In short
Bordetella Pertussis Fimbriae Type 2 and 3 is a protein-based vaccine component from the bacterium that causes whooping cough, and it is studied as part of combination vaccines. In one completed Phase 3 trial, 240 participants were followed to understand how maternal vaccination affects antibody transfer to infants and their own vaccine responses. The trial measured the magnitude of antibody responses to pertussis vaccination after mothers were immunised during pregnancy.
Key points
- Bordetella Pertussis Fimbriae Type 2 and 3 is a protein-based vaccine component used in combination vaccines against whooping cough.
- The vaccine component is given as a 0.5 ml intramuscular injection in the trials.
- One completed Phase 3 trial with 240 participants investigated maternal determinants of infant immunity to pertussis.
- The primary outcome measured was the magnitude of antibody responses to pertussis vaccination.
- The trial studied vaccination in pregnant women and the transfer of antibodies to their newborns.
What is Bordetella pertussis fimbriae type 2 and 3?
Bordetella Pertussis Fimbriae Type 2 and 3 is a protein-based vaccine component. It is derived from Bordetella pertussis, the bacterium that causes whooping cough (pertussis). The fimbriae are hair-like structures on the surface of the bacterium that help it attach to cells in the airways. In vaccines, this component is adsorbed on aluminium phosphate, which acts as an adjuvant to strengthen the immune response. In the registered trial, the component appears as part of combination vaccines: Vaxelis, which also contains diphtheria, tetanus, pertussis (acellular, component), hepatitis B, poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine, and Triaxis, a diphtheria, tetanus and pertussis (acellular) vaccine with reduced antigen content.
How does Bordetella pertussis fimbriae type 2 and 3 work?
Vaccines containing Bordetella Pertussis Fimbriae Type 2 and 3 work by presenting parts of the pertussis bacterium to the immune system. This trains the body to recognise and respond to the bacterium without causing the disease itself. The trial data focus on antibody-mediated immunity: the trial aimed to identify key predictors of vaccine responses in pregnant women, the transfer of maternal antibodies to the newborn, and vaccine responses in infants. The primary outcome measured the magnitude of the antibody responses to pertussis vaccination, which reflects how strongly the immune system reacts after vaccination.
Which conditions is it used or studied for?
- Whooping cough (pertussis) — a highly contagious respiratory infection caused by Bordetella pertussis that causes severe coughing fits and can be dangerous for infants. The vaccine component is studied for prevention of this disease through maternal and infant immunisation.
How is Bordetella pertussis fimbriae type 2 and 3 given?
In the registered trial, the vaccines containing this component were given as a 0.5 ml suspension for injection by intramuscular injection. The vaccines were provided in pre-filled syringes.
What do the clinical trials show?
One completed Phase 3 interventional trial (NCT05856396) investigated maternal determinants of infant immunity to pertussis. The trial enrolled 240 participants and focused on pregnant women who were immunised during pregnancy, their newborns, and the subsequent vaccine responses in infants. The main objective was to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunised during pregnancy. The primary outcome measured the magnitude of antibody responses to pertussis vaccination. The trial status is completed.
What side effects are known?
No side effect information is available from the trial registry data for this substance.