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Published on: February 22, 2019
Immunogenicity and reactogenicity of two diphtheria-tetanus-whole cell pertussis vaccines in Iranian pre-school
Saeed Zarei1, Mahmood Jeddi-Tehrani, Mohammad Mehdi Akhondi
1Monoclonal Antibody Research Center; Avicenna Research Institute; Academic Center for Education, Culture, and Research (ACECR); Tehran, Iran; Reproductive Immunology Research Center; Avicenna Research Institute; ACECR; Tehran, Iran.
Insights
A study compared two diphtheria-tetanus-whole cell pertussis (DTwP) vaccines in Iranian children. The local DTwP vaccine showed lower immunogenicity against pertussis and more side effects than the commercial DTwP-Pasteur vaccine.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Diphtheria-tetanus-whole cell pertussis (DTwP) vaccines are crucial for preschool child immunization.
- Evaluating local vaccine efficacy and safety against established commercial vaccines is essential for public health.
Purpose of the Study:
- To compare the immunogenicity and reactogenicity of a local DTwP vaccine versus a commercial DTwP-Pasteur vaccine in Iranian preschool children.
- To assess antibody responses to diphtheria, tetanus, and pertussis antigens.
- To evaluate local and systemic adverse reactions following vaccination.
Main Methods:
- A randomized, double-blind, multicenter prospective study involving 672 children aged 4-6 years.
- Administration of either a local DTwP vaccine or DTwP-Pasteur vaccine according to the national immunization schedule.
- Assessment of immunogenicity via ELISA and reactogenicity through parental diary cards for seven days post-vaccination.
Main Results:
- No significant difference in immunogenicity against diphtheria and tetanus was observed between the two vaccines.
- The local DTwP vaccine demonstrated significantly lower antibody titers against pertussis compared to DTwP-Pasteur (30.2 EU/ml vs. 47.9 EU/ml).
- The local DTwP vaccine was associated with significantly higher frequencies of local and systemic reactions, including pain and fever.
Conclusions:
- While immunogenicity for diphtheria and tetanus was comparable, the local DTwP vaccine was less effective against pertussis.
- The local vaccine exhibited a higher reactogenicity profile, suggesting potential differences in bacterial strain, preparation, or formulation.
- These findings highlight the need for further investigation into the local pertussis vaccine's components to improve efficacy and reduce adverse events.
Abstract:
The present study was undertaken to compare the immunogenicity and reactogenicity of two diphtheria-tetanus-whole cell pertussis (DTwP) vaccines administered to Iranian preschool children. In this randomized, double-blind and multicenter prospective study, 672 children aged 4-6 y were administered with either a local DTwP vaccine (DTwP-Local) (n = 337) or a commercial vaccine (DTwP-Pasteur) (n = 335). All subjects received DTwP vaccine at 4-6 y of age, following the national immunization schedule of Iran. Blood samples were collected before and 2-4 weeks after the vaccination. Immunogenicity of each vaccine was assessed by ELISA using commercial kits. Reactogenicity was assessed by the parents for seven days post-booster using diary cards. The geometric mean titers (GMTs) of the antibodies induced against diphtheria and tetanus by DTwP-Local were 7.7 and 9.4 IU/ml and those of DTwP-Pasteur were 8.2 and 8.6 IU/ml, respectively. There was no significant difference between the immunogenicity of the two vaccines against diphtheria and tetanus. The GMTs of antibodies produced against pertussis were 30.2 EU/ml for DTwP-Local and 47.9 EU/ml for DTwP-Pasteur vaccines (p<0.001). Pain and fever (axillary temperature>37.5°C) were the most frequent local and systemic reactions observed after the vaccination. All local and systemic reactions observed after vaccination were significantly higher in subjects immunized with DTwP-Local vaccine. Immunogenicity against diphtheria and tetanus was similar for the two vaccines, but immunogenicity of the local vaccine against pertussis was significantly less efficient than that of DTwP-Pasteur. This difference and the higher side effects of the DTwP-Local vaccine could be due to the bacterial strain or the preparation or formulation protocol of the local pertussis vaccine.
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