Table 2.
List of clinical trials using whole vaccines prepared from HER2 protein, whole cell, dendritic cells and DNA (clinicaltrials.gov)
| Vaccine | Adjuvant | Additional intervention | Condition | Study population | Phase | Status | Clinicaltrials.gov identifier |
|---|---|---|---|---|---|---|---|
| HER2/neu intracellular domain protein | GM-CSF | Trastuzumab | Breast cancer | Patients with locally advanced HER2-positive (IHC 2 + or 3 +) stage IIIB–IV | II | Active, not recruiting | NCT00343109 |
| HER2/neu intracellular domain protein | Polysaccharide- K | Trastuzumab or pertuzumab | Breast cancer | Stage IV, HER2-positive, (IHC 2 + or 3 +) | I/II | Active, not recruiting | NCT01922921 |
| HER2 protein AUTOVAC (PX104.1.6) | – | – | Breast cancer | HER2-positive (IHC: 1 + , 2 + or 3 +) | I | Completed | NCT00068614 |
| Cholesterol-bearing hydrophobized pullulan HER2 protein 146 (CHP-HER2) and NY-ESO-1 protein (CHP-NY-ESO-1) | OK-432 (Picibanil) |
Esophageal cancer Lung cancer Stomach cancer Breast cancer Ovarian cancer |
HER2 (IHC 1 + or more) and/or NY-ESO-1-expressing cancers | I | Completed | NCT00291473 | |
| dHER2 (truncated version of the HER2 protein) | AS15 ASCI | Lapatinib | Metastatic breast cancer |
HER2 (IHC 3 +) Metastatic breast cancer Refractory to Trastuzumab |
I/II | Completed | NCT00952692 |
| HER2/neu intracellular domain protein | – | – | Breast cancer | Stage III or stage IV breast cancer that overexpresses HER2 | – | Completed | NCT00363012 |
| dHER2 Recombinant Protein | AS15 | Neoplasm, breast cancer |
HER2 (IHC 3 +) Metastatic breast cancer |
I/II | Completed | NCT00140738 | |
| Recombinant dHER2 protein | AS15 | Breast cancer | HER2-overexpressing Patients with high-risk breast cancer | I | Completed | NCT00058526 | |
| MVA-BN-HER2 highly attenuated non-replicating vaccinia virus, MVA-BN®, engineered to encode a modified form of the HER2 protein | Breast cancer | HER2 (IHC 3 +) after adjuvant therapy | I | Completed | NCT01152398 | ||
| MVA-BN-HER2 highly attenuated non-replicating vaccinia virus, MVA-BN®, engineered to encode a modified form of the HER2 protein | Breast cancer | Patients with metastatic HER2-positive breast cancer | I | Completed | NCT00485277 | ||
| DC1 vaccine pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) | Breast cancer | Male and female stage I–III HER2-positive | II | Recruiting | NCT03384914 | ||
| Dendritic cell vaccine (DC1) | – | (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) | Breast cancer | Patients with stage II/III HER2-positive breast cancer | Early phase I | Recruiting | NCT03387553 |
| Pembrolizumab | Trastuzumab | Breast cancer | Trastuzumab-resistant, metastatic, HER2-positive breast cancer | 1b-2 | Closed | NCT02129556 | |
| HER2 DC1 vaccine | Breast cancer | Nonmetastatic HER2-positive (IHC 3 +), previously treated with DC1 HER2-pulsed vaccine | II | Recruiting | NCT03630809 | ||
| Allogeneic breast cancer vaccine | GM-CSF | Trastuzumab, Cyclophosphamide | Breast cancer | HER2 (IHC 3 +), high risk, metastatic patients | I | Completed | NCT00847171 |
| DNA plasmid based vaccine encoding the HER2/Neu intracellular domain (pNGVL3-hICD vaccine) | GM-CSF | Breast and ovarian cancers | Patients with HER2 (IHC 2 + or 3 +) with metastatic stage III or IV breast cancer or stage III or IV ovarian cancer | I | Active, not recruiting | NCT00436254 |