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EDIBLE VACCINES: CURRENT STATUS and FUTURE P Lal, VG Ramachandran, *R Goyal, R Sharma Abstract

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EDIBLE VACCINES: CURRENT STATUS and FUTURE P Lal, VG Ramachandran, *R Goyal, R Sharma Abstract IndianApril-June Journal 2007 of Medical Microbiology, (2007) 25 (2):93-102 93 Review Article EDIBLE VACCINES: CURRENT STATUS AND FUTURE P Lal, VG Ramachandran, *R Goyal, R Sharma Abstract Edible vaccines hold great promise as a cost-effective, easy-to-administer, easy-to-store, fail-safe and socioculturally readily acceptable vaccine delivery system, especially for the poor developing countries. It involves introduction of selected desired genes into plants and then inducing these altered plants to manufacture the encoded proteins. Introduced as a concept about a decade ago, it has become a reality today. A variety of delivery systems have been developed. Initially thought to be useful only for preventing infectious diseases, it has also found application in prevention of autoimmune diseases, birth control, cancer therapy, etc. Edible vaccines are currently being developed for a number of human and animal diseases. There is growing acceptance of transgenic crops in both industrial and developing countries. Resistance to genetically modiÞ ed foods may affect the future of edible vaccines. They have passed the major hurdles in the path of an emerging vaccine technology. Various technical obstacles, regulatory and non-scientiÞ c challenges, though all seem surmountable, need to be overcome. This review attempts to discuss the current status and future of this new preventive modality. Key words: Chimeric, edible vaccines, transgenic Vaccines have been revolutionary for the prevention of desired genes into plants and then inducing these altered infectious diseases. Despite worldwide immunization of plants to manufacture the encoded proteins. This process is children against the six devastating diseases, 20% of infants known as “transformation,” and the altered plants are called are still left un-immunized; responsible for approximately “transgenic plants.” Like conventional subunit vaccines, two million unnecessary deaths every year, especially in the edible vaccines are composed of antigenic proteins and remote and impoverished parts of the globe.1 This is because are devoid of pathogenic genes. Thus, they have no way of the constraints on vaccine production, distribution and of establishing infection, assuring its safety, especially in delivery. One hundred percent coverage is desirable, because immunocompromised patients. Conventional subunit vaccines un-immunized populations in remote areas can spread are expensive and technology-intensive, need puriÞ cation, infections and epidemics in the immunized “safe” areas, require refrigeration and produce poor mucosal response. which have comparatively low herd immunity. For some In contrast, edible vaccines would enhance compliance, infectious diseases, immunizations either do not exist or they especially in children, and because of oral administration, are unreliable or very expensive. Immunization through DNA would eliminate the need for trained medical personnel. Their vaccines is an alternative but is an expensive approach, with production is highly efÞ cient and can be easily scaled up. disappointing immune response.2 Hence the search is on for For example, hepatitis-B antigen required to vaccinate whole cost-effective, easy-to-administer, easy-to-store,(www.medknow.com). fail-safe of China annually, could be grown on a 40-acre plot and all and socioculturally readily acceptable vaccines and their babies in the world each year on just 200 acres of land!4 They delivery systems. As Hippocrates said, “Let thy food be thy are cheaper, sidestepping demands for puriÞ cation (single dose medicine,” scientists suggest that plants and plant viruses can of hepatitis-B vaccine would cost approximately 23 paise), be genetically engineeredThis to produce PDFa site vaccines is hosted available against diseases by for Medknowgrown free locally download usingPublications standard from methods and do not require such as dental caries; and life-threatening infections like capital-intensive pharmaceutical manufacturing facilities. diarrhea, AIDS, etc.3 This is the concept of edible vaccines. Mass-indeÞ nite production would also decrease dependence The following discussion will address issues relating to on foreign supply. They exhibit good genetic stability. They their commercial development, especially their usefulness in are heat-stable; do not require cold-chain maintenance; can preventing infectious diseases in developing countries. be stored near the site of use, eliminating long-distance transportation. Non-requirement of syringes and needles also Concept of Edible Vaccines decreases chances of infection.5 Fear of contamination with Creating edible