Table 1.
Clinical studies of plant-derived vaccines (data from US National Institutes of Health clinical trial).
| Application | Study | Status | Sponsor |
|---|---|---|---|
| Anthrax (1) | A Phase I Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults | Phase I (2015), ongoing (NCT02239172) | Fraunhofer, Center for Molecular Biotechnology |
| Influenza, Human (3) | Safety and Immunogenicity of a Recombinant H5N1 Vaccine in Adults | Unknown (2011), (NCT01250795) | Fraunhofer, Center for Molecular Biotechnology |
| Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults | Phase II (2015), ongoing (NCT02233816) | Medicago | |
| Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal VLP Quadrivalent Influenza Vaccine in the Elderly Population | Phase II (2015), ongoing (NCT02236052) | Medicago | |
| Malaria | Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults | Phase I (2015), ongoing (NCT02013687) | Fraunhofer, Center for Molecular Biotechnology |
| Gaucher Disease | A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease | Phases III, completed (2012) (NCT00376168) | Protalix |
| Ebola Virus | Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection | Phase I,II, recruiting (2015) (NCT02363322) | Zmapp, National Institute of Allergy and Infectious Diseases (NIAID) |
| Fabry disease | An Extension of a Phase I/II, Open Label, Dose Ranging Study of PRX-102 in Adult Fabry Patients | Phase I,II, enrolling (2015) (NCT01769001) | Protalix |
| Human Immunodeficiency Virus | A Safety Study Of A Single Vaginal Administration of P2G12 Antibody In Healthy Female Subjects | Phase I, completed (NCT01403792) | University of Surrey (European Commission) |
| Influenza A Subtype H5N1 Infection | H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers | Phase I, completed (NCT01657929) | Infectious Disease Research Institute (IDRI), Medicago |
| Vitamin B12 Deficiency | Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? | Phase II, completed (NCT00279552) | University of Aarhus |
| Healthy | Safety and Immunogenicity of a Recombinant H5N1 Vaccine in Adults | Phase I, unknown (NCT01250795) | Fraunhofer, Center for Molecular Biotechnology |