DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate, for intramuscular injection.
Each 0.5 mL dose contains diphtheria and tetanus toxoids and acellular pertussis
antigens (detoxified PT, FHA, PRN and FIM). [See Dosage
Forms and Strengths.]
Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤ 5 µg residual formaldehyde, < 50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The vial stopper is composed of dry natural latex rubber.
The acellular pertussis vaccine components are produced from Bordetella
pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition
of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated
separately from the supernatant culture medium. The FIM components are extracted
and co-purified from the bacterial cells. The pertussis antigens are purified
by sequential filtration, salt-precipitation, ultrafiltration and chromatography.
PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde, and
the residual aldehydes are removed by ultrafiltration. The individual antigens
are adsorbed separately onto aluminum phosphate.
Corynebacterium diphtheriae is grown in modified Mueller's growth medium.
(4) After purification by ammonium sulfate fractionation, diphtheria toxin is
detoxified with formaldehyde and diafiltered. Clostridium tetani is grown
in modified Mueller-Miller casamino acid medium without beef heart infusion.
(5) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate
fractionation and diafiltration. Diphtheria and tetanus toxoids are individually
adsorbed onto aluminum phosphate.
The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.
Both diphtheria and tetanus toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test. The potency of the acellular pertussis vaccine components is determined by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).
Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.