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Pertussis filamentous haemagglutinin is a protein-based substance derived from the bacterium Bordetella pertussis, the organism that causes whooping cough. It is a component of acellular pertussis vaccines, where it is combined with other pertussis antigens such as pertussis toxoid and pertactin.[5] In the EU Clinical Trials Information System, the substance appears as part of fixed-combination vaccines including REPEVAX and Triaxis, which are authorised as medicines in several countries.[1] The marketing authorisation holder for these products is Sanofi Pasteur Europe.[1]
Filamentous haemagglutinin is a surface protein of Bordetella pertussis that helps the bacterium attach to cells in the respiratory tract. When included in a vaccine, it stimulates the immune system to produce antibodies against this protein. A study published in 2006 examined the immunogenicity and protective efficacy of a recombinant form of filamentous haemagglutinin, indicating that this component is important for generating protective immune responses.[5] In the registered trials, the antibody response to pertussis vaccination is measured as a key outcome, including the magnitude of antibody responses in infants born to vaccinated mothers.[3]
The substance is administered as a suspension for injection, given by intramuscular injection. In the registered trials, the vaccines containing pertussis filamentous haemagglutinin are provided in pre-filled syringes at a volume of 0.5 ml per dose.[1] The pharmaceutical form is consistently a suspension for injection across the product records.[2]
Four phase 3 interventional trials involving pertussis filamentous haemagglutinin as a vaccine component are registered. Three trials are completed and one is authorised.[1]–[4]The trials include a total of 535 enrolled participants across different populations. The largest trial enrolled 240 participants and examined maternal determinants of infant immunity to pertussis, measuring the magnitude of antibody responses to pertussis vaccination.[3] The smallest trial enrolled 96 pregnant women and assessed the impact of timing of pertussis vaccination in pregnancy on immune responses.[4] One completed trial with 99 participants investigated whether booster vaccination with a Tdap-IPV vaccine reduces colonisation with Bordetella pertussis after controlled human infection.[1] A further trial with 100 healthcare workers studied immunity to pertussis, diphtheria, and tetanus before and after booster vaccination.[2]
The registered trials include different populations. One trial enrolled healthy adults for a controlled human infection study.[1] Another trial enrolled pregnant women to study vaccination timing during pregnancy.[4] A third trial enrolled healthcare workers before their booster vaccination.[2] The fourth trial involved infants born to mothers immunised during pregnancy, with the aim of identifying determinants of antibody-mediated immunity to pertussis in these infants.[3]
The supplementary source provided does not report specific side effects for pertussis filamentous haemagglutinin. The published article focuses on immunogenicity and protective efficacy rather than adverse events.[5]
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