Recently, we developed a recombinant COVID-19 vaccine (V-01) containing fusion protein (IFN-PADRE-RBD-Fc dimer) as antigen verified to induce protective immunity against SARS-CoV-2 challenge in pre-clinical study, which supported progression to Phase I clinical trials in humans. A Randomized, double-blind, placebo-controlled Phase I clinical trial was initiated at the Guangdong Provincial Center for Disease Control and Prevention (Gaozhou, China) in February 2021. Healthy adults aged between 18 and 59 years and over 60 years were sequentially enrolled and randomly allocated into three subgroups (1:1:1) either to receive the vaccine (10, 25, and 50 μg) or placebo (V-01: Placebo = 4:1) intramuscularly with a 21-day interval by a sentinel and dose escalation design. The data showed a promising safety profile with approximately 25% vaccine-related overall adverse events (AEs) within 30 days and no grade 3 or worse AEs. Besides, V-01 provoked rapid and strong immune responses, elicited substantially high-titre neutralizing antibodies and anti-RBD IgG peaked at day 35 or 49 after first dose, presented with encouraging immunogenicity at low dose (10 μg) subgroup and elderly participants, which showed great promise to be used as all-aged (18 and above) vaccine against COVID-19. Taken together, our preliminary findings indicate that V-01 is safe and well tolerated, capable of inducing rapid and strong immune responses, and warrants further testing in Phase II/III clinical trials.
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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.