• 제목/요약/키워드: vaccine safety

검색결과 190건 처리시간 0.029초

건강한 소아와 청소년에 대한 A형 간염(VAQTATM) 2회 접종시 면역원성 및 안전성에 대한 연구 (Immunogenicity and Safety of a Two Doses of Hepatitis A Vaccine(VAQTATM) in Healthy Children and Adolescents)

  • 이진수;박지호;손영모
    • Pediatric Infection and Vaccine
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    • 제8권2호
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    • pp.160-167
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    • 2001
  • 목 적 : A형 간염의 항체보유율의 감소와 이에 따른 질병 부담이 커진 최근, 건강한 2~17세 소아, 청소년에게 2회에 걸친 A형 간염 백신 접종 후 면역원성과 안전성 및 내약성을 조사하여 기본 접종으로의 적합성을 알아보고자 하였다. 방 법 : 총 110명의 대상자를 통한 공개, 단일 기관 임상시험으로서, 대상에 적합한 건강한 소아, 청소년에게 24주 간격으로 2회 A형 간염($VAQTA^{TM}$) 백신을 투여하였다. 2차 접종 4주 후에 modified HAVAB 검사법으로 면역원성을 평가하였고, 매회 접종마다 30분간의 즉각적인 알레르기 반응, 4일간의 발열 반응, 14일간의 국소, 전신 이상반응을 평가하였다. 결 과 : 총 110명 중 대상에 적합한 102명이 1차 접종을, 100명이 2차 접종을 완료하였다. 채혈은 90명에서 실시되었고 2차 접종 4주 후 100%의 면역원성을 나타냈다. 기하평균은 Per-protocol analysis에서 7,991.1 mIU/mL이었다. 이상반응으로는 국소 이상 반응이 2.9%로 주사 부위의 통증이 2%, 소양감이 1%였다. 전신 이상반응은 4.2%였으며 피로감이 가장 많아 2.9%였고, 구토와 구역, 무력감 등이 관찰되었다. 아나필락시스나 중대한 이상반응은 없이 모두 경미하고 일시적이었다. 결 론 : 소아용 A형 간염 백신($VAQTA^{TM}$)을 6개월 간격으로 2회 접종 후 100% 면역원성 관찰하였으며 접종자에서 우수한 내약성과 안전성을 확인하였다. 최근 성인에서 A형 간염의 중요성이 강조되고 있는 상황에서 소아에서 적극적인 예방접종의 필요성이 검토되어야 한다.

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구제역 백신의 국가출하승인검정을 통한 품질 평가 (Evaluation for foot-and-mouth disease vaccines in South Korea by the test for national lot release)

  • 김문현;서민구;이향심;김지연;김지예;김용상;김연희
    • 한국동물위생학회지
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    • 제42권4호
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    • pp.285-288
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    • 2019
  • Foot-and-mouth disease (FMD) causes economic problems in livestock industry because of fast spread and inducing low productivity. FMD outbreaks occurred in South Korea over the period from 2000 to 2019. Vaccination is the most practical and effective means of controlling or preventing these outbreaks, and a national vaccination policy has been in place for all FMD-susceptible animals since 2010. To prevent and control of FMD, South Korea has been using vaccines imported from the United Kingdom, Argentina, and Russia. The Animal and Plant Quarantine Agency of South Korea oversees continuous quality control of imported FMD vaccines. FMD vaccines were evaluated characteristics, sterility, pH, inactivation, safety, potency test by Korean FMD vaccine standard assay (Test for National Lot Release). The 6 company vaccines (A~F) were used Test for National Lot Release by each method. We evaluated quality of each FMD vaccine from 2015 to 2019. All batch of vaccine showed good quality control and were passed the Test for National Lot Release. The serotypes of vaccine are increasingly changing to multiple vaccine because the FMD was outbreak by various serotype virus in South Korea. Furthermore, this data may be useful as a basis for ensuring the quality of FMD vaccines and for base data to manage them. Additional study is required to simple approach for rapid evaluation of quality and antigen content identification in vaccines.

