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Table 1 Summary of prostate cancer DNA vaccination clinical trials

From: DNA vaccination for prostate cancer, from preclinical to clinical trials - where we stand?

References Antigen /+− co stimulatory molecules No. of patients/ patient’s characteristics Type of study Route of vaccination Immunological responses Adverse effects PSA response
[14] Extracellular human PSMA & CD86 into separate expression vectors (PSMA & CD86 ), and into a combined plasmid (PSMA/CD86) 26 Phase I/II i.d. - All patients who received initial inoculation with viral vector followed by PSMA plasmid boosts showed immunisation. In contrast, with PSMA and CD86 plasmids, only 50% were immunised. - -
+ Expression cassette from PSMA plasmid into a replication deficient adenoviral expression vector - Of the patients who received PSMA & GM-CSF, 67% were immunised. However, PSMA/CD86 & GM-CSF vaccination immunised all recipients.
[15] Plasmid vector expressing PSA & GM-CSF/IL-2 9 CRPC Phase I i.m, i.d. PSA-specific cellular immune response (measured by IFN- γ & anti-PSA IgG levels) were detected in highest dose cohort of patients. - Systemic effects; running nose, fatigue, myalgia, chills and fever (n = 6). - Drop in PSA (n=3).
- At the injection site; erythema, swelling, induration, itching, pain, urticaria (n = 7). - Increase in PSA (n= 5).
[56] Vaccine encoding a domain of fragment C of tetanus toxin fused to a tumour-derived epitope from PSMA 5 patients / dose level Phase I/II, i.m. or i.m. + EP Delivery of DNA+EP at all five vaccinations resulted in activation of humoral immunity. - Mild pain at injection site. -
Recurrent PCa - EP did not add toxicity.
[57] Vaccine encoding PAP co-administered with GM-CSF 22 Stage D0 PCa Phase I/IIa i.d. - Three of 22 patients developed PAP-specific IFN-γ secreting CD8+ T-cells. While 9 (41%) patients developed PAP-specific CD4+ and/or CD8+ T-cell proliferation. No significant adverse events PSA doubling time increased from a median 6.5 months per treatment to 8.5 months on-treatment & 9.3 months in one year post treatment.
- Antibody responses to PAP were not detected.
  1. PSMA Prostate Specific Membrane Antigen, CD 86 Cluster of Differentiation 86, i.d Intradermal, i.m Intramuscular, PSA Prostate Specific Antigen, GM-CSF Granulocyte-macrophage colony-stimulating factor, IL2 Interleukin 2, CRPC Castrate Resistant Prostate Cancer, IFN-γ Interferon Gamma, PCa Prostate Cancer, PAP Prostate Acid Phosphatase.