• Vaccine Name: Recombinant NY-ESO-1 Protein vaccine adjuvanted with Imiquimod
• Target Pathogen: Cancer
• Target Disease: Cancer
• Vaccine Ontology ID: VO_0004248
• Type: Subunit vaccine
• Status: Clinical trial
• Antigen: Recombinant, full-length NY-ESO-1 protein (Adams et al., 2008).
• CTAG1B gene engineering:
  • Type: Recombinant protein preparation
  • Description:
  • Detailed Gene Information: Click Here.
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0001328
• Immunization Route: Intradermal injection (i.d.)
• Description: Recombinant, full-length NY-ESO-1 protein was administered intradermally into imiquimod preconditioned sites followed by additional topical applications of imiquimod in patients with malignant melanoma (Adams et al., 2008).

Human Response

• Vaccination Protocol: Patients with histologically confirmed, resected malignant melanoma (American Joint Committee on Cancer (AJCC) stages (39) IIB, IIC, and III) were eligible, and 9 patients were enrolled in the study. Imiquimod cream (5%, 250 mg) was self-applied topically by patients to a 4 x 5-cm outlined area of healthy extremity skin overnight on days 1–5 of each cycle. Application and removal times were recorded in treatment diaries. Recombinant human NY-ESO-1 protein (100 µg in 4 M urea and 50 mM glycine, provided by the Ludwig Institute for Cancer Research) was injected intradermally into the imiquimod-treated site on day 3. Cycles were repeated every 3 wk for a total of four injections. Imiquimod was omitted on day 5 of the last cycle to avoid biopsy site irritation (Adams et al., 2008).
• Immune Response: NY-ESO-1-specific Ab responses were detected in 4 of 9 patients (44%). However, Ab titers were significantly lower than those described in a previous study using i.m. injection of NY-ESO-1 protein with the saponin-based adjuvant ISCOMATRIX (Adams et al., 2008).
• Side Effects: NY-ESO-1/imiquimod was well tolerated, and all patients completed the study. Treatment-related adverse events were mild and transient. Local reactions at the site of imiquimod application or vaccine injection were seen in 8 of 9 patients (89%). Four of 9 patients (44%) reported fatigue, and 2 of 9 patients (22%) experienced flu-like symptoms. All adverse events were grade 1 (CTC version 3.0) and were likely related to the immunomodulatory effects of imiquimod and vaccination (Adams et al., 2008).