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Pertussis toxoid is a protein-based vaccine component derived from the toxin produced by Bordetella pertussis, the bacterium that causes whooping cough. It is included as an antigen in acellular pertussis vaccines, where the toxin has been inactivated so that it can trigger an immune response without causing disease. In the registry records, the full substance name is DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, PERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN), POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN), POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN), reflecting that it is always given as part of a fixed combination with other vaccine antigens.[1][2]
Pertussis toxoid is already authorised as a medicine in several European countries. In these registry records, the marketing authorisation is held by SANOFI PASTEUR EUROPE, and the substance appears under trade names including REPEVAX and Triaxis.[1][2] The Paul-Ehrlich-Institut lists pertussis vaccines as providing protection against infections with Bordetella pertussis, which causes whooping cough.[6]
Pertussis toxoid works by teaching the immune system to recognise and neutralise pertussis toxin, an exotoxin produced exclusively by Bordetella pertussis. Research published in 2003 showed that pertussis toxin plays an early role in respiratory tract colonisation by the bacterium, suggesting that antibodies against the toxin may help prevent the bacteria from establishing themselves in the airways.[7] The toxoid in vaccines is a chemically inactivated form of this toxin, which retains the shape the immune system needs to recognise but cannot cause the harmful effects of the active toxin.
Pertussis toxoid is given as a suspension for injection, administered by intramuscular injection or injection according to the product records in these trials.[1][2] The vaccines are supplied in pre-filled syringes, with the product information describing a 0.5 ml dose for the combination vaccines used in the trials. The substance is always given as part of a fixed combination with other vaccine antigens, never as a standalone product.
Four phase 3 trials are registered for vaccines containing pertussis toxoid. Three are completed, and one is authorised but not yet started. The trials enrolled between 96 and 240 participants each.
The largest trial, NCT05856396, enrolled 240 participants and measured the magnitude of antibody responses to pertussis vaccination in infants born to mothers immunised during pregnancy.[3] A trial with 99 healthy adults (2023-508416-35-00) tested whether a Tdap-IPV booster reduced Bordetella pertussis colonisation after intranasal challenge, measuring colonisation by positive bacterial cultures from nasal wash samples between day 3 and day 28 after challenge.[1]
A completed trial in 100 health care workers (2024-511478-56-00) measured the percentage of participants with pertussis toxin-specific IgG antibody levels of at least 5 IU/mL before vaccination and the immune response four weeks after a dTap booster.[2] The authorised trial NCT06466629 plans to enrol 96 pregnant women and will measure antibody levels and functional antibody characteristics after Tdap vaccination at different times during pregnancy.[4]
The trials cover three distinct populations. Two trials enrolled pregnant women to study maternal immunisation and antibody transfer to infants.[3][4] One trial enrolled health care workers to assess immunity before and after booster vaccination.[2] One trial enrolled healthy adults for a controlled human infection study.[1] All participants in the completed trials were adults; no paediatric trial is present in these records.
The sources provided do not include a detailed side-effect profile for pertussis toxoid. The Paul-Ehrlich-Institut listing describes pertussis vaccines as providing protection against Bordetella pertussis infection but does not enumerate adverse reactions.[6] The NHS formulary reference lists pertussis-containing vaccines among immunological products but does not provide a side-effect list within the source content.[5]
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