• Vaccine Ontology ID: VO_0011507
• Type: Subunit vaccine
• Status: Clinical trial
• TERT gene engineering:
  • Type: Recombinant protein preparation
  • Detailed Gene Information: Click Here.
• Adjuvant:
  • VO ID: VO_0001294
  • Description: Granulocyte–macrophage colony-stimulating factor (Bernhardt et al., 2006).
• Immunization Route: Intradermal injection (i.d.)

• Vaccine Ontology ID: VO_0004428
• Type: DNA vaccine
• Status: Research
• Host Species as Laboratory Animal Model: Human
• S gene engineering:
  • Type: DNA vaccine construction
  • Description: Vector pcDNA3 expressed the small and middle proteins of the Hepatitis B surface antigen (Conry et al., 2002).
  • Detailed Gene Information: Click Here.
• CEACAM5 (CEA) gene engineering:
  • Type: DNA vaccine construction
  • Description: Vector pcDNA3 expressed the carcinoembryonic antigen (Conry et al., 2002).
  • Detailed Gene Information: Click Here.
• Vector: pcDNA3 (Conry et al., 2002)
• Immunization Route: Intramuscular injection (i.m.)

• Vaccine Ontology ID: VO_0004431
• Type: DNA vaccine
• Status: Research
• Host Species as Laboratory Animal Model: Human
• Tyrosinase gene engineering:
  • Type: DNA vaccine construction
  • Description: This DNA vaccine expressed two peptides, tyrosinase 207–216 and tyrosinase 1–17, both of which are derived from human tyrosinase (Tagawa et al., 2003).
  • Detailed Gene Information: Click Here.
• Immunization Route: Intramuscular injection (i.m.)

• Vaccine Ontology ID: VO_0004614
• Type: Dendritic cell
• Status: Research
• Antigen: tumor-associated antigens: antigen G250 with gp100 and tyrosinase protein, and pulsed with keyhole limped hemocyan (KLH) protein.
• CA9 gene engineering:
  • Type: Recombinant protein preparation
  • Description: (Aarntzen et al., 2012)
  • Detailed Gene Information: Click Here.
• Preparation: Monocyte-derived DC, electroporated with mRNA encoding gp100 and tyrosinase, were pulsed with keyhole limpet hemocyanin and administered intranodally (Aarntzen et al., 2012).
• Immunization Route: Intramuscular injection (i.m.)

• Vaccine Ontology ID: VO_0004609
• Type: anti-GRP DNA
• Status: Research
• Antigen: GRP
• Immunization Route: Intramuscular injection (i.m.)

• 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:
  • Type: Recombinant protein preparation
  • Description: (Nicholaou et al., 2009)
  • Detailed Gene Information: Click Here.
• Adjuvant:
  • VO ID: VO_0001333
• Immunization Route: Intramuscular injection (i.m.)

• 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
  • Detailed Gene Information: Click Here.
• Adjuvant:
  • VO 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).

• Vaccine Ontology ID: VO_0004610
• Type: Live, attenuated vaccine
• Status: Research
• IL12 gene engineering:
  • Type: Recombinant protein preparation
  • Description: (Nicholson et al., 2003)
  • Detailed Gene Information: Click Here.
• Immunization Route: Intramuscular injection (i.m.)
• Description: This trial provides preliminary evidence of a new, non-toxic, immunotherapeutic regimen in the management of malignant melanoma (Nicholson et al., 2003).

Human Response

• Vaccination Protocol: Forty-eight treatment naive patients with non-resectable, histologially confirmed adenocarcinoma of the pancreas were enrolled in the study (September 2000–March 2003). he vaccine was administered by intradermal (i.d.) injection in the right para-umbilical area following the schedule; three injections in week 1and one weekly injection in weeks 2, 3, 4, 6, and 10. The three different doses of vaccine administered were; low dose: 60 nmole (112 μg) GV1001 in 0.10 ml saline, intermediate dose: 300 nmole (560 μg) GV1001 in 0.125 ml saline, and high dose: 1.0 μmole (1.87 mg) GV1001 in 0.20 ml saline. From 5 to 15 min before each vaccine injection, 30 μg granulocyte–macrophage colony-stimulating factor in 0.10 ml saline was injected i.d. at the vaccination site (Bernhardt et al., 2006).
• Immune Response: Overall, a vaccine related immune response was detected in 63% of the evaluable study population (Bernhardt et al., 2006).
• Efficacy: Median survival for the intermediate dose-group was 8.6 months, significantly longer for the low- (P = 0.006) and high-dose groups (P = 0.05). One-year survival for the evaluable patients in the intermediate dose group was 25% (Bernhardt et al., 2006).

Human Response

• Vaccine Immune Response Type: VO_0000286
• Efficacy: Repetitive dosing of pCEA/HBsAg induced HBsAg antibodies in 6 of 8 patients, and 4 of these patients achieved protective antibody levels (>10 mIU/ml) (Conry et al., 2002).

Human Response

• Vaccine Immune Response Type: VO_0000286
• Efficacy: The fact that, at a median follow-up of 1 year, 16 of 26 patients still were alive is notable, because the median survival of patients with Stage IV melanoma in recent trials was 7–9 months from first treatment. The 11 patients who had detectable immune responses to tyrosinase 207–216 had appreciably fewer deaths and superior survival compared with the 13 patients who had no immune responses (Tagawa et al., 2003).

Human Response

• Vaccine Immune Response Type: VO_0003057
• Immune Response: Vaccination with mRNA-electroporated DC induces a broad repertoire of IFNγ producing TAA-specific CD8(+) and CD4(+) T-cell responses, particularly in stage III melanoma patients (Aarntzen et al., 2012).

Human Response

• Vaccine Immune Response Type: VO_0003057
• Immune Response: inhibition of the proliferation of B16-F10 cells invading the lungs and suppression of tumor-associated angiogenesis, downregulation of PKC, resulting in antimetastatic effects, upregulation of wild-type p53, leading to the induction of apoptosis of B16-F10, which has very low levels of endogenous p53, or antigenic epitopes in degenerating B16-F10 cells engulfed by immune-activated antigen-presenting cells could be presented to cytotoxic T lymphocytes, leading to a potent immune response against the remaining tumor cells (Fang et al., 2009).

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).

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).

Human Response

• Vaccine Immune Response Type: VO_0003057
• Immune Response: no responses were seen in the first 16 patients receiving SRL172 alone (Nicholson et al., 2003)