Related Experiment Videos
An open study evaluating the reactogenicity and immunogenicity of a DTP vaccine containing an acellular pertussis
Insights
This study found that an acellular pertussis vaccine booster was safe and immunogenic in four to six-year-old children. The vaccine showed fewer reactions than whole-cell pertussis vaccines, supporting its potential use.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Acellular pertussis vaccines are widely used in Japan but less evaluated in the US.
- Previous US pertussis vaccines utilized whole-cell components.
Purpose of the Study:
- To evaluate the safety and immunogenicity of an acellular pertussis vaccine component as a booster in US children.
- To compare reactions and antibody responses to a Takeda acellular pertussis vaccine against existing US whole-cell pertussis vaccines.
Main Methods:
- A trial involving 36 children aged 4-6 years who had previously received four doses of whole-cell DTP vaccine.
- Administration of a DTP vaccine containing diphtheria and tetanus toxoids and 300 HA units of Takeda acellular pertussis component.
- Monitoring of local and systemic reactions for 48 hours post-vaccination and measurement of pre- and post-immunization antibody levels (agglutinin, filamentous hemagglutinin [FHA], and lymphocytosis promoting factor [LPF]).
Main Results:
- Common reactions included redness (50%), tenderness (50%), and swelling (41%). Systemic reactions like fever (3%), drowsiness (17%), and fretfulness (14%) were infrequent.
- Significant increases in antibody titers were observed: agglutinin GMT (1:21 to 1:100), FHA (28 to ≥229 ELISA units), and LPF (176 to 1732 ELISA units).
Conclusions:
- The acellular pertussis vaccine component demonstrated a favorable safety profile with reduced reactogenicity compared to US whole-cell pertussis vaccines.
- The vaccine proved immunogenic when administered as a booster dose in four to six-year-old children, suggesting potential for future vaccination strategies.
- Further research is recommended to assess the vaccine's safety and immunogenicity in younger, previously unimmunized populations.
Abstract:
Acellular pertussis vaccines have been used for mass immunization of children in Japan since the fall of 1981, but until recently they have not been evaluated in the United States. We report a trial with a DTP vaccine containing an acellular pertussis component in 36 four to six year old children who had previously received four doses of United States DTP licensed vaccine with a whole cell pertussis vaccine component. The study vaccine contained diphtheria and tetanus toxoids and 300 HA units of Takeda acellular pertussis component. The principle immunizing antigens in the pertussis component of the vaccine were lymphocytosis promoting factor (LPF) and filamentous hemagglutinin (FHA). Local and systemic reactions were monitored during the first 48 hours after vaccination, and pre-immunization and one month post-immunization serum specimens were obtained for antibody assay. The following reaction rates were noted: redness 50%, tenderness 50%, swelling 41%, fever (greater than or equal to 38 degrees C) 3%, drowsiness 17%, fretfulness 14%, anorexia 11%, and vomiting 6%. Pertussis antibody values (preimmunization/postimmunization) were as follows: agglutinin GMT, 1:21/1:100; FHA mean ELISA u, 28 +/- 6/greater than or equal to 229 +/- 47; LPF mean ELISA u, 176 +/- 59/1732 +/- 280. The pertussis component of the study vaccine would appear to be less reactogenic than United States whole cell pertussis vaccines but still immunogenic when given as a booster immunization to four to six year old children. Further studies are needed to assess reactions and immunogenicity in younger and previously unimmunized children.