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Comparison of a three-component acellular pertussis vaccine with a whole-cell pertussis vaccine in 15- through
H H Bernstein1, E P Rothstein, K S Reisinger
1Temple University School of Medicine, Philadelphia, PA.
Insights
The three-component acellular pertussis vaccine (DTaP) showed higher immune responses to pertussis antigens and was less reactogenic than the whole-cell pertussis vaccine (DTwP) in infants. DTaP also provided equivalent immune responses to diphtheria and tetanus toxoids.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Whole-cell pertussis vaccines (DTwP) have been associated with significant reactogenicity.
- Acellular pertussis vaccines (DTaP) aim to reduce adverse events while maintaining efficacy.
- Booster doses are crucial for sustained immunity in young children.
Purpose of the Study:
- To compare the immunogenicity and reactogenicity of a three-component DTaP vaccine versus a DTwP vaccine.
- To evaluate vaccine response in infants aged 15-20 months receiving a booster dose.
- To assess antibody levels against pertussis, diphtheria, and tetanus toxoids.
Main Methods:
- A randomized, double-blind, comparative study was conducted in three pediatric practices.
- 165 healthy infants (15-20 months) received either DTaP or DTwP vaccine.
- Serum samples were collected pre-vaccination and 4 weeks post-vaccination; adverse events were monitored for 7 days.
Main Results:
- DTaP elicited significantly higher IgG antibody levels to pertussis toxoid, filamentous hemagglutinin, and pertactin compared to DTwP (P < .003).
- Antibody levels for diphtheria and tetanus toxoids were equivalent between the DTaP and DTwP groups (P > .05).
- Local and systemic adverse experiences were significantly fewer following DTaP immunization compared to DTwP (P < .05).
Conclusions:
- The three-component DTaP vaccine is superior to DTwP in terms of immunogenicity against pertussis components.
- DTaP demonstrates comparable immunogenicity for diphtheria and tetanus toxoids.
- DTaP offers a favorable safety profile with reduced reactogenicity compared to DTwP in infants.
Objective:
To compare the immunogenicity and reactogenicity of a diphtheria and tetanus toxoids and three-component acellular pertussis vaccine (DTaP) with a diphtheria and tetanus toxoids and whole-cell pertussis vaccine (DTwP) when administered as a booster dose to infants 15 through 20 months of age.
Design:
Randomized, double-blind, comparative study.
Setting:
Three pediatric practices (two private; one hospital-based).
Participants:
One hundred and sixty-five healthy 15- through 20-month old infants. SELECTION PROCEDURES AND INTERVENTIONS: Infants were randomly assigned in a 2:1 ratio to receive vaccine from a single lot of DTaP or from commercially available DTwP. DTaP contained 25 micrograms of pertussis toxoid, 25 micrograms of filamentous hemagglutinin, 8 micrograms of pertactin (69-kilodalton outer membrane protein), 25 flocculating units of diphtheria toxoid, and 10 flocculating units of tetanus toxoid per 0.5-mL dose. DTwP contained one half the concentrations of diphtheria and tetanus toxoids compared with DTaP and a pertussis component with a potency of 4 U/0.5-mL dose. Serum samples were obtained on the day of immunization and 4 weeks later. Adverse reactions were recorded by parents for 7 days after immunization. An interval history was obtained 4 weeks after immunization.
Measurements And Results:
IgG antibody to pertussis toxoid, filamentous hemagglutinin, pertactin, diphtheria toxoid, and tetanus toxoid was measured by an indirect enzyme-linked immunosorbent assay (ELISA) method. One month after immunization, the geometric mean antibody levels after DTaP compared with DTwP were: pertussis toxoid, 70.6 vs 28 ELISA U/mL (P = .003); filamentous hemagglutinin, 183.4 vs 43 ELISA U/mL (P < .001); pertactin, 216 vs 49.9 ELISA U/mL (P < .001); diphtheria, 14.1 vs 14.9 IU/mL (P = .74); and tetanus, 11.9 vs 14.8 IU/mL (P = .089). After immunization with DTaP, most local and systemic adverse experiences were significantly fewer compared with DTwP (P < .05).
Conclusions:
This three-component DTaP vaccine demonstrates significantly greater immune responses to pertussis toxoid, filamentous hemagglutinin, and pertactin, equivalent immune responses to diphtheria and tetanus toxoids, and significantly less reactogenicity compared with a licensed DTwP.