vaccines involves introduction of selected animal viruses - like the mad cow disease, which is a threat in vaccines manufactured from cultured mammalian cells - is *Corresponding author (email: <[email protected]>) eliminated, because plant viruses do not infect humans. Departments of Microbiology (PL, VGR, RG) and Pediatrics (RS), University College of Medical Sciences, Guru Teg Bahadur Hospital, Edible vaccines activate both mucosal and systemic New Delhi - 110 095, India. immunity, as they come in contact with the digestive tract Received : 28-06-06 lining. This dual effect would provide Þ rst-line defense against Accepted : 14-10-06 pathogens invading through mucosa, like Mycobacterium www.ijmm.org 93 CMYK 94 Indian Journal of Medical Microbiology vol. 25, No. 2 tuberculosis and agents causing diarrhea, pneumonia, STDs, dependent and takes 3-9 months. Reducing this time to 6-8 HIV, etc. Scientists place high priority on combating the weeks is currently under investigation. Some antigens, like diarrheal agents – Norwalk virus, Rotavirus, Vibrio cholerae viral capsid proteins, have to self-assemble into VLPs (virus- and enterotoxigenic E. coli (ETEC) – responsible for about like particles). VLPs mimic the virus without carrying DNA three million infant deaths/year, mainly in developing or RNA and therefore are not infectious. Each single antigen countries.1 Administration of edible vaccines to mothers expressed in plants must be tested for its proper assembly and might be successful in immunizing the fetus-in-utero by can be veriÞ ed by animal studies, Western blot; and quantiÞ ed transplacental transfer of maternal antibodies or the infant by enzyme-linked immunosorbent assay (ELISA).11 through breast milk. Edible vaccines seroconvert even in the presence of maternal antibodies, thus having a potential role in “Second-Generation” Edible Vaccines protecting infants against diseases like group-B Streptococcus, Successful expression of foreign genes in plant cells and/or respiratory syncytial virus (RSV), etc., which are under its edible portions has given a potential to explore further and 6 investigation. Edible vaccines would also be suitable against expand the possibility of developing plants expressing more neglected/rare diseases like dengue, hookworm, rabies, etc. than one antigenic protein. Multicomponent vaccines can They may be integrated with other vaccine approaches, and be obtained by crossing two plant lines harboring different multiple antigens may also be delivered. Various foods under antigens. Adjuvants may also be co-expressed along with the study are banana, potato, tomato, lettuce, rice, etc. Edible antigen in the same plant. B subunit of Vibrio cholerae toxin vaccines are currently being developed for a number of human (VC-B) tends to associate with copies of itself, forming a and animal diseases, including measles, cholera, foot and doughnut-shaped Þ ve-member ring with a hole in the middle.1 7 mouth disease and hepatitis B, C and E. This feature can bring several different antigens to M cells at one time - for example, a trivalent edible vaccine against Mechanism of Action cholera, ETEC (Enterotoxigenic E. coli) and rotavirus could The antigens in transgenic plants are delivered through successfully elicit signiÞ cant immune response to all three.12 bio-encapsulation, i.e., the tough outer wall of plant cells, Global alliance for vaccines and immunization (GAVI) which protects them from gastric secretions, and finally accords very high priority to such combination vaccines for break up in the intestines. The antigens are released, taken developing countries. up by M cells in the intestinal lining that overlie peyer’s Various Strategies patches and gut-associated lymphoid tissue (GALT), passed on to macrophages, other antigen-presenting cells; and local Approaches to mucosal vaccine formulation include (i) lymphocyte populations, generating serum IgG, IgE responses, gene fusion technology, creating non-toxic derivatives of local IgA response and memory cells, which would promptly mucosal adjuvants; (ii) genetically inactivating antigens by neutralize the attack by the real infectious agent.8 deleting an essential gene; (iii) co-expression of antigen and a cytokine, which modulates and controls mucosal immune Preparation of Edible Vaccines response; and (iv) genetic material itself, which allows DNA/ Introduction of foreign DNA into plant’s genome can either RNA uptake and its endogenous expression in the host cell. be done by bombarding embryonic suspension cell(www.medknow.com). cultures Various mucosal delivery systems include biodegradable using gene-gun or more commonly through Agrobacterium micro- and nanoparticles, liposomes, live bacterial/viral 13 tumefaciens, a naturally occurring soil bacterium, which has vectors and mucosal adjuvants. “Prime-boost” strategy the ability to get into plants through
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