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Diphtheria toxoid adsorbed on aluminium hydroxide, hydrated is a vaccine component derived from the toxin produced by the bacterium Corynebacterium diphtheriae. The toxin is chemically inactivated to make it safe while still able to stimulate an immune response. In the registry data, the full substance name is Diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, and it is one part of several authorised combination vaccines.[1]
The substance appears in product records under trade names including Infanrix hexa and Tetravac.
Diphtheria toxoid works by presenting an inactivated form of the diphtheria toxin to the immune system. The body recognises it as foreign and produces antibodies against it without causing disease. The aluminium hydroxide acts as an adjuvant, a substance that enhances the immune response to the toxoid. This priming means that if a vaccinated person later encounters the real diphtheria bacterium, their immune system can respond quickly.[6]
In combination vaccines, the diphtheria toxoid is given alongside other vaccine components such as tetanus toxoid, pertussis antigens, inactivated poliovirus, hepatitis B surface antigen, and Haemophilus influenzae type b polysaccharide. Each component targets a different pathogen, allowing protection against several diseases with a single injection.[7]
The substance is formulated as a suspension for injection and is given by intramuscular injection, meaning into a muscle.[1] In the product records, the route is listed as intramuscular use or intramuscular injection. The substance is part of fixed combination products in three product records, and a paediatric formulation is available in two product records.[1]
In the trials, diphtheria toxoid-containing vaccines such as Infanrix hexa and Tetravac are given as 0.5 ml intramuscular injections. The exact number of doses and schedule depend on the specific vaccine and the population being vaccinated, as described in the individual trial records.[4][1]
Five clinical trials in the registry involve diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, either as the studied substance, as an auxiliary medicine, or as a comparison product.[1]–[5]The role of the substance varies: it is listed as an auxiliary product in two trials, as the test substance in one trial, and as a placebo in one trial.[1]
The trials span Phase 1, Phase 1/2, Phase 2, and Phase 3. The largest is a completed Phase 1 study of a meningococcal vaccine with 703 participants, and the smallest is an authorised Phase 1/2 study in X-linked hyper-IgM syndrome with 6 participants.[4][3] Three of the five trials are authorised but not yet completed, while two are completed.[4][1]
The trials measure different things. The completed meningococcal vaccine study assessed safety and immune responses, including the proportion of participants with protective antibody titres against meningococcal serogroups A, C, W, Y, and B.[4] The pertussis study measured antibody concentrations against pertussis toxin in children at 4 years of age.[1] The myasthenia gravis study measures safety and changes in disease-specific scores such as the MG-ADL total score.[2] The HIGM1 study assesses dose-limiting toxicities, and the kidney disease study measures treatment-emergent adverse events.[3][5]
The supplementary sources provided do not contain specific side effect data for diphtheria toxoid adsorbed on aluminium hydroxide, hydrated. The clinical trial records list solicited administration site and systemic events, unsolicited adverse events, medically attended adverse events, serious adverse events, and adverse events of special interest as outcomes being measured, but do not report the results.[4] Side effect information for authorised combination vaccines containing diphtheria toxoid is available in the product information for those specific vaccines.
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