Experience with monocomponent acellular pertussis combination vaccines for infants, children, adolescents and adults—A review of safety, immunogenicity, efficacy and effectiveness studies and 15 years of field experience

Abstract

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.

Bordetella pertussisand pertactin-deficient clinical isolates: lessons for pertussis vaccines

“…Toxins are however not sufficient on their own to promote a successful colonization and B. pertussis also relies on the production of molecular anchors named adhesins. Denmark is the only country to use a pertussis monocomponent vaccine only containing hydrogen peroxidase detoxified PT (40 mg) [42]. All other acellular pertussis vaccines include B. pertussis adhesins in different combination (TABLE 1).…”

“…Although mono-component PT vaccine is effective [42], the selective pressure applied to the bacteria itself may be less strong than that applied through membrane proteins, especially knowing that these virulence factors have a role to play in the antibody-mediated phagocytosis of B. pertussis [72,73].…”

Combined Vaccine Is an Effective and Safe Protection From Five Controllable Infections

“…Regardless of the study population and the primary vaccination scheme, in all studies after primary vaccination course, which include 3 doses, high levels of seroconversion in relation to CT and PHA (82.9 and 83.9 -100 -95.9%, respectively) were detected [6]. It is also known that administration of the booster dose at the age of 1-2 years stimulates immune response and protective antibody titer in this case persists until the age of 5-7 and even 7-8 years (according to several authors) [10,11]. Thanks to low reactogenicity and high effectiveness confirmed by a major clinical trial, pentavalent vaccine Pentaxim, which contains the components necessary to protect infant against the primary dangerous infections, has been introduced to various immunization programs all over the world.…”

Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14–15 years

“…The present studies cannot address any of these issues, except that the adolescent study confirms a higher anti-PT response from a higher PT vaccine content, but whether or not there is a correlate to clinical effect is not known. In Denmark, the higher amounts of PT in monocomponent vaccines are considered to contribute to the control of pertussis, possibly together with the fact that PT epitopes may be less affected by inactivation [42].…”