title: Immunogenicity and reactogenicity of two diphtheria-tetanus-whole cell pertussis vaccines in Iranian pre-school children, a randomized controlled trial.
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.
authors: Monoclonal 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.
authors: Saeed
authors: S
authors: Zarei
authors: Mahmood
authors: M
authors: Jeddi-Tehrani
authors: Mohammad
authors: M
authors: Mehdi Akhondi
authors: Hojjat
authors: H
authors: Zeraati
authors: Amir Ali
authors: AA
authors: Ferydonfar
authors: Jalaledin
authors: J
authors: Nasernia
authors: Banafsheh
authors: B
authors: Tavangar
authors: Fazel
authors: F
authors: Shokri
mesh_terms: D000907:Antibodies, Bacterial; D002648:Child; D002675:Child, Preschool; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D007492:Iran; D008297:Male; D010146:Pain / Q000139:chemically induced / Q000453:epidemiology; D011446:Prospective Studies
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine
keywords: Diphtheria-tetanus-pertussis vaccine; enzyme-linked immunosorbent assay; immunogenicity; randomized controlled trial; reactogenicity; vaccination