Respiratory syncytial virus (RSV)-caused disease represents a significant health care burden worldwide. The RSV infects virtually all children throughout the world in both developed and developing countries. Re-infection is common because natural infection does not induce lasting immunity. Also, severe RSV infections are increasingly occurring among the elderly. In spite of wide-scale efforts to produce an effective vaccine against RSV, no vaccine is yet available. Development of an inexpensive edible plant-based oral vaccine is an innovative approach for the control of RSV. The present study extends the strategy of using a plant-based oral vaccine to a respiratory pathogen for the first time. Even if lasting immunity is not obtained with the plant-based vaccine, it would be relatively low in cost to use such a vaccine during successive RSV seasons. We have shown previously that oral immunization of mice with transgenic tomato fruit expressing an RSV- subunit protein, i.e., the F-protein, induces a systemic immune response. This "proof of principle" Phase I study will optimize the expression of the RSV-F protein in the transgenic tomato fruit and determine the capacity of this orally-given antigenic protein to protect against an RSV challenge in two commonly-used models for RSV studies, the Balb/c mouse and the cotton rat. Success will validate the further development of our tomato- based vaccine against RSV and set the stage for a Phase II study. Such a vaccine will definitely make a difference and have an enduring impact on human health.
Public Health Relevance: Respiratory syncytial virus-caused disease is a significant health care burden worldwide, but no vaccine is available. We are developing an inexpensive vaccine using tomato plants to control this virus.
Thesaurus Terms: 0-11 Years Old; Atgn; Affect; Aged 65 And Over; Animals; Antibodies; Antigens; Attenuated; Balb/C; Bacteria; Blood Serum; Capsid Proteins; Care, Health; Cell Culture Techniques; Characteristics; Child; Child Youth; Children (0-21); Coat Proteins; Cotton Rats; Developing Countries; Developing Nations; Development; Diet; Disease; Disorder; Dose; E Coli; Edible Plants; Elderly; Elderly, Over 65; Enterotoxins; Escherichia Coli; F Protein, Respiratory Syncytial Virus; Food; Food Plants; Fruit; Goals; Health; Healthcare; Heating; Hepatitis B; Hepatitis B Infection; Human; Human Volunteers; Human, Child; Human, General; Immune Tolerance; Immune Response; Immunity; Immunization; Immunologic Stimulation; Immunologic Tolerance; Immunological Stimulation; Immunostimulation; Inbred Balb C Mice; Infection; Injection Of Therapeutic Agent; Injections; Insecta; Insects; Invertebrates, Insects; Killings; Lead; Less-Developed Countries; Less-Developed Nations; Lettuce; Lettuce - Dietary; Life; Mammalian Cell; Mammals, Mice; Man (Taxonomy); Man, Modern; Mice; Mice, Inbred Balb C; Modeling; Mouse, Balb C; Mucosa; Mucosal Tissue; Mucous Membrane; Murine; Mus; Nv Capsid; Norwalk Virus Capsid; Oral; Organism; Oropharyngeal; Oropharynx; Oropharynxs; Pb Element; Phytophagineae; Plant Viruses; Plants; Plants, Edible; Plants, General; Potato; Prp Proteins; Prion Proteins; Prions; Protein Subunits; Proteins; Rsv F Proteins, Respiratory Syncytial Virus; Refrigeration; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus; Respiratory Syncytial Virus Rsv F Proteins; Rodent Model; Safety; Seasons; Sensitization, Immunologic; Sensitization, Immunological; Serum; Staging; Subunit Vaccines; System; System, Loinc Axis 4; Testing; Third-World Countries; Third-World Nations; Time; Tomatoes; Toxin; Transgenic Animals; Transgenic Organisms; Transgenic Plants; Under-Developed Countries; Under-Developed Nations; Vaccine Production; Vaccines; Viral Coat Proteins; Viral Diseases; Viral Hepatitis B; Viral Outer Coat Protein; Virus; Virus Diseases; Viruses, General; Yeasts; Advanced Age; Base; Capsid Protein, Chitta Virus; Care Burden; Children; Cost; Dietary Fruit; Disease/Disorder; Elders; Feeding; Gastrointestinal; Gene Product; Geriatric; Heavy Metal Pb; Heavy Metal Lead; Host Response; Immune System Tolerance; Immune Unresponsiveness; Immunogen; Immunogenic; Immunological Paralysis; Immunoresponse; Innovate; Innovation; Innovative; Large Scale Production; Late Life; Later Life; Living System; Older Adult; Older Person; Oral Pharyngeal; Oral Vaccine; Pathogen; Phase 1 Study; Phase 2 Study; Protein Expression; Public Health Relevance; Respiratory; Scale Up; Senior Citizen; Serum Hepatitis; Success; Transgenic; Viral Infection; Virus Infection; Volunteer; Youngster
