Table 2.
Summary of vaccines used in clinical trials.
| Trial name (ClinicalTrials.gov Identifier) | Treatment | Phase of trial | Number of participants | Primary end point or outcomes | Summary of results |
|---|---|---|---|---|---|
| NCT00458601 | EGFRvIII peptide vaccine + TMZ | II | 82 | PFS | Median overall survival of 21.8 months and 36-month survival of 26%. Anti-EGFRvIII antibodies increased ≥4-fold in 85% of patients with duration of treatment |
| NCT01480479 | EGFRvIII peptide vaccine + TMZ | III | 745 | OS | Strong humoral responses; however, no survival advantage and loss of EGFRvIII expression upon recurrence |
| NCT00643097 | EGFRvIII peptide vaccine + DI-TMZ | II | 40 | PFS and hypersensitivity to peptide on the basis of a positive skin test of ≥5mm in diameter | EGFRvIII-expressing cells eradicated and vaccine immunogenic, with DI-TMZ cohort having enhanced humoral response. Median overall survival of 23.6 months |
| NCT00639639 | CMV pp65 DC vaccine + DI-TMZ | I | 16 | Safety and Feasibility | Antigen-specific immune responses and median overall survival of 41.1 months in DI-TMZ cohort. A total of 36% survival 5 years from diagnosis, with four patients remaining progression-free at 59–64 months from diagnosis |
| NCT00045968 | DCVax-L vaccine | III | 348 | PFS | Median overall survival of 23.1 months, with large group (n = 100) reaching 40.5 months |
| NCT02366728 | CMV pp65 DC vaccine +111In-labeled DC vaccine + Td Toxoid + basiliximab | II | 100 | OS | Ongoing, have reported increased DC migration to lymph nodes following Td toxoid pre-conditioning |
| NCT00905060 | HSPPC-96 vaccine + TMZ | II | 46 | Safety profile and survival durations | Median overall survival of 23.8 months. Patients with low PD-L1 expression in myeloid cells had median overall survival of 44.7 months compared to 18 months for those with high expression |
| NCT01280552 | ICT-107 (autologous DC vaccine pulsed with synthetic peptides mimicking GAAs) | II | 124 | OS | Pts in the HLA-A2 subgroup showed increased ICT-107 activity immunologically with a tendency for improved clinical outcome |
| NCT00293423 | HSPPC-96 peptide vaccine | II | 41 | Safety, toxicity, and PFS | Specific immune response in 11 of the 12 patients, responders had median overall survival of 11.8 months |
| NCT02122822 | HSPPC-96 peptide vaccine + TMZ + radiotherapy | I | 20 | Immune response and cardiac effects | Median overall survival of 31.4 months. Patients with high tumor-specific immune responses had median overall survival of >40.5 months compared to 14.6 months for low responders |
| NCT02454634 | IDH1 peptide vaccine | I | 39 | Safety and immunogenicity | A total of 93% vaccine-specific response rate, 84% survival >3 years |
| NCT01498328 | EGFRvIII peptide vaccine + bevacizumab | II | 127 | PFS | 24-month survival of 20% compared to 3% for controls |
| NCT03018288 | pembrolizumab ± HSPPC-96 vaccine | II | 108 | 1-year OS | Ongoing study, estimated completion 01/2025 |
| NCT02149225 | APVAC1 and APVAC2 (personalized peptide vaccine) plus poly-ICLC and GM-CSF | I | 16 | Safety and immunogenicity | Able to generate a strong and lasting immune response |
| NCT02924038 | IMA-950 (peptide vaccine comprising multiple GAAs) and poly-ICLC ± varlilumab (immunostimulatory antiCD27 antibody) | I | 30 | Safety and T cell responses | Ongoing study, estimated completion 12/2022 |
| NCT02287428 | Personalized neoantigen vaccine | I | 16 | Safety and feasibility | Neoantigen selection is feasible and induces immune response |
| NCT02960230 | H3.3K27 M peptide vaccine plus Td and poly-ICLC | I | 29 | Safety and OS | Ongoing study, estimated completion 01/2023 |
| NCT03400917 | AV-GBM-1 (Autologous dendritic cells loaded with tumor associated antigens from a short-term cell culture of autologous tumor cells) | II | 55 | OS | Ongoing study, estimated completion 02/2023 |
| NCT02507583 | IGF-1 R/AS ODN | I | 33 | Safety and tolerability | Well tolerated with an improved PFS compared with standard-of-care |
| NCT02455557 | Montanide ISA 51 VG peptide vaccine + temozolomide | II | 66 | PFS | Improved PFS and OS |
| NCT04116658 | EO2401 peptide vaccine | II | 52 | Safety and tolerability | Ongoing study, estimated completion 8/2023 |
| NCT02465268 | pp65-shLAMP DC dendritic cell vaccine with GM-CSF | II | 175 | OS | Ongoing study, estimated completion 6/2024 |
| NCT00846456 | Tumor stem cell derived mRNA- transfected dendritic cells | I/II | 20 | Adverse events | Progression-free survival (PFS) was 2.9 times longer in vaccinated patients |
| NCT01006044 | Tumor lysate-pulsed autologous dendritic cell vaccine | II | 26 | PFS | Feasible and safe |
| Not Available | Personalized peptide vaccination for human leukocyte antigen (HLA)-A24+ | III | 88 | OS | Met neither the primary nor secondary endpoints |