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Acellular pertussis vaccination of 2-month-old infants in the United States
M E Pichichero1, A B Francis, M M Blatter
1University of Rochester Medical Center, Department of Pediatrics, NY 14642.
Insights
The two-component acellular diphtheria-tetanus toxoids-pertussis (ADTP) vaccine showed superior immunogenicity and fewer adverse reactions compared to whole-cell DTP (WDTP) in a US infant study. This acellular pertussis vaccine offers a safer and more effective primary immunization option.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Whole-cell pertussis vaccines (WDTP) have been associated with adverse reactions.
- Acellular pertussis vaccines (ADTP) aim to improve safety and efficacy.
- Limited data existed on US infants comparing specific ADTP formulations to WDTP.
Purpose of the Study:
- To compare the immunogenicity and safety of a two-component ADTP vaccine versus WDTP in US infants.
- To evaluate antibody responses to key pertussis antigens.
- To assess the frequency of local and systemic adverse reactions.
Main Methods:
- A study of 380 US infants receiving primary immunization at 2, 4, and 6 months.
- 285 infants received the two-component ADTP vaccine; 95 received WDTP.
- Antibody responses (ELISA, CHO cell assay, agglutinin) and adverse events were measured after the third dose.
Main Results:
- ADTP vaccination resulted in significantly higher antibody responses to lymphocytosis-promoting factor and filamentous hemagglutinin compared to WDTP (P < .0001).
- Agglutinin responses were higher in WDTP recipients (P = .02).
- ADTP was associated with fewer local reactions and less frequent fever, irritability, drowsiness, anorexia, vomiting, and unusual crying.
Conclusions:
- The two-component ADTP vaccine demonstrated superior immunogenicity compared to WDTP in US infants.
- ADTP vaccination was associated with a significantly better safety profile, with fewer adverse effects.
- This ADTP vaccine represents a more effective and safer alternative for primary pertussis immunization.
Abstract:
This is the first study in children from the United States that evaluates the immunogenicity of and adverse reactions to the Connaught/Biken two-component acellular pertussis vaccine compared with whole-cell pertussis vaccine when given as a primary immunization series at 2, 4, and 6 months of age. Three hundred eighty infants were studied; 285 received acellular diphtheria-tetanus toxoids-pertussis (DTP (ADTP)) and 95 received whole-cell DTP (WDTP). Following the third dose, ADTP vaccination produced higher antibody responses than WDTP to lymphocytosis-promoting factor (enzyme-linked immunosorbent assay IgG geometric mean titer (GMT) = 131 vs 9 and Chinese hamster ovary cell assay GMT = 273 vs 16) and to filamentous hemagglutinin (IgG GMT = 73 vs 10) (all P less than .0001). Agglutinin responses were higher in WDTP compared with ADTP recipients (GMT = 50 vs 37; P = .02). Local reactions were fewer for all three doses following ADTP vaccination. Fever, irritability, drowsiness, anorexia, vomiting, and unusual crying all occurred less frequently in ADTP compared with WDTP recipients for one or more of the three doses. We conclude that this two-component ADTP vaccine when given as a primary series produces greater immunogenicity and fewer adverse effects than the currently licensed WDTP vaccine.