Vaccine adjuvants aluminum phosphate adjuvant

A dose of vaccine containing ILf (2-2.5 pg) tetanus toxoid in aluminum phosphate adjuvant at pH 6.0 (1 1) (TT j) or a dose of adjuvant alone in a dose corresponding to the dose given with the vaccine (ADJ) is administered intramuscularly. The administration site is the left hind leg quadriceps see Note 11). 

Aluminum phosphate adjuvant is used in parenteral human and veterinary vaccines. It activates Th2 immune responses, including IgG and IgE antibody responses. 

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). 

A wide variety of materials have been explored for their adjuvant activity, although not all are equally effective or nontoxic, especially in humans. Alum and other aluminum salts were first recognized in 1926 and remain the most effective agents licensed for human use by the FDA, although some French products also use calcium phosphate. However, in recent years it has become evident that new and improved vaccine adjuvants are needed. 

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 USP 28 monograph for aluminum phosphate (ALPO4) gel describes aluminum phosphate, which is used as an antacid, not as a vaccine adjuvant. 

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