Trial reportPloS one2014
Therapeutic vaccination with TNF-Kinoid in TNF antagonist-resistant rheumatoid arthritis: a phase II randomized, controlled clinical trial.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01040715 (A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological Therapy), which is not on this map. Cited by 24 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 Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological Therapy
Who cites it
24 citing papers in PubMed, 43 citations in OpenAlex.
- Immunization with detoxified TNFα elicits neutralizing antibodies and ameliorates inflammatory shock and autoimmune arthritis in mice.Frontiers in immunology · 2026Article
- Targeting rheumatoid arthritis: a molecular perspective on biologic therapies and clinical progress.Journal of biological engineering · 2025Review
- Engaging natural antibody responses for the treatment of inflammatory bowel disease via phosphorylcholine-presenting nanofibres.Nature biomedical engineering · 2024Article
- Vaccination therapy for inflammatory bowel disease.Human vaccines & immunotherapeutics · 2023Review
- Self-assembling peptides as immunomodulatory biomaterials.Frontiers in bioengineering and biotechnology · 2023Review
- A novel therapeutic vaccine targeting the soluble TNFα receptor II to limit the progression of cardiovascular disease: AtheroVax™.Frontiers in cardiovascular medicine · 2023Review
- Immunogenicity profile in African green monkeys of a vaccine candidate based on a mutated form of human Interleukin-15.BMC immunology · 2021Article
- Modelling the linkage between influenza infection and cardiovascular events via thrombosis.Scientific reports · 2020Article
- Peptide-Based Vaccination Therapy for Rheumatic Diseases.Journal of immunology research · 2020Review
- Potential Vaccines for Treating Crohn's DiseaseIranian biomedical journal · 2020Review
- Multifactorial Design of a Supramolecular Peptide Anti-IL-17 Vaccine Toward the Treatment of Psoriasis.Frontiers in immunology · 2020Article
- A New Venue of TNF Targeting.International journal of molecular sciences · 2018Review
- PDGF signaling pathway in hepatic fibrosis pathogenesis and therapeutics (Review).Molecular medicine reports · 2017Review
- Active immunotherapy for TNF-mediated inflammation using self-assembled peptide nanofibers.Biomaterials · 2017Article
- Is Graves' disease a primary immunodeficiency? New immunological perspectives on an endocrine disease.BMC medicine · 2017Review
- CD20-Mimotope Peptide Active Immunotherapy in Systemic Lupus Erythematosus and a Reappraisal of Vaccination Strategies in Rheumatic Diseases.Clinical reviews in allergy & immunology · 2017Review
- Tumor Necrosis Factor-Alpha Targeting Can Protect against Arthritis with Low Sensitization to Infection.Frontiers in immunology · 2017Article
- IL-1 Vaccination Is Suitable for Treating Inflammatory Diseases.Frontiers in pharmacology · 2017Article
- Targeted vaccination against the bevacizumab binding site on VEGF using 3D-structured peptides elicits efficient antitumor activity.Proceedings of the National Academy of Sciences of the United States of America · 2016Article
- Active immunization with human interleukin-15 induces neutralizing antibodies in non-human primates.BMC immunology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesActive immunization, or vaccination, with tumor necrosis factor (TNF)-Kinoid (TNF-K) is a novel approach to induce polyclonal anti-TNF antibodies in immune-mediated inflammatory diseases. This study was performed to transfer the proof of concept obtained in mice model of rheumatoid arthritis (RA) into human. We designed a pilot study to demonstrate the feasibility of therapeutic vaccination in RA.
methodsThis was a phase IIa, placebo-controlled, multicenter study in adults with RA who previously experienced secondary failure of TNF antagonists. Patients were immunized intramuscularly with 2 or 3 doses of placebo (n = 10) or 90 (n = 6), 180 (n = 12), or 360 µg TNF-K (n = 12). The primary objective was to identify the best dose and schedule based on anti-TNF antibody titers. Clinical symptoms and safety were assessed during 12 months and solicited reactions for 7 days after each injection.
resultsThe highest anti-TNF antibody response was detected in patients immunized with 360 µg TNF-K and with 3 injections, although this difference was not significant with all other groups. Similar proportions of patients receiving TNF-K and placebo reported adverse events up to month 12. Serious adverse events were reported by 4 patients treated with TNF-K (13.3%) and 3 treated with placebo (30.0%), all unrelated to treatment. At month 12, DAS28-CRP, tender and swollen joint counts, and HAQ scores decreased significantly more in patients who exhibited anti-TNF antibody response than in patients who did not.
conclusionsTNF-K therapeutic vaccination induced dose- and schedule-dependent anti-TNF antibodies in RA patients and was well tolerated. Patients who developed anti-TNF antibodies showed a trend toward clinical improvement. Although the most aggressive dose and schedule, i.e. 360 mg dose administered 3 times, did show a strong trend of higher antibody response, further studies are warranted to examine even higher and more frequent doses in order to establish the best conditions for clinical improvement.
trial registrationClinicalTrials.gov NCT01040715.
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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.