• Clinical and Experimental Vaccine Research
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• 제11권1호
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• pp.72-81
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• 2022

Purpose: This study aims to compare protection against diphtheria and tetanus conferred on the mother and the neonate before and after maternal vaccination against tetanus, diphtheria, and acellular pertussis (Tdap), transfer of antibodies, and the variables that could impact on the protection. Materials and Methods: The study followed a cohort of 200 pregnant women from a region in Colombia, contacted during prenatal control before vaccination and upon delivery. The work determined immunoglobulin G antibodies against diphtheria and tetanus of pregnant women and umbilical cord. The proportion of protection, the geometric mean of the concentration, and the transfer of maternal antibodies were calculated. The protection profile of the pregnant women was explored by using multiple correspondence analysis. Results: The concentration of antibodies against diphtheria was significant before and after vaccination of the pregnant women (p=0.000) with proportions of 85.0% and 97.5%, respectively, and of 98.6% in the umbilical cord, with significant antibody correlation (Spearman's coefficient=0.668, p=0.01). Sero-protection against tetanus before vaccination was at 71.0%, after at 92.6%, and in the umbilical cord at 95.9%, with significant antibody concentration before and after vaccination (p=0.000) and antibody correlation (Spearman's coefficient=0.936, p=0.01). Sero-protection was higher when the pregnant women were vaccine 8 to 11 weeks before delivery. Unprotected pregnant women were those not vaccinated during pregnancy. Conclusion: The high proportion of protection against diphtheria and tetanus and the placental transfer support the need to promote maternal immunization with Tdap.

• Journal of Microbiology and Biotechnology
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• 제13권3호
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• pp.338-343
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• 2003

Various factors, such as the adsorption pH, adjuvant dose, and adjuvant age, which affect the adsorption degree and immunogenicity of an antigen, were investigated. In addition, the effect of pH, antigen content, and adjuvant content on immunogenicity was also studied through animal experiments. Within the ranges studied, a low pH for adsorption, freshly preformed gel, and low pH formulation for the combined DTwP-HepB vaccine were preferrable for the adsorption of the antigens. In addition, a higher DT content was found to have a positive effect on the HBsAg immunogenicity in the combined vaccine. Accordingly, considering the factors affecting the adsorption rate and immunogenicity of the antigens, a novel DTwP-HepB vaccine (40 Lf/ml of diphtheria toxoid, 15 Lf/ml of tetanus toxoid, 20 OU/ml of detoxified whole cell pertussis, $24\;\mu\textrm{g}$ of HBsAg, $24\;\mu\textrm{g}\;Al/ml\;of \;Al(OH)_3\;gel,\;776\;\mu\textrm{g}\; Al/ml\;of\;AIPO_4\;gel$, and pH 7.1) was developed, whose immunogenicity was comparable to the case of administrating, separately and simultaneously, a combined DTwP vaccine (40 Lf/ml of diphtheria toxoid, 15 Lf/ml of tetanus toxoid, 20 OU/ml of detoxified whole cell pertussis, $300\;\mu\textrm{g}\;Al/ml\;of\; AIPO_4\;gel$, and pH 7.1) and mono HepB vaccine [$Hepavax^{\circledR},\;24\;\mu\textrm{g}/ml$ of HBsAg and $500\;\mu\textrm{g}\;Al/ml\;of\;Al(OH)_3\;gel$], which satisfies the potency criteria of the K-FDA for a combined DTwP vaccine and mono HepB vaccine.

• Clinical and Experimental Pediatrics
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• 제64권12호
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• pp.602-607
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• 2021

In April 2020, the Ministry of Food and Drug Safety licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugated to tetanus protein, and hepatitis B (HepB) (recombinant DNA) vaccine, DTaP-IPV-Hib-HepB (Hexaxim, Sanofi Pasteur), for use as a 3-dose primary series in infants aged 2, 4, and 6 months. The DTaP-IPV-Hib-HepB vaccine is highly immunogenic and safe and provides a long-term immune response based on studies performed in a variety of settings in many countries, including Korea. This report summarizes the Committee on Infectious Diseases of the Korean Pediatric Society guidelines for the use of this newly introduced hexavalent combination vaccine.