바이러스 질병 예방을 위한 식물 경구 백신 연구 동향 (Recent Studies of Edible Plant Vaccine for Prophylactic Medicine against Virus-mediated Diseases)

  • 한범수;박종석;김형국;하선화;조강진;김용환;김종범
    • Journal of Plant Biotechnology
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    • 제31권2호
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    • pp.151-161
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    • 2004
  • Transgenic plants have been studied as delivery system for edible vaccine against various diseases. Edible plant vaccines have several potential advantages as follows: an inexpensive source of antigen, easy administration, reduced need for medical personnel, economical to mass produce and easy transport, heat-stable vaccine without refrigerator, generation of systemic and mucosal immunity and safe antigen without fetal animal-virus contaminants. The amount of recombinant antigens in transgenic plants ranged from 0.002 to 0.8% in total soluble protein, depending on promoters for the expression of interested genes and plants to be used for transformation. Throughout the last decade, edible plant vaccine made notable progresses that protect from challenges against virus or bacteria. However edible plant vaccines have still problems that could be solved. First, the strong promoter or inducible promoter or strategy of protein targeting could be solved to improve the low expression of antigens in transgenic plants. Second, the transformation technique of target plant should be developed to be able to eat uncooked. Third, marker-free vector could be constructed to be more safety. In this review we describe advances of edible plant vaccines, focusing on the yields depending on plants/promoters employed and the results of animal/clinical trials, and consider further research for the development of a new plant-derived vaccine.

An Engineered Outer Membrane-Defective Escherichia coli Secreting Protective Antigens against Streptococcus suis via the Twin-Arginine Translocation Pathway as a Vaccine

  • Li, Wenyu;Yin, Fan;Bu, Zixuan;Liu, Yuying;Zhang, Yongqing;Chen, Xiabing;Li, Shaowen;Li, Lu;Zhou, Rui;Huang, Qi
    • Journal of Microbiology and Biotechnology
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    • 제32권3호
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    • pp.278-286
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    • 2022
  • Live bacterial vector vaccines are one of the most promising vaccine types and have the advantages of low cost, flexibility, and good safety. Meanwhile, protein secretion systems have been reported as useful tools to facilitate the release of heterologous antigen proteins from bacterial vectors. The twin-arginine translocation (Tat) system is an important protein export system that transports fully folded proteins in a signal peptide-dependent manner. In this study, we constructed a live vector vaccine using an engineered commensal Escherichia coli strain in which amiA and amiC genes were deleted, resulting in a leaky outer membrane that allows the release of periplasmic proteins to the extracellular environment. The protective antigen proteins SLY, enolase, and Sbp against Streptococcus suis were targeted to the Tat pathway by fusing a Tat signal peptide. Our results showed that by exploiting the Tat pathway and the outer membrane-defective E. coli strain, the antigen proteins were successfully secreted. The strains secreting the antigen proteins were used to vaccinate mice. After S. suis challenge, the vaccinated group showed significantly higher survival and milder clinical symptoms compared with the vector group. Further analysis showed that the mice in the vaccinated group had lower burdens of bacteria load and slighter pathological changes. Our study reports a novel live bacterial vector vaccine that uses the Tat system and provides a new alternative for developing S. suis vaccine.

New typhoid vaccine using sponge-like reduced protocol: development and evaluation

  • Rehab Bahy;Asmaa Gaber;Hamdallah Zedan;Mona Mabrook
    • Clinical and Experimental Vaccine Research
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    • 제12권1호
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    • pp.70-76
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    • 2023
  • Purpose: Typhoid remains a major health problem, especially in the developing world. Furthermore, the emergence of multidrug-resistant and extensively drug-resistant strains of Salmonella typhi added a sense of urgency to develop more effective typhoid vaccines, one of which is bacterial ghosts (BGs), prepared by both genetic and chemical means. The chemical method includes incubation with numerous agents for a short time at their minimum inhibitory or minimum growth concentrations. This study included the preparation of BGs by a sponge-like reduced protocol (SLRP). Materials and Methods: Critical concentrations of sodium dodecyl sulfate, NaOH, and H2O2 were used. Moreover, high-quality BGs were visualized by scanning electron microscope (SEM). Subculturing was used to confirm the absence of vital cells. Besides, the concentrations of the released DNA and protein were estimated spectrophotometrically. In addition, the integrity of cells was proved by visualizing Gram-stained cells using a light microscope. Furthermore, a comparison between the immunogenicity and safety of the prepared vaccine and the available whole-cell killed vaccine was established. Results: Improved preparation of high-quality BGs of S. typhi, visualized by SEM, revealed punctured cells with intact outer shells. Moreover, the absence of vital cells was confirmed by subculturing. At the same time, the release of respective amounts of proteins and DNA is another evidence of BGs' production. Additionally, the challenge test provided evidence that the prepared BGs are immunogenic and have the same efficacy as the whole cell vaccine. Conclusion: The SLRP provided a simple, economical, and feasible method for BGs preparation.

