Table 1.
Mucosal adjuvants in human clinical trials. Vaccine clinical trials registered on clinicaltrials.gov were searched for compounds categorized as adjuvants and delivered to mucosal surfaces.
| Compound | Antigen | Phase | Results | Investigators | Ref | Trial Id |
|---|---|---|---|---|---|---|
| Type 1 IFN | Influenza, 2006–2007 trivalent inactivated vaccine | 1 | No effect | NIAID, Baylor College of Medicine | [113] | NCT00436046 |
| E.coli LT | Influenza, virosome/subunit | n/a vaccine used in Switzerland in 2000–2001 | Effective, but strong association with Bell’s Palsy | Berna Biotech | [114] | |
| polyICLC (Hiltonol) | Respiratory viral infections, including influeza | 1 | NIAID | NCT00646152 | ||
| polyI:polyC12U (Ampligen) | Influenza, FluMist | I/II Canceled due to withdrawal of FluMist in 2016 |
Specific SIgA titers >4x over baseline. Well tolerated | Hemispherx Biopharma Inc. | [115] | NCT01591473 |
|
Oleic acid, mono-olein (Endocine™) |
Influenza A/California/07/2009 H1N1 | I | Eurocine Vaccines Ab | NCT02998996 | ||
|
Oleic acid, mono-olein (Endocine™) |
HIV Vacc-4x p24 consensus peptides | I | Safe, antigenic dose-dependent immune responses | Eurocine Vaccines Ab | [116] | NCT01473810 |
| Cholera toxin B subunit | None | NCT00820144 | ||||
| Aluminum hydroxide | Streptococcus pneumoniae GEN-004 | I | Non-significant reduction in carriage rate | Genocea Biosciences | NCT02116998 | |
| Rintatolimod | FluMist | I/II | Well tolerated. 92% of vaccinees produced specific sIgA. | Hemispherx Biopharma Inc. |
NCT01591473 (terminated as nasal flu spray not CDC recommended 2016–2017) |
|
| Proteasome (N. meningitides OMP) | Trivalent Influenza HA | ID Biomedical, Quebec | [117] | NCT025227541 |