Vaccine 1996 Dec;14(17-18):1703-6
Immune responses following cocktails of inactivated measles vaccine and Arachis hypogaea L. (ground nut) or Cocos nucifera L. (coconut) oils adjuvant. Eghafona NO. "The study suggests that the oils under investigation, particularly to GO (ground nut) oil should be considered as an adjuvant with IMV (Inactivated Measles Vaccine) after extensive study in humans; since it stimulated cellular immune response comparable to that of LMV (Live Measles Vaccine).
PMID 9032902
http://www.vran.org/vaccines/anaphylaxis/vaccine-ana.htm
GlaxoSmithKline
INFANRIX® Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed March 2008 - Each 0.5-mL dose also contains 4.5 mg of NaCl, and aluminum adjuvant (not more than 0.625 mg aluminum by assay).
PEDIARIX® - Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and inactivated Poliovirus Vaccine June 2007 - Each 0.5-mL dose also contains 4.5 mg of NaCl and aluminum adjuvant (not more than 0.85 mg aluminum by assay). Merck & Co M-M-Vax Measles and Mumps Virus Vaccine, Live September 2002 M-M-Vax Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin.
http://us.gsk.com/products/assets/us_infanrix.pdf
Liquid PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] Haemophilus influenzae type b and Neisseria meningitidis serogroup B are grown in complex fermentation media. [Peanut meal is often used in fermentation media....-bfg] The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. The OMPC from Neisseria meningitidis is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. Liquid PedvaxHIB is ready to use and does not require a diluent. Each 0.5 mL dose of Liquid PedvaxHIB is a sterile product formulated to contain: 7.5 mcg of Haemophilus b PRP, 125 mcg of Neisseria meningitidis OMPC and 225 mcg of aluminum as amorphous aluminum hydroxyphosphate sulfate (previously referred to as aluminum hydroxide), in 0.9% sodium chloride, but does not contain lactose or thimerosal. Liquid PedvaxHIB is a slightly opaque white suspension.
http://www.merck.com/product/usa/pi_circulars/p/pedvax_hib/pedvax_pi.pdf
Vaccine development has been advancing over the years. New types of vaccines, such as DNA-based, recombinant subunits, recombinant viruses, and conjugates have been developed and introduced commercially. These vaccines tend to be safer and less reactogenic than older-style vaccines made from live or killed whole organisms. Use of new adjuvants that work with these vaccine types and that are less reactogenic has not kept pace with vaccine technology. Part of the barrier is the stringent regulatory environment. The hurdles in the U.S. and in Europe to gain approval are high (see, for example, Guideline on Adjuvants in Vaccines for Human Use by The European Medicines Agency). In nearly 80 years since the first vaccine adjuvant was approved by the FDA (United States Food and Drug Administration), no other adjuvant has been approved by the FDA for use in humans. The FDA only approves adjuvants in combination with vaccines and does not approve adjuvants alone. Nevertheless, substantial investment in adjuvant technology continues as evidenced by patent application filings and by clinical studies.
Aluminium salts were the first adjuvants approved by the FDA for use in humans. Use of alum salts began in the 1930s, before regulatory guidelines became more stringent. More recently, approvals have been obtained in Europe for MF59 as an adjuvant component of flu vaccine for elderly patients (Fluad(r) , Novartis Vaccines) and AS04 (combination of alum and MPL, GlaxoSmithKline) as the adjuvant for a viral vaccines (hepatitis B, HPV).
http://www.patentlens.net/daisy/adjuvants/Background/Adjuvant_types.html
Water-in-oil adjuvant composition - Patent 4069313
3149036, Adjuvant vaccine with aluminum monostearate, mannide monooleate, vegetable oil, and an aqueous phase immunolgical agent, September, 1964 ...
www.freepatentsonline.com/4069313.html - Similar pages by AF Woodhour - 1978
(Coulter et al., 1998, Vaccine 16, pp. .... administered in one conventional dose of vaccine and aluminum as an adjuvant is added, ...
www.pharmcast.com/Patents/Yr2002/April2002/041602/6372223_Influenza041602.htm - 43k - Cached - Similar pages by O Kistner -
[0002] The present invention is generally in the area of controlled delivery of antigens for use in vaccination or induction of tolerance to allergens, and in particular relates to cellular delivery of proteins and polypeptides.
[0006] Current treatments for allergies involve attempts to “vaccinate” a sensitive individual against a particular allergen by periodically injecting or treating the individual with a crude suspension of the raw allergen. The goal, through controlled administration of known amounts of antigen, is to modulate the IgE response mounted in the individual. If the therapy is successful, the individual's IgE response is diminished, or can even disappear. However, the therapy requires several rounds of vaccination, over an extended time period (3-5 years), and very often does not produce the desired results. Moreover, certain individuals suffer anaphylactic reactions to the vaccines, despite their intentional, controlled administration.
