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Vaccine Detail

Recombinant NY-ESO-1 ISCOMATRIX Vaccine
Vaccine Information
  • Vaccine Name: Recombinant NY-ESO-1 ISCOMATRIX Vaccine
  • Target Pathogen: Cancer
  • Target Disease: Cancer
  • Vaccine Ontology ID: VO_0004254
  • Type: Subunit vaccine
  • Status: Clinical trial
  • Antigen: Full-length recombinant NY-ESO-1 protein (Nicholaou et al., 2009).
  • CTAG1B gene engineering:
  • Adjuvant:
  • Immunization Route: Intramuscular injection (i.m.)
Host Response

Human Response

  • Vaccination Protocol: All patients received three injections of the NY-ESO-1 ISCOMATRIX vaccine at weeks 1, 5, and 9 (cycle 1) and were then evaluated for immunologic and clinical response. All patients had histologically confirmed stage IV (metastatic) or unresectable stage III malignant melanoma with measurable disease using Response Evaluation Criteria in Solid Tumors. The vaccine comprised 200 μg/mL of NY-ESO-1 protein formulated with 240 μg/mL ISCOMATRIX adjuvant and was administered in a 0.5 mL i.m. injection to deliver an intended dose of 100 μg NY-ESO-1 protein and 120 μg ISCOMATRIX adjuvant (Nicholaou et al., 2009).
  • Side Effects: There were no serious adverse events deemed to be related to study drug reported for this study and no grade 3 or 4 toxicities were observed. Only minor toxicities were reported in relation to administration of the NY-ESO-1 ISCOMATRIX vaccine, NY-ESO-1 protein, and peptides (Nicholaou et al., 2009).
  • Efficacy: No objective confirmed responses were seen in this study. These results were unexpected based on observations from patients in the prior LUD99-008 study of the NY-ESO-1 ISCOMATRIX vaccine in the MRD setting. In the LUD99-008 study, patients receiving effective vaccination had a significantly reduced probability of relapse compared with those who received placebo, suggesting that the vaccine may have had clinical efficacy in the setting of MRD (Nicholaou et al., 2009).
References
Nicholaou et al., 2009: Nicholaou T, Ebert LM, Davis ID, McArthur GA, Jackson H, Dimopoulos N, Tan B, Maraskovsky E, Miloradovic L, Hopkins W, Pan L, Venhaus R, Hoffman EW, Chen W, Cebon J. Regulatory T-cell-mediated attenuation of T-cell responses to the NY-ESO-1 ISCOMATRIX vaccine in patients with advanced malignant melanoma. Clinical cancer research : an official journal of the American Association for Cancer Research. 2009; 15(6); 2166-2173. [PubMed: 19276262].