• Clinical and Experimental Vaccine Research
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• 제12권3호
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• pp.232-239
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• 2023

Purpose: The purpose of this study was to compare the antigenic potency and stability of tetanus and diphtheria (Td) vaccines when combined with aluminum phosphate (AlPO₄) and liposome adjuvants. Materials and Methods: In vitro and in vivo analyses were conducted using the single radial immunodiffusion method and sodium dodecyl sulfate-polyacrylamide gel electrophoresis. The Td vaccines were prepared with AlPO₄ adsorption and liposome-mediated delivery, and protein antigens were characterized using these methods. Results: The results revealed that the liposome-mediated Td vaccines exhibited higher immunogenicity compared to the AlPO₄-adsorbed Td vaccines. Additionally, the liposome-mediated Td vaccines demonstrated higher stability as native antigens. Conclusion: This study highlights the importance of utilizing liposome adjuvants in vaccine development. The liposome-mediated Td vaccines showed enhanced immunogenicity and stability, making them a promising approach for improving vaccine efficacy. Understanding and optimizing adjuvant strategies can contribute to the development of effective vaccines against various diseases.

• Journal of Microbiology and Biotechnology
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• 제12권5호
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• pp.787-792
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• 2002

When developing a combined DTaP-HepB vaccine, toxicity and HBsAg immunogenicity are both important considerations. Thus, for a combined DTaP-HepB vaccine with a low toxicity, the effect of the DTaP content and $Al(OH)_3$, gel concentration on the vaccine toxicity was investigated. Within the range studied, the higher the concentrations, the higher the vaccine toxicity. The importance of the tetanus toxoid content in the combined DTaP-HepB vaccine was also revealed. A higher concentration of the tetanus toxoid was found to have a negative effect on the stability of the HBsAg immunogenicity in the combined vaccine. Accordingly, considering the factors affecting toxicity and HBsAg immunogenicity, a novel DTaP-HepB vaccine (30 Lf/ml of diphtheria toxoid, 5 Lf/ml of tetanus toxoid, 10 $\mu\textrm{g}$ PN/ml of acellular pertussis, 24 $\mu\textrm{g}$/ml of HBsAg, and 500 $\mu\textrm{g}$ Al/ml of $Al(OH)_3$ gel) was developed. It has a low toxicity and a stable HBsAg immunogenicity and also satisfies the potency criteria of K-FDA for a combined DTaP vaccine.

• Pediatric Infection and Vaccine
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• 제25권3호
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• pp.141-147
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• 2018

목적: 임신 중 tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) 접종의 효과 및 안전성에도 불구하고, 아직 국내 임신 중 Tdap 접종률은 낮다. 이에 저자들은 임신 중 Tdap 접종에 대한 임부들의 인식, 태도 및 행동에 대한 조사를 하였다. 방법: 본 연구는 서울 및 경기 소재 대학병원 산부인과를 방문한 임부를 대상으로 개별적인 설문지를 통해 임신 중 Tdap 접종에 대한 인식, 태도 및 행동을 수집한 단면 설문조사다. 결과: 총 184명의 임부들이 설문지 작성을 완료하였다. 이 중 158명(86%)의 임부들은 의사로부터 백일해 및 Tdap 백신에 대한 정보를 안내 받지 못했고, 166명(90%)의 임부들은 임신 중 Tdap 접종의 필요성을 알지 못했다. 현 임신기간 중 Tdap 접종을 하지 않을 것이라고 답한 임부 중 7%만이 백일해 및 백신에 대한 이해를 묻는 5문항 중 3문항 이상 올바르게 답하였다. 로지스틱 회귀분석에서 의사의 추천(adjusted odds ratio [OR], 236.2; 95% confidence interval [CI], 12.6-4,432), 백신이 효과적이라는 믿음(adjusted OR, 40.21; 95% CI, 2.35-687.7), 백신이 안전하다는 믿음(adjusted OR, 19.83; 95% CI, 1.54-255.9) 등이 Tdap 접종을 결정하는데 유의하게 중요한 요인이었다. 결론: 대부분의 임부들이 Tdap 접종에 대하여 적절하게 안내를 받지 못하거나, 추천받지 못하는 것으로 보인다. 임부들의 Tdap 접종률을 향상시키는 데에 의료기관 종사자에 의해 제공되는 정보가 매우 중요하다.

