Vaccine adjuvants aluminum hydroxide adjuvant

Aluminum hydroxide adjuvant is used in parenteral human and veterinary vaccines. It activates Th2 immune responses, including IgG and IgE antibody responses. It is also used for the isolation of certain serum components such as blood clotting factors. ... 

Table 2 lists various types of biopharmaceutical products from animal cell cultures. Viral vaccines are usually produced by first culturing the host cells (e.g., MRC-5 and WI-38) to form a cell layer on the surface of substratum. Seed virus is then added and incubated for about 3 weeks for replication in the host cells without killing them. After washing to remove the medium components, the cells are lysed to release the virions for harvesting and purification. The inactivated viral vaccine is produced by inactivation with formaldehyde and adsorption onto aluminum hydroxide adjuvant. 

Wittayanukulluk, A. et al.. Effect of microenvuonment pH of aluminum hydroxide adjuvant on the chemical stability of adsorbed antigen, Vaccine. 22, 1172, 2004. 

Very often, vaccines are formulated with certain substances to enhance the immune response. These substances are called adjuvants (from the Latin adju-vare, which means to help ). The most common adjuvants for human use are aluminum hydroxide, aluminum phosphate, and calcium phosphate. Other adjuvants being used include bacteria and cholesterol. Mineral oil emulsions are normally the adjuvants used in animal studies. The adjuvant known as Freund s complete adjuvant consists of killed tubercle bacilli in water-inmineral oil emulsion, and Freund s incomplete adjuvant is a water-in-oil emulsion. Both these adjuvants are effective in stimulating an immune response, but they cause unacceptable side effects in humans (see Table 4.2). 

Very often whole-killed vaccines are formulated with adjuvants, which are designed to enhance vaccine persistence and induction of immune responses. However, the only adjuvant currently approved by FDA for clinical use is alum, in the form of vaccines complexed with aluminum hydroxide or aluminum sulfate. Even with the help of alum adjuvants, inactivated vaccine antigens are presented to APC extracellularly, as opposed to intracellularly, leading to a bias toward antibody-mediated responses. Little or no cell-mediated response to whole-killed vaccines with alum adjuvant renders some vaccines ineffective. 

Following intramuscular administration of aluminum hydroxide or aluminum phosphate vaccine adjuvants in rabbits, increased levels of26Al were found in the kidney, spleen, liver, heart, lymph nodes, and brain (in decreasing order of aluminum concentration) (Flarend et al. 1997). 

Aluminum, in the form of aluminum hydroxide, aluminum phosphate or aluminum potassium sulfate, is used as adjuvant in various vaccine formulations to elicit an increased immunogenic response. 

Aluminum adjuvants in human vaccines are either aluminum hydroxyphosphate (commonly referred to as aluminum phosphate) or aluminum oxyhydroxide (aluminum hydroxide). Aluminum-based vaccines are prepared by adsorption of antigen to commercial aluminum hydroxide or aluminum phosphate gels or by mixing antigen with alum (potassium aluminum sulfate),... 

The aluminum hydroxide gel referred to in the USP 28 is used in cosmetics as an emollient, filler, humectant, a mild astringent, and viscosity controlling agent. In pharmaceutical preparations it is used as an adsorbent, and as a protein binder. It is also used therapeutically as an antacid, and as an abrasive in dentrifrices. It is not, however, used as a vaccine adjuvant. 

Adjuvants such as QS21 or CpG-ODN have been described which induce a type 1 cellular immune response, whereas in contrast, aluminum hydroxide was shown to induce a type 2 immune response. Thus, it is important to choose the correct adjuvant(s) that is required to initiate a humoral and/or cellular as well as type 1 and/or type 2 immune response by vaccination. For an efficient stimulation of an immune response capable of eliminating a... 

There also is a marketed Lyme disease vaccine containing recombinant OspA (31,115,116). The vaccine is a sterile suspension of a noninfectious recombinant vaccine containing an immunodominant outer surface protein of Borrelia burgdorferi known as lipoprotein OspA. The antigen is adsorbed onto aluminum hydroxide as an adjuvant. Vaccine efficacy against definite Lyme disease is 78% after three doses. 

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