[0077] Adjuvants that are known to stimulate Th2 responses are preferably avoided.
[0086] Injectable preparations, for example, sterile injectable aqueous or oleaginous suspensions may be formulated according to the known art using suitable dispersing or wetting agents and suspending agents. The sterile injectable preparation may also be a sterile injectable solution, suspension or emulsion in a nontoxic parenterally acceptable diluent or solvent, for example, as a solution in 1,3-butanediol. Among the acceptable vehicles and solvents that may be employed are water, Ringer's solution, U.S.P. and isotonic sodium chloride solution. In addition, sterile, fixed oils are conventionally employed as a solvent or suspending medium. For this purpose any bland fixed oil can be employed including synthetic mono- or diglycerides. In addition, fatty acids such as oleic acid are used in the preparation of injectables.
http://www.freepatentsonline.com/y2003/0035810.html
Vaccine Composition Comprising Alpha-Galactosylceramide as an ...
A vaccine adjuvant comprising alpha-galactosylceramide for the ... by oil emulsion (Freund's adjuvant), saponin, aluminum or calcium salts (alum), ...
www.faqs.org/patents/app/20080317769 - 86k - Cached - Similar pages
Vaccine 1992;10(10):714-20 Parameters affecting the immunogenicity of microencapsulated tetanus toxoid states “As expected, incomplete Freund’s adjuvant (IFA) proved to be a more potent adjuvant than peanut oil…………….” PMID 1523381
Can J Comp Med 1985 Apr;49(2):149-51 compared 6 different adjuvants in swine including four mineral oil compounds, one peanut oil compound and aluminum hydroxide. PMID 4016580
C R Acad Sci Hebd Seances Acad Sci D 1975 Apr 7;280(13):1629-32 states…….. a stable water in oil emulsion can be produced by using metabolizable peanut oil with arlacel. When mycobacteria are added, a potent emulsified oil adjuvant is obtained which increases the immune response to BSA and to influenza vaccine. PMID 811378
http://www.vaccinetruth.org/peanut_oil.htm
Gupta RK, Siber GR. Massachusetts Public Health Biologic Laboratories, State Laboratory Institute, Boston 02130, USA.
Adjuvants help antigen to elicit an early, high and long-lasting immune response with less antigen, thus saving on vaccine production costs. In recent years, adjuvants received much attention because of the development of purified, subunit and synthetic vaccines which are poor immunogens and require adjuvants to evoke the immune response. With the use of adjuvants immune response can be selectively modulated to major histocompatibility complex (MHC) class I or MHC class II and Th1 or Th2 type, which is very important for protection against diseases caused by intracellular pathogens such as viruses, parasites and bacteria (Mycobacterium). A number of problems are encountered in the development and use of adjuvants for human vaccines.
The biggest issue with the use of adjuvants for human vaccines, particularly routine childhood vaccines, is the toxicity and adverse side-effects of most of the adjuvant formulations. At present the choice of adjuvants for human vaccination reflects a compromise between a requirement for adjuvanticity and an acceptable low level of side-effects. Other problems with the development of adjuvants include restricted adjuvanticity of certain formulations to a few antigens, use of aluminum adjuvants as reference adjuvant preparations under suboptimal conditions, non-availability of reliable animal models, use of non-standard assays and biological differences between animal models and humans leading to the failure of promising formulations to show adjuvanticity in clinical trials.
The most common adjuvants for human use today are still aluminum hydroxide and aluminum phosphate, although calcium phosphate and oil emulsions also have some use in human vaccinations. During the last 15 years much progress has been made on development, isolation and chemical synthesis of alternative adjuvants such as derivatives of muramyl dipeptide, monophosphoryl lipid A, liposomes, QS21, MF-59 and immunostimulating complexes (ISCOMS). Other areas in adjuvant research which have received much attention are the controlled release of vaccine antigens using biodegradable polymer microspheres and reciprocal enhanced immunogenicity of protein-polysaccharide conjugates. Biodegradable polymer microspheres are being evaluated for targeting antigens on mucosal surfaces and for controlled release of vaccines with an aim to reduce the number of doses required for primary immunization. Reciprocal enhanced immunogenicity of protein-polysaccharide conjugates will be useful for the development of combination vaccines.
Publication Types: Review Review, Tutorial PMID: 8585280 [PubMed - indexed for MEDLINE]
Added 5/3/2015: The FDA does not require ingredients that comprise less than 1 percent of a product to be divulged on the label, so a lot more products may have thimerosal and consumers will never know. [Food protein traces would be less than 1%.... - bfg]