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Tetanus toxoid adsorbed on aluminium phosphate is an inactivated bacterial toxin used as an active ingredient in vaccines. It is produced by growing Clostridium tetani, the bacterium that causes tetanus, and detoxifying the toxin it produces with formaldehyde. The toxoid is then purified and adsorbed onto aluminium phosphate to enhance the immune response.
Tetanus toxoid adsorbed on aluminium phosphate is a vaccine component derived from the tetanus toxin. The toxin is produced by Clostridium tetani and is detoxified with formaldehyde before being purified and adsorbed onto aluminium phosphate.[2] Each 0.5 ml dose of a tetanus and diphtheria toxoid vaccine contains 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid, along with an aluminium adjuvant.[2] Tetanus toxoid is not given as a standalone product in most settings; it is available as part of combined vaccines.[3]
Tetanus is caused by an extremely potent neurotoxin produced by Clostridium tetani. Protection against the disease depends on the development of neutralising antibodies to this toxin.[2] When tetanus toxoid is injected, the immune system recognises the inactivated toxin and produces antibodies against it. A serum tetanus antitoxin level of 0.01 IU/ml, measured by a neutralisation assay, is considered the minimum protective level.[2] In a study of adults with very low pre-immunisation antitoxin levels, 70% achieved protective levels after two doses, and all 16 adults tested achieved protective levels after three doses.[2]
Tetanus toxoid is given by intramuscular injection as part of combination vaccines. The vaccine containing tetanus and diphtheria toxoids appears as a homogenous milky white suspension after shaking.[2] In the Phase 3 trial, the combination vaccine Vaxelis containing tetanus toxoid was given as a 0.5 ml intramuscular injection.[1] Tetanus vaccines are available as combined vaccines rather than as a standalone product.[3]
One Phase 3 trial (NCT05856396) studied tetanus toxoid as part of the Vaxelis combination vaccine in 240 pregnant women and their infants.[1] The trial, titled "Maternal determinants of infant immunity to pertussis (MADI-02)", was interventional and has been completed.[1] The main objective was to identify determinants of antibody-mediated immunity to pertussis in infants born to mothers immunised during pregnancy. Specifically, the trial aimed to identify predictors of vaccine responses in pregnant women, the transfer of maternal antibodies to the newborn, and vaccine responses in infants.[1]
The primary outcome measured in this trial is the magnitude of the antibody responses to pertussis vaccination.[1] The trial also examined how maternal antibodies are transferred to the newborn and how infants respond to vaccination after birth.[1]
The supplementary sources provided do not include detailed side effect information for tetanus toxoid. The vaccine contains residual formaldehyde (less than 100 mcg per dose) and a trace amount of thimerosal from the manufacturing process.[2] No side effect data from the clinical trial or other provided sources is available for this page.
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