Diphtheria and Tetanus Toxoids and Acellular -Pertussis Vaccine Adsorbed - Pertugen; Triacel--l-uvax; [with recombinant pertussis toxoid]
Status: FDA filing withdrawn; formerly approved in EU
Organizations involved:
Chiron S.p.A. – Manuf.; R&D; Tech.; Europe mark.; Former
Chiron Corp. – Parent; Former
Evans Vaccines Ltd. – Patent dispute
Cross ref: See the entry (#236) for the recombinant per-tussis toxin vaccine component of this vaccine in the Recombinant DNA Products section. See the entry for Pertussis Vaccines, Acellular (#506), and Diphtheria and Pertussis Toxoids and Pertussis Vaccine (DTP/DTaP) Products (#429). See the entries for Tetanus Toxoid Products (#543); and Diphtheria Toxoid Products (#418). See also entries for entries for this vaccine’s component diphtheria and tetanus toxoids.
Description: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed or Pertugen is a DTaP vaccine from Chiron Corp. (merged into Novartis AG in spring 2006) containing conventional diphtheria and tetanus toxoids, with the pertussis component containing conventional purified filamentous hemagglutinin (FHA) and pertactin (69 kDa protein), plus recombinant pertussis toxin which has been dotoxified/inactivated (to toxoid) by recombinant DNA methods (e.g., sequence deletions).
Nomenclature: DTaP Vaccine/Chiron [BIO]; Pertugen [TR U.S.; no plans for use]; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [FDA unofficial; not FDA approved]; Triacelluvax [TR in European Union except Germany]; DTPa [CDC]; DTaP3-CB [SY]
Companies.: The vaccine was developed, manufactured and marketed by Chiron S.p.A. (Chiron Vaccines), CBER/FDA est. no. 1222, a subsidiary of Chiron Corp. (which has now been merged into Novartis AG).
FDA class: Biologic PLA
Status: Chiron Corp. filed a PLA for FDA approval of Pertugen on Oct. 1, 1996, and voluntarily withdrew this application on Feb. 2, 1999. The company cited competitive reasons. With four DTaP vaccines then in the U.S. market and Chiron then having only seven vaccine sales reps in the U.S. (handling its rabies vaccine), the company decided to concentrate on its plans for marketing in Europe, where the company had about 300 sales reps.
The vaccine received its first approval in Italy in Dec. 1994. European Union approval of Triacelluvax was granted on Jan. 11, 1999. However, the vaccine was only ever marketed in Italy. On March 7, 2002 , Biocine/Chiron voluntarily withdrew its European Union approval.
Tech. transfer: In March 1998, Chiron won a European patent dispute brought by Evans Medical, then recently acquired by Powder-Ject Pharmaceuticals plc (later acquired by Chiron), resulting in revocation of Evans’/Medeva’s European Patent 0-162,639 concerning pertactin. Evans/Medeva had alleged that Triacelluvax infringed this patent. Evans/Medeva had exclusively licensed pertactin and other pertussis vaccine technology to SmithKline Beecham S.A., now GlaxoSmithKline, for use in Infanrix (#433). Chiron (now Novartis), presumably, received royalties from sales of Infanrix.
Trials: Pertugen, like other DTaP vaccines, induces protective immunity against diphtheria and tetanus, and variable immune responses to its different pertussis antigen components. In clinical studies, antibody responses to pertussis toxin were normally higher with Pertugen than with other combination vaccines containing a pertussis vaccine component. Pertugen was at least as efficacious as most whole cell pertussis vaccines and was similar in efficacy to the most efficacious acellular pertussis vaccines containing 3 or more pertussis antigens.
A pivotal clinical trial conducted in Italy in 15,601 infants comparing a whole-cell pertussis component DTP vaccine (from Sanofi Pasteur), a chemically detoxified acellular pertussis component DTaP vaccine (Certiva), and Triacelluvax (Pertugen) DTaP was reported in the Feb. 8, 1996 issue of the New England Journal of Medicine. Both DTaP vaccines resulted in fewer adverse effects, and Triacelluvax was more than twice as effective than the whole-cell DTP vaccine.
Index Terms:
Companies involvement:
Full monograph
432 DTaP Vaccine/Chiron
Nomenclature:
DTaP Vaccine/Chiron [BIO]
Pertugen [TR U.S. trade name; no plans for use]
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [FDA [unofficial; not FDA approved]]
DTaP3-CB [SY]
DTPa [CDC abbrev.]
Triacelluvax [TR [used in European Union except for Germany]]
FDA Class: Biologic BLA
biopharmaceutical products
vaccines, bacterial
vaccines, combination
bacterial culture <!-- bacterialculture -->
Bordetella pertussis
Clostridium tetani
Corynebacterium diphtheriae
aluminum adjuvant
Bordetella pertussis
Diphtheria Toxoid
filamentous hemagglutinin (FHA), Bordetella pertussis
formaldehyde
pertactin (69 kDa protein)
pertussis toxin (PT)
Pertussis Vaccine Adsorbed, Acellular
Tetanus Toxoid
Tetanus Toxoid Adsorbed
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
FDA application withdrawn
North American coral snake
North American coral snake
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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