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Immunogenicity and Complications of the Pentavalent Vaccine in Iranian Children
Mina Ekrami Noghabi1, Mohammad Jafar Saffar1, Shaghayegh Rezai2
1Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.
Insights
The Pentavalent vaccine in Iran demonstrates high immunogenicity against diphtheria, tetanus, hepatitis B, and Hib infections in children. While generally safe with minimal side effects, its pertussis component shows lower efficacy, warranting continued monitoring.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- The Pentavalent vaccine, protecting against diphtheria, tetanus, pertussis, hepatitis B (HepB), and Haemophilus influenzae type b (Hib), was integrated into Iran's national immunization program in November 2014.
- Assessing vaccine safety and immunogenicity is crucial for public health strategies, especially following program updates.
Purpose of the Study:
- To evaluate the adverse events and immunogenicity of the Pentavalent vaccine in Iranian children.
- To assess the antibody titers against diphtheria, tetanus, pertussis, HepB, and Hib following a three-dose vaccination schedule.
Main Methods:
- A descriptive-analytical study involving children receiving three doses of the Pentavalent vaccine.
- Blood samples collected pre-vaccination and four weeks post-booster dose to measure antibody titers using ELISA.
- Adverse events (local and systemic) were monitored for seven days post-vaccination.
Main Results:
- High immunogenicity was observed for tetanus (100%), Hib (98.7%), HepB (98.7%), and diphtheria (93.1%).
- Pertussis immunogenicity was lower at 63.7%.
- The most frequent systemic reaction was fever; no severe complications were reported.
Conclusions:
- The Pentavalent vaccine in Iran elicits a robust antibody response for most targeted antigens with a favorable safety profile.
- The lower immunogenicity for pertussis suggests a need for further investigation or potential vaccine strategy adjustments.
- The study supports the continuation of replacing the DTP vaccine with the Pentavalent vaccine in Iran.
Abstract:
Objective: Vaccination is one of the most convenient and safe preventive care measures available for children. The Pentavalent vaccine which protects against five major infections including diphtheria, tetanus, pertussis, hepatitis B(HepB) and Haemophilus influenzae type b(Hib) was added to the Iranian national immunization program in November 2014. This study aimed to determine the Pentavalent vaccine adverse events and immunogenicity in an Iranian children population in Sari, northern Iran. Method: In this descriptive-analytical study, children who were vaccinated with three doses of the Pentavalent vaccine were studied. Two venous blood samples were obtained before the first dose and 4 weeks following the last booster dose. Possible local and systemic complications of the vaccine were recorded until 7 days following vaccination. Antibody titers were measured by quantitative ELISA kits and geometric mean titer(GMT) was calculated for each vaccine component before and after 3 doses of vaccine. Statistical analysis was performed by SPSS 20.0 software and Chi-square and Fisher's exact tests were used for analysis. Results: Immunogenicity of the Pentavalent vaccine for tetanus was 100%(GMT:2.52 Eu/mL, 95%CI: 2.22-2.88), Hib 98.7%(GMT:2.44 Eu/mL, 95%CI: 2.06-2.89), HepB 98.7%(GMT:153.54 Eu/mL, 95%CI: 133.73-176.29), diphtheria 93.1%(GMT:0.43 Eu/mL, 95%CI:0.37-0.51) and pertussis were 63.7% (GMT:19.44 Eu/mL, 95%CI:16.42-23.03). The most common systemic complication after vaccination was fever. Also, one infant cried for more than 3 hours after the second dose. Other serious side effects were not observed. Conclusion: The Pentavalent vaccine used in Iran can cause adequate antibody response against diphtheria, tetanus, pertussis, Hib and hepatitis B in most cases with minimal side effects. The immunogenicity of this vaccine is significantly lower for pertussis. In this study, no severe complication leading to contraindication to subsequent injections was reported. So, the present policy in replacing triple DTP vaccine with Pentavalent vaccine should be continued in Iran.
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