Table 3.
Clinical development of plant‐produced candidate countermeasures
| Company/organization | Product type (name)a | Product detail | Target antigen/strain | Adjuvant (number of doses) | Route of administration | Participant condition | Product development status | Reference or clinical trial identifier (NCT)b |
|---|---|---|---|---|---|---|---|---|
| LeafBio | mAb (ZMapp) | Triple cocktail (13C6, 2G4, 4G7), humanized, glycoengineered | GP/Zaire | None (3) | IV | Infected | Investigational therapy (five of seven treated patients survived) | McCarthy (2014); Lyon et al. (2014) |
| LeafBio | mAb (ZMapp) | Triple cocktail (13C6, 2G4, 4G7), humanized, glycoengineered | GP/Zaire | None (not specified) | IV | Infected | Phase 1/2 (enrolling by invitation) | NCT02363322 |
| LeafBio | mAb (ZMapp) | Triple cocktail (13C6, 2G4, 4G7), humanized glycoengineered | GP/Zaire | None (1) | IV | Healthy | Phase 1 (recruiting) | NCT02389192 |
| FhCMB | SUV (PA83‐FhCMB) | Monomer | PA83 | Alhydrogel (3) | IM | Healthy | Phase 1 (recruiting) | NCT02239172 |
| FhCMB | SUV (HAC1) | Monomer | HA/H1N1 seasonal | Alhydrogel (2) | IM | Healthy | Phase 1 (completed) | NCT01177202 |
| FhCMB | SUV (HAI‐05) | Monomer | HA/H5N1 pandemic | Alhydrogel (2) | IM | Healthy | Phase 1 (completed) | NCT01250795 |
| Medicago | SUV | eVLP | HA/H1N1 seasonal | None (1) | IM | Healthy | Phase 1 (completed) | NCT01302990 |
| Medicago | SUV | eVLP | HA/H1N1, H3N2, B seasonal | None (1) | IM | Healthy | Phase 1/2 (ongoing) | NCT01991587 |
| Medicago | SUV | eVLP | HA/H1N1, H3N2, B seasonal | None (1) | IM | Healthy | Phase 2 (recruiting) | NCT02233816 |
| Medicago | SUV | eVLP | HA/H1N1, H3N2, B seasonal | Alhydrogel (1) None (1) | IM | Healthy | Phase 1 (recruiting) | NCT02236052 |
| Medicago | SUV | eVLP | HA/H5N1 pandemic | Alhydrogel (2) | IM | Healthy | Phase 1 (completed) | NCT00984945 |
| Medicago | SUV | eVLP | HA/H5N1 pandemic | Alhydrogel (2) None (2) | IM | Healthy | Phase 2 (completed) | NCT01244867 |
| Medicago | SUV | eVLP | HA/H5N1 pandemic | Alhydrogel (2) GLA‐SE (2) | IM | Healthy | Phase 2 (ongoing) | NCT01991561 |
| Medicago | SUV | eVLP | HA/H5N1 pandemic | GLA‐AF (1) | IM and ID | Healthy | Phase 1 (completed) | NCT01657929 |
| Medicago | SUV | eVLP | HA/H7N9 pandemic | Alhydrogel (2) None (2) | IM | Healthy | Phase 1 (ongoing) | NCT02022163 |
All listed plant‐based products were transiently produced in Nicotiana benthamiana plants.
Registered at https://clinicaltrials.gov.
eVLP, enveloped virus‐like particle; FhCMB, Fraunhofer USA Center for Molecular Biotechnology; GLA‐SE, glucopyranosyl lipid adjuvant in squalene emulsion; GLA‐AF, GLA aqueous nanoparticle suspension formulation; GP, recombinant glycoprotein; HA, recombinant hemagglutinin; ID, intradermal; IM, intramuscular; IV, intravenous; mAb, monoclonal antibody; PA, protective antigen; SUV, subunit vaccine.
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