면역저하환자에서 인플루엔자백신의 면역원성 평가 (Assessment of Influenza Vaccine Immunogenicity in Immunocompromized Host During 2009 Influenza Season: A Single Institution Experience)

  • 김동환;송봉섭;이준아;김동호
    • Pediatric Infection and Vaccine
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    • 제19권1호
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    • pp.1-11
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    • 2012
  • 목 적 : 인플루엔자는 소아암 환자에게 이환율과 사망률이 높은 질환이나 소아암 환자에 대한 예방 접종률은 낮은 상태이다. 본 연구에서는 소아암 환자를 대상으로 인플루엔자 예방접종의 면역원성과 부작용에 대한 평가를 시행하였다. 방 법 : 2009년 10월부터 12월까지 원자력의학원에서 인플루엔자 예방접종(SK influenza IX vaccine$^{(R)}$)을 받은 25명의 소아암 환자를 대상으로 연구를 시행했다. 예방접종일과 접종 후 30일 뒤 2회에 걸쳐 채혈하였고 혈구응집억제 항체가를 측정하였다. 백신의 면역원성은 접종 전과 접종 후 30일의 혈구응집억제 항체가 1:40 이상인 피험자 비율, 접종 후 30일의 항체 양전율, 접종 전과 접종 후 30일 사이의 GMT 증가 배수로 평가하였다. 결 과 : 본 연구대상자 중에서 심각한 예방접종관련 부작용을 경험한 대상자는 없었다. 접종 후 혈구응집억제 항체가 1:40 이상을 보인 피험자의 비율은 H1N1 항원에 대해 68%, H3N2 항원에 대해 40%, B 항원에 대해 36%였다. 항체양전율은 H1N1 항원에 대해 12%, H3N2 항원에 대해 16%, B 항원에 대해 20%였다. GMT 증가 배수는 H1N1 항원에 대해 0.9, H3N2 항원에 대해 1.2, B 항원에 대해 1.8이었다. 결 론 : 본 연구의 대상자들은 인플루엔자 백신에 대해 제한적인 면역반응을 보였으나 일부 대상자들에게서 항체 양전이 나타났고 심각한 예방접종관련 부작용이 없었던 점을 고려할 때 소아암환자를 대상으로 매년 정기적인 인플루엔자 예방접종이 추천된다.

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Protective Immunity Induced by Systemic and Mucosal Delivery of DNA Vaccine Expressing Glycoprotein B of Pseudorabies Virus

  • Yoon, Hyun-A;Han, Young-Woo;Aleyas, Abi George;George, June Abi;Kim, Seon-Ju;Kim, Hye-Kyung;Song, Hee-Jong;Cho, Jeong-Gon;Eo, Seong-Kug
    • Journal of Microbiology and Biotechnology
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    • 제18권3호
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    • pp.591-599
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    • 2008
  • A murine model immunized by systemic and mucosal delivery of plasmid DNA vaccine expressing glycoprotein B (pCIgB) of pseudorabies virus (PrV) was used to evaluate both the nature of the induced immunity and protection against a virulent virus. With regard to systemic delivery, the intramuscular (i.m.) immunization with pCIgB induced strong PrV-specific IgG responses in serum but was inefficient in generating a mucosal IgA response. Mucosal delivery through intranasal (i.n.) immunization of pCIgB induced both systemic and mucosal immunity at the distal mucosal site. However, the levels of systemic immunity induced by i.n. immunization were less than those induced by i.m. immunization. Moreover, i.n. genetic transfer of pCIgB appeared to induce Th2-biased immunity compared with systemic delivery, as judged by the ratio of PrV-specific IgG isotypes and Th1- and Th2-type cytokines produced by stimulated T cells. Moreover, the immunity induced by i.n. immunization did not provide effective protection against i.n. challenge of a virulent PrV strain, whereas i.m. immunization produced resistance to viral infection. Therefore, although i.n. immunization was a useful route for inducing mucosal immunity at the virus entry site, i.n. immunization did not provide effective protection against the lethal infection of PrV.

