Trial reportCancer immunology, immunotherapy : CII2010
Clinical and immunological responses in metastatic melanoma patients vaccinated with a high-dose poly-epitope vaccine.
Trial report in Cancer immunology, immunotherapy : CII, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02485912 (A Phase Ib Safety and Immunogenicity Clinical Trial of Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy Senegalese Adult Volunteers Aged 18-50 Years.), which is not on this map. Cited by 23 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.
A Phase Ib Safety and Immunogenicity Clinical Trial of Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy Senegalese Adult Volunteers Aged 18-50 Years.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.
- Is the "3+3" dose-escalation phase I clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014Pooled it
- Protective CD8+ T-cell immunity to human malaria induced by chimpanzee adenovirus-MVA immunisation.Nature communications · 2013Trial
- Trial
- Analysis of pre-treatment markers predictive of treatment benefit for the therapeutic cancer vaccine MVA-5T4 (TroVax).Cancer immunology, immunotherapy : CII · 2012Trial
- Constant regulation for stable CD8 T-cell functional avidity and its possible implications for cancer immunotherapy.European journal of immunology · 2021Review
- Toward QbD Process Understanding on DNA Vaccine Purification Using Design of Experiment.Frontiers in bioengineering and biotechnology · 2021Article
- Process Characterization by Definitive Screening Design Approach on DNA Vaccine Production.Frontiers in bioengineering and biotechnology · 2020Article
- High Peptide Dose Vaccination Promotes the Early Selection of Tumor Antigen-Specific CD8 T-Cells of Enhanced Functional Competence.Frontiers in immunology · 2019Article
- Article
- Preclinical and clinical development of DNA vaccines for prostate cancer.Urologic oncology · 2016Review
- Progress in the development of vaccines for hepatitis C virus infection.World journal of gastroenterology · 2015Review
- STING activator c-di-GMP enhances the anti-tumor effects of peptide vaccines in melanoma-bearing mice.Cancer immunology, immunotherapy : CII · 2015Article
- Elements in the Development of a Production Process for Modified Vaccinia Virus Ankara.Microorganisms · 2013Review
- Trial watch: DNA vaccines for cancer therapy.Oncoimmunology · 2013Article
- Phase I trial of recombinant modified vaccinia ankara encoding Epstein-Barr viral tumor antigens in nasopharyngeal carcinoma patients.Cancer research · 2013Article
- Deletion of specific immune-modulatory genes from modified vaccinia virus Ankara-based HIV vaccines engenders improved immunogenicity in rhesus macaques.Journal of virology · 2012Article
- Therapeutic cancer vaccines in prostate cancer: the quest for intermediate markers of response.Cancers · 2012Article
- Elevated tumor-associated antigen expression suppresses variant peptide vaccine responses.Journal of immunology (Baltimore, Md. : 1950) · 2011Article
- Vaccinia viruses: vaccines against smallpox and vectors against infectious diseases and tumors.Expert review of vaccines · 2011Review
- Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 10 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSafety and cellular immunogenicity of rising doses and varying regimens of a poly-epitope vaccine were evaluated in advanced metastatic melanoma. The vaccine comprised plasmid DNA and recombinant modified vaccinia virus Ankara (MVA) both expressing a string (Mel3) of seven HLA.A2/A1 epitopes from five melanoma antigens.
methodsForty-one HLA-A2 positive patients with stage III/IV melanoma were enrolled. Patient groups received one or two doses of DNA.Mel3 followed by escalating doses of MVA.Mel3. Immunisations then continued eight weekly in the absence of disease progression. Epitope-specific CD8+ T cell responses were evaluated using ex-vivo tetramer and IFN-gamma ELISPOT assays. Safety and clinical responses were monitored.
resultsPrime-boost DNA/MVA induced Melan-A-specific CD8+ T cell responses in 22/31 (71%) patients detected by tetramer assay. ELISPOT detected a response to at least one epitope in 10/31 (32%) patients. T cell responder rates were <50% with low-dose DNA/MVA, or MVA alone, rising to 91% with high-dose DNA/MVA. Among eight patients showing evidence of clinical benefit-one PR (24 months+), five SD (5 months+) and two mixed responses-seven had associated immune responses. Melan-A-tetramer+ immunity was associated with a median 8-week increase in time-to-progression (P = 0.037) and 71 week increase in survival (P = 0.0002) compared to non-immunity. High-dose vaccine was well tolerated. The only significant toxicities were flu-like symptoms and injection-site reactions.
conclusionsDNA.Mel3 and MVA.Mel3 in a prime-boost protocol generated high rates of immune response to melanoma antigen epitopes. The treatment was well tolerated and the correlation of immune responses with patient outcomes encourages further investigation.
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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.