• Clinical and Experimental Vaccine Research
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• 제13권2호
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• pp.155-165
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• 2024

Purpose: Pertussis bacteria have many pathogenic and virulent antigens and severe adverse reactions have occurred when using inactivated whole-cell pertussis vaccines. Therefore, inactivated acellular pertussis (aP) vaccines and genetically detoxified recombinant pertussis (rP) vaccines are being developed. The aim of this study was to assess the safety profile of a novel rP vaccine under development in comparison to commercial diphtheria-tetanus-acellular pertussis (DTaP) vaccines. Materials and Methods: The two positive control DTaP vaccines (two- and tri-components aP vaccines) and two experimental recombinant DTaP (rDTaP) vaccine (two- and tri-components aP vaccines adsorbed to either aluminum hydroxide or purified oat beta-glucan) were used. Temperature histamine sensitization test (HIST), indirect Chinese hamster ovary (CHO) cell cluster assay, mouse-weight-gain (MWG) test, leukocytosis promoting (LP) test, and intramuscular inflammatory cytokine assay of the injection site performed for safety assessments. Results: HIST results showed absence of residual pertussis toxin (PTx) in both control and experimental DTaP vaccine groups, whereas in groups immunized with tri-components vaccines, the experimental tri-components rDTaP absorbed to alum showed an ultra-small amount of 0.0066 IU/mL. CHO cell clustering was observed from 4 IU/mL in all groups. LP tests showed that neutrophils and lymphocytes were in the normal range in all groups immunized with the two components vaccine. However, in the tri-components control DTaP vaccine group, as well as two- and tri-components rDTaP with beta-glucan group, a higher monocyte count was observed 3 days after vaccination, although less than 2 times the normal range. In the MWG test, both groups showed changes less than 20% in body temperature and body weight before the after the final immunizations. Inflammatory cytokines within the muscle at the injection site on day 3 after intramuscular injection revealed no significant response in all groups. Conclusion: There were no findings associated with residual PTx, and no significant differences in both local and systemic adverse reactions in the novel rDTaP vaccine compared to existing available DTaP vaccines. The results suggest that the novel rDTaP vaccine is safe.

• Clinical and Experimental Pediatrics
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• 제50권4호
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• pp.355-362
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• 2007

목 적 : 3가 항원 DTaP 백신을 3회 기초 접종 받은 건강한 국내 영아에서 면역원성 및 안전성을 평가하고자 하였다. 방 법 : 2004년 4월부터 2005년 4월까지 5개 연구 참여 대학병원에서 제태기간 32주 이상에서 태어난 건강한 영아에게 생후 2, 4, 6개월에 3가 항원 DTaP 백신($Infanrix^{(R)}$)을 대퇴부 전외측에 접종하여 접종 전 혈청과 3차 접종 1개월 후 혈청에서 디프테리아, 파상풍, PT, FHA, PRN 항원에 대한 항체를 측정하여 면역원성을 평가하였고, 접종 후 3일 내에 발생이 예상되는 국소 및 전신 이상반응을 적극 관찰하였고 3주내에 발생한 모든 이상반응을 관찰하여 안전성 평가를 실시하였다. 한편, 2가 항원 DTaP 백신을 접종 받은 14명을 대조군으로 설정하여 연구군과 동일한 방법으로 면역원성을 평가하여 비교하였다. 결 과 : 60명에서 실시된 연구군의 면역원성 평가에서 디프테리아, 파상풍, FHA, PRN 항원에 대한 항체 양전율은 100%이었고, PT 항원에 대한 항체 양전율은 98.3%이었다. 한편 대조군에서 디프테리아, 파상풍, PT, FHA 항원에 대한 항체 양전율은 100%이었으나 PRN 항원에 대한 항체 양전율은 50%이었다. 147명에서 확인된 이상반응 평가에서 연구 기간동안 연구 백신과 인과관계가 있는 중증 이상반응은 없었고, 3일 내에 특이한 치료 및 처치가 없이 자연 소멸되는 국소 및 전신 이상반응만 관찰되었으며 접종 차수별 이상반응의 증가도 없었다. 결 론 : 이상의 결과를 볼 때에 3가 항원 DTaP 백신($Infanrix^{(R)}$)은 국내 영아 기초 접종에 유효한 백신임을 확인할 수 있었고, 국내에서 가장 많이 사용되고 있는 2가 DTaP 백신에 비해 PRN항원에 대한 항체의 면역원성이 높은 이점이 있음을 확인하였다. 그러나 향후 더욱 많은 대상을 통한 연구가 이루어져 이런 결과를 재입증하여야 할 것이고, 추가 접종에 대한 동일한 연구도 요구된다.

