Table 2.
Adjuvants in clinical development (for details see https://www.clinicaltrials.gov/).
| Adjuvant | N of clinical trials | Type | Study phase | Applications |
|---|---|---|---|---|
| Alum | 203 | 175 prophylactic | 1 Pilot, 109 Phase I, 16 Phase I/II, 31 Phase II, 4 Phase II/III, 11 Phase III, 3 Phase IV | Allergy, anthrax, botulism, candidiasis, Campylobacter, Clostridium difficile, dengue, encephalitis, Helicobacter pylori, hepatitis b, Herpes simplex, hookworm infection, human papillomavirus, influenza, leishmaniasis, malaria, Meningococcus, Norovirus, Pneumococcus, poliomyelitis, Ross River virus, SARS, schistosomiasis, shigellosis, Staphylococcus, Streptococcus, West Nile virus, yellow fever |
| 28 therapeutic | 8 Phase I, 5 Phase I/II, 13 Phase II, 2 Phase III | Cocaine dependence, colorectal cancer, diabetes, HDL, HIV, hypertension, malaria, melanoma, myasthenia gravis, nicotine dependence, prostate cancer, rhinoconjunctivitis | ||
|
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| Freund's incomplete adjuvant | 190 | 9 prophylactic | 4 Phase I, 1 Phase I/II, 2 Phase II, 2 Phase III | Bladder cancer, carcinoma, influenza, malaria, melanoma |
| 181 therapeutic | 3 Pilot, 63 Phase I, 41 Phase I/II, 64 Phase II, 2 Phase II/III, 8 Phase III | Acute myeloid leukemia, adenocarcinoma, bladder cancer, bile duct cancer, brain cancer, breast cancer, carcinoma, chronic myeloid leukemia, colorectal cancer, esophageal cancer, gastric cancer, glioblastoma, HIV, HPV-induced cancer, kidney cancer, liver cancer, melanoma, multiple myeloma, multiple sclerosis, non-small-cell lung cancer, ovarian cancer, pancreatic cancer, prostate cancer, renal cell cancer | ||
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| MF59 | 93 | 92 prophylactic | 27 Phase I, 6 Phase I/II, 34 Phase II, 3 Phase II/III, 16 Phase III, 6 Phase IV | Cytomegalovirus infections, influenza, HIV, respiratory syncytial virus |
| 1 therapeutic | 1 Phase I | HIV | ||
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| Virosomes | 23 | 23 prophylactic | 8 Phase I, 1 Phase I/II, 1 Phase II, 9 Phase III, 4 Phase IV | Hepatitis A, Hepatitis C, influenza, malaria, vulvovaginal candidiasis |
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| Virus-like particles | 101 | 95 prophylactic | 19 Phase I, 6 Phase I/II, 31 Phase II, 36 Phase III, 3 Phase IV | Chikungunya, Enterovirus 71, HIV, human papillomavirus, influenza, malaria, Norovirus |
| 6 therapeutic | 2 Phase I, 1 Phase I/II, 3 Phase II | Hypertension, melanoma, respiratory syncytial virus | ||
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| Poly(I:C) | 16 | 1 prophylactic | 1 Phase I/II | Influenza |
| 15 therapeutic | 2 Pilot, 5 Phase I, 7 Phase I/II, 1 Phase II | Acute myeloid leukemia, allergy, breast cancer, glioblastoma, lymphoma, melanoma, non-small-cell lung cancer, ovarian cancer, prostate cancer | ||
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| Poly-IC:LC | 56 | 3 prophylactic | 2 Phase I, 1 Phase II | Colorectal cancer, HIV, melanoma |
| 53 therapeutic | 6 Pilot, 19 Phase I, 17 Phase I/II, 11 Phase II | Acute myeloid leukemia, astrocytoma, bladder cancer, breast cancer, colorectal cancer, epithelial ovarian cancer, glioblastoma, glioma, HIV, low grade B cell lymphoma, melanoma, myeloma, non-small-cell lung cancer, pancreatic adenocarcinoma, prostate cancer | ||
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| Monophosphoryl lipid A | 31 | 22 prophylactic | 7 Phase I, 2 Phase I/II, 6 Phase II, 7 Phase III | Hepatitis B, Herpes simplex, HIV, hookworm infections, malaria, Norovirus, visceral leishmaniasis |
| 9 therapeutic | 2 Phase I, 1 Phase I/II, 5 Phase II, 1 Phase III | Allergic rhinitis, cutaneous leishmaniasis, melanoma, type I hypersensitivity | ||
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| Flagellin | 6 | 6 prophylactic | 4 Phase I, 1 Phase I/II, 1 Phase II | Diarrhea, influenza, plague |
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| Imiquimod | 40 | 3 prophylactic | 1 Phase II, 1 Phase II/III, 1 Phase III | Influenza, Hepatitis B, Varicella zoster |
| 37 therapeutic | 2 Pilot, 20 Phase I, 2 Phase I/II, 9 Phase II, 2 Phase III, 2 Phase IV | Adenocarcinoma of the prostate, basal cell carcinoma, brain tumor, breast cancer, cervical cancer, ependymoma, gastric cancer, glioblastoma, glioma, human papillomavirus, melanoma, non-small-cell lung cancer, ovarian cancer, prostate cancer, sarcoma | ||
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| Resiquimod | 11 | 3 prophylactic | 2 Phase I, 1 Phase I/II | Allergic rhinitis, Hepatitis B, influenza |
| 8 therapeutic | 2 Pilot, 1 Phase I, 2 Phase I/II, 3 Phase II | Advanced malignances, bladder cancer, glioma, melanoma | ||
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| CpG ODN | 9 | 6 prophylactic | 3 Phase I, 3 Phase I/II | Bacterial sepsis, HIV, hookworm infection, malaria |
| 3 therapeutic | 1 Phase I, 1 Phase I/II, 1 Phase II | Allergic rhinitis, breast cancer, Hepatitis B, HIV | ||
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| Muramyl dipeptide | 1 | 1 prophylactic | 1 Phase I | HIV |
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| AS03 | 22 | 22 prophylactic | 5 Phase I, 3 Phase I/II, 11 Phase II, 1 Phase III, 2 Phase IV | Dengue, influenza |
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| AS04 | 38 | 37 prophylactic | 2 Phase I, 6 Phase II, 27 Phase III, 2 Phase IV | Cervical cancer, Herpes simplex, human papillomavirus |
| 1 therapeutic | 1 Phase II/III | Hepatitis B | ||