In short
Pertussis fimbrial agglutinogens (FIM) 2 and 3 are protein components of acellular pertussis vaccines, used as part of fixed combinations that protect against whooping cough and related infections. They are authorised as a medicine and appear as the test substance in two of the four trials listed here. The trials involve 535 participants in total across phase 3 studies, including studies in pregnant women and healthcare workers.
Pertussis fimbrial agglutinogens (FIM) 2 and 3 are protein components found in acellular pertussis vaccines. They are part of a fixed combination with diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertussis pertactin, and inactivated poliovirus types 1, 2 and 3.
Key points
- Pertussis fimbrial agglutinogens (FIM) 2 and 3 are components of acellular pertussis vaccines, authorised as a medicine held by Sanofi Pasteur Europe.
- The substance is part of a fixed combination vaccine with diphtheria, tetanus, and other pertussis antigens.
- Four phase 3 trials are listed, with enrollment ranging from 96 to 240 participants.
- Trials study the vaccine in whooping cough, in pregnant women, and in healthcare workers.
- One trial uses a controlled human infection model to measure whether the vaccine reduces colonisation with Bordetella pertussis.
- All four trials are completed except one, which is authorised but not yet started.
What is pertussis fimbrial agglutinogens (FIM) 2 and 3?
Pertussis fimbrial agglutinogens (FIM) 2 and 3 are protein components of acellular pertussis vaccines. The substance is authorised as a medicine, with authorisation records listed in the product records of the trials. The marketing authorisation holder is Sanofi Pasteur Europe. The substance appears in product records under the names REPEVAX and Triaxis, both as suspensions for injection in pre-filled syringes. In two product records, the substance is part of a fixed combination.
How does pertussis fimbrial agglutinogens (FIM) 2 and 3 work?
As components of acellular pertussis vaccines, pertussis fimbrial agglutinogens (FIM) 2 and 3 are among the antigens that stimulate the immune system to produce antibodies against Bordetella pertussis, the bacterium that causes whooping cough. The trials measure antibody responses such as pertussis toxin-specific IgG geometric mean concentrations, and one trial measures whether vaccination reduces colonisation with Bordetella pertussis after a controlled human infection challenge.
Which conditions is pertussis fimbrial agglutinogens (FIM) 2 and 3 used or studied for?
- Pertussis (whooping cough) — a bacterial infection of the airways caused by Bordetella pertussis, studied in two trials including a controlled human infection model.
- Diphtheria and tetanus — the fixed combination vaccine also targets these bacterial diseases, studied in healthcare workers.
- Pregnancy — the timing of vaccination in pregnancy is studied for its effect on antibody transfer to the newborn.
How is pertussis fimbrial agglutinogens (FIM) 2 and 3 given?
The substance is given as a suspension for injection, by intramuscular injection, in pre-filled syringes. The product records list a 0.5 ml dose for the fixed combination vaccines.
What do the clinical trials show?
Which conditions are studied in the trials?
Four phase 3 trials are listed, all interventional. Two trials study pertussis or whooping cough directly. One trial studies diphtheria, tetanus and pertussis immunity in healthcare workers. One trial studies the timing of vaccination in pregnancy. The substance itself appears as the test substance in two trials.
What phases and status do the trials have?
All four trials are phase 3 studies. Three are completed; one is authorised but not yet started.–[4]Enrollment ranges from 96 participants in the pregnancy timing trial to 240 in the maternal determinants trial.
What are the trials measuring?
The controlled human infection trial measures the Bordetella pertussis colonisation rate in the Tdap-IPV and Td-IPV vaccination groups, defined as any positive culture from nasal wash samples between day 3 and day 28 after challenge. The healthcare worker trial measures the percentage of participants with pertussis toxin-specific IgG antibody geometric mean concentration of at least 5 IU/mL before vaccination. The maternal determinants trial measures the magnitude of antibody responses to pertussis vaccination in infants born to mothers immunised during pregnancy. The pregnancy timing trial measures antibody levels and functional antibody characteristics in maternal blood at baseline, after Tdap vaccination, at delivery, and six months postpartum.
Who can take part in these trials?
The controlled human infection trial enrolled healthy adults. The healthcare worker trial enrolled healthcare workers before their booster vaccination. The maternal determinants trial enrolled pregnant women and their infants. The pregnancy timing trial enrolled pregnant women.