Table 1 Summary of prostate cancer DNA vaccination clinical trials

[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.