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Bordetella pertussis toxoid antigen (formaldehyde inactivated) is a vaccine antigen derived from the bacterium Bordetella pertussis, the cause of whooping cough. It is manufactured by treating the pertussis toxin with formaldehyde, which inactivates the toxin so that it can no longer cause disease while still triggering an immune response.[3] The substance is also known as Bordetella Pertussis Toxoid Antigen and carries the identifier DB14388 in the DrugBank database.[3]
The toxoid is an approved vaccine component. It received first approval in the United States in 1992 and in the European Union in 2021.[3] It is included in combination vaccines under the brand names Hexacima and Vaxelis.[3]
The toxoid works by exposing the immune system to an inactivated form of the pertussis toxin. Because the toxin has been rendered harmless by formaldehyde treatment, the body can safely learn to recognise it and produce antibodies against it. These antibodies then protect against future infection with Bordetella pertussis by neutralising the toxin before it can cause harm.[3]
In addition to its use as a vaccine antigen, a related Bordetella pertussis adenylate cyclase toxoid has been studied as a delivery system for peptide epitopes from other pathogens, such as Mycobacterium tuberculosis, into antigen-presenting cells. This research demonstrates the broader potential of pertussis-derived toxoids in vaccine development.[2]
The toxoid is given as part of combination vaccines by intramuscular injection. In the clinical trial, the vaccine Vaxelis was administered as a 0.5 millilitre suspension for injection in a pre-filled syringe.[1] The toxoid is not given alone; it is always combined with other vaccine antigens such as diphtheria, tetanus, hepatitis B, poliomyelitis and Haemophilus type b conjugate vaccine.[1]
One completed Phase 3 clinical trial, identified as NCT05856396, has investigated the toxoid as part of the combination vaccine Vaxelis. The trial, titled "Maternal determinants of infant immunity to pertussis (MADI-02)", enrolled 240 participants.[1]
The main objective was to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunised during pregnancy. Specifically, the study aimed to identify key predictors of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn, and of vaccine responses in infants.[1]
The primary outcome measured was the magnitude of the antibody responses to pertussis vaccination. The trial compared Vaxelis with another pertussis-containing vaccine, Triaxis, which is a diphtheria, tetanus and acellular pertussis vaccine with reduced antigen content.[1]
The trial is now completed, meaning that all participants have finished the study and data collection has ended.[1]
The provided sources do not contain specific information about the side effects of Bordetella pertussis toxoid adsorbed on aluminium phosphate. Side effect information for the combination vaccines containing this toxoid is available in the product information for those vaccines.
Research continues into the broader applications of pertussis-derived toxoids. A 2023 study published in Frontiers in Immunology demonstrated that the Bordetella pertussis adenylate cyclase toxoid can deliver Mycobacterium tuberculosis epitopes into antigen-presenting cells, expanding HLA-E-restricted cytotoxic CD8+ T cells that produce interferon-gamma and exert cytotoxic activity against infected macrophages. This work suggests potential future applications of pertussis toxoids in tuberculosis vaccination or immunotherapy.[2]
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