렙토스피라 백신의 면역성 및 안전성에 관한 임상적 연구 (Clinical trial of leptospires vaccine on it immunogenicity and safety)

  • 윤형렬;김정순;허용
    • Journal of Preventive Medicine and Public Health
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    • 제23권1호
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    • pp.57-64
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    • 1990
  • Since the reservoir of leptospires organism is consisted of a broad spectrum of animals, the best method of prevention is vaccination. The clinical trial of leptospires vaccine conducted on human volunteer for its immunogenicity and safety. Summarized results are as following : 1. The Oral temperature among vaccinated group ranged from $36.7{\pm}0.46^{\circ}C\;to\;37.0{\pm}0.34^{\circ}C$, while in placebo injected group it ranged from $36.4{\pm}0.46^{\circ}C\;to\;36.7{\pm}0.53^{\circ}C$. There was no association between vaccination and fever (p>0.05) 2. Mild local reactions revealed in vaccinees were swelling (50-75% ), Redness($75{\sim}90%$), and induration ($25{\sim}40%$). Placebo injected group revealed only redness in 12.5% in 1st injection and 37.5% in second injection. The duration local reactions on injection site for th vaccinees and place groups disappeared within 48 hours. 3. Generalized Symptoms complained by the vaccinees were myalgia (25%), back pain(15%), headache (15%), pruritus(15%), and abdominal pain(10%), whereas placebo group complained of headache (25%), myalgia(12.5%), back pain(12.5%), pain in eyes(12.5%), abdominal pain(12.5%) pruritus (12.5%) and nausea(12.5%). 4. The serological test(MAT) of vaccinees showed geometric mean antibody titer as follows : a. L. icterohemorrhagiae lai 1 week after 1st vaccination : 22.45 1 week after 2nd vaccination : 111.23 3 week after 2nd vaccination : 266.64 b. L. canicola canicola 1 week after 1st vaccination : 24.62 1 week after 2nd vaccination : 123.92 3 week after 2nd vaccination : 276.55 c. L. icterohemorrhagiae copenhageni 1 week after 1st vaccination : 28.28 1 week after 2nd vaccination : 128.55 3 week after 2nd vaccination : 247.88 Whereas all of the place injected group showed below 1:20 titers. The sero-conversion rate of vaccinees were 100 percent.

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Modulation of Humoral and Cell-Mediated Immunity Against Avian Influenza and Newcastle Disease Vaccines by Oral Administration of Salmonella enterica Serovar Typhimurium Expressing Chicken Interleukin-18

  • Rahman, Md Masudur;Uyangaa, Erdenebileg;Eo, Seong Kug
    • IMMUNE NETWORK
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    • 제13권1호
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    • pp.34-41
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    • 2013
  • Interleukin-18 (IL-18) has been known to induce interferon-${\gamma}$ (IFN-${\gamma}$) production and promote Th1 immunity. Although mammalian IL-18 has been characterized in great detail, the properties and application of chicken IL-18 remain largely uninvestigated as of yet. In this study, we evaluated the immunomodulatory properties of Salmonella enterica serovar Typhimurium expressing chicken interleukin-18 (chIL-18) on immune responses induced by avian influenza (AI) and Newcastle disease (ND) vaccines. After oral administration of S. enterica serovar Typhimurium expressing chIL-18, chickens were vaccinated intramuscularly with the recommended dose of either inactivated AI H9N2 vaccine or ND (B1 strain) vaccine. Chickens receiving a primary vaccination were boosted using the same protocol 7 days later. Humoral and cell-mediated immune responses were evaluated in terms of HI antibody titers and proliferation and mRNA expression of IFN-${\gamma}$ and IL-4 of peripheral blood mononuclear cells (PBMC) in response to specific antigen stimulation. According to our results, oral administration of S. enterica serovar Typhimurium expressing chIