Combination vaccines containing a monocomponent acellular
pertussis (aP)
vaccine, manufactured at Statens Serum Institut (SSI), Denmark, have successfully controlled Bordetella pertussis
infections in Denmark since 1997. The efficacy of this aP
vaccine was 71% in a double-blind, randomised and controlled clinical trial. Its safety and immunogenicity have been demonstrated in infants, children, adolescents and adults. In approximately 500,000 children it was effective against
pertussis requiring hospitalisation (VE: 93% after 3 doses) and against
pertussis not requiring hospitalisation (VE: 78% after 3 doses).
IgG antibodies against
pertussis toxin (
IgG anti-PT) response rates after booster vaccination of adults with
tetanus,
diphtheria and
aP combination vaccine (TdaP) were considerably higher for this monocomponent aP
vaccine containing 20μg
pertussis toxoid, inactivated by
hydrogen peroxide (92.0%), than for two multicomponent aP
vaccines inactivated by
formaldehyde and/or
glutaraldehyde: 3-component aP with 8μg
pertussis toxoid (77.2%) and 5-component aP with 2.5μg
pertussis toxoid (47.1%), without compromising the safety profile. In Denmark where this monocomponent aP
vaccine has been the only
pertussis vaccine in use for 15 years, there has been no
pertussis epidemic since 2002 (population incidence 36 per 100,000), in contrast to neighbouring countries, where epidemics have occurred. This monocomponent aP
vaccine can be used in
combination vaccines for primary and booster vaccination against
pertussis in all age groups and is an important tool for successful
pertussis control.