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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.[1][2]
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.[1] The marketing authorisation holder is Sanofi Pasteur Europe.[1] The substance appears in product records under the names REPEVAX and Triaxis, both as suspensions for injection in pre-filled syringes.[1][2] In two product records, the substance is part of a fixed combination.[1]
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.[1][2]
The substance is given as a suspension for injection, by intramuscular injection, in pre-filled syringes.[1][2] The product records list a 0.5 ml dose for the fixed combination vaccines.[1][2]
Four phase 3 trials are listed, all interventional. Two trials study pertussis or whooping cough directly.[1][3] One trial studies diphtheria, tetanus and pertussis immunity in healthcare workers.[2] One trial studies the timing of vaccination in pregnancy.[4] The substance itself appears as the test substance in two trials.[1][2]
All four trials are phase 3 studies. Three are completed; one is authorised but not yet started.[1]–[4]Enrollment ranges from 96 participants in the pregnancy timing trial to 240 in the maternal determinants trial.[3][4]
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.[1] 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.[2] The maternal determinants trial measures the magnitude of antibody responses to pertussis vaccination in infants born to mothers immunised during pregnancy.[3] 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.[4]
The controlled human infection trial enrolled healthy adults.[1] The healthcare worker trial enrolled healthcare workers before their booster vaccination.[2] The maternal determinants trial enrolled pregnant women and their infants.[3] The pregnancy timing trial enrolled pregnant women.[4]
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