• Clinical and Experimental Pediatrics
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• 제51권11호
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• pp.1185-1190
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• 2008

목 적: 11-12세 연령에 Td 백신 1차 추가접종을 하는 방법에 대한 면역원성과 안전성을 평가하기 위해 연구를 계획하였다. 방 법: 2006년 8월부터 2007년 4월까지 연구병원 소아청소년과 외래에 Td 백신 접종을 받기 위해 내원한 11-12세의 소아를 대상으로 하였다. 면역원성을 평가하기 위하여 접종 전 및 접종 4주 후에 혈액을 채취하여 디프테리아 및 파상풍에 대한 항독소 항체가를 측정하였고 이상반응을 평가하기 위해 관찰 일지에 국소 및 전신 이상반응을 기록하였다. 결 과: 총 183명이 연구에 참여하였고 이들의 평균 연령은 $11.40{\pm}0.51$세이었다. Td 백신 접종 전후의 GMC는 디프테리아에 대해서는 10배, 파상풍에 대해서는 26배 이상 증가하였고, 접종 후 디프테리아와 파상풍에 대한 항체 양전율(항체가 ${\geq}0.1IU/mL$ 기준)은 100%이었다. 디프테리아의 접종 전 항체가가 0.1 IU/mL 이상인 피험자는 142명(77.6%)이었고 접종 후 항체가가 1.0 IU/mL 이상인 피험자는 174명(95.1%)이었다. 파상풍의 접종 전 항체가가 0.1 IU/mL 이상인 피험자는 146명(79.8%)이었고 접종 후 항체가가 1.0 IU/mL 이상인 피험자는 181명(98.9%)이었다. 접종 후 국소 이상반응이 73.8%, 전신 이상반응은 37.2%에서 발생하였으나 대부분 3일 이내 소실되었다. 결 론: 매우 높은 면역원성과 심하지 않은 이상반응을 고려할 때, Td 백신의 접종을 11-12세 시행하는 것은 디프테리아와 파상풍에 대한 가장 경제적인 방어 수단이며, 접종 순응도를 효율적으로 높일 수 있는 방법이다.

• Clinical and Experimental Pediatrics
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• 제62권7호
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• pp.252-256
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• 2019

The Committee on Infectious Diseases of the Korean Pediatric Society recommended immunization schedule for children and adolescents aged 18 years or younger in the 9th (2018) edition of Immunization guideline. This report provides the revised recommendations made by the committee and summarizes several changes from the 2015 guideline. National immunization program (NIP) launched a human papillomavirus (HPV) immunization for girls aged 12 years in 2016. NIP has also expanded age indication for inactivated influenza vaccine (IIV) to 12 years of age in the 2018-2019 season. Quadrivalent IIVs with a full dose (0.5 mL) are approved for all children of 6 months or older. Recommendations of live attenuated influenza vaccine were removed. For inactivated Japanese encephalitis vaccine, first 2 doses are considered as the primary series. Recommendations for use of newly introduced vaccines (diphtheria-tetanus-acellular pertussis/inactivated poliovirus/Haemophilus influenzae type b, 9-valent HPV, new varicella vaccine, new quadrivalent IIV, and attenuated oral typhoid vaccine) were added. Lastly, monitoring system for adverse events following immunization was updated. Other changes can be found in the 9th edition of Immunization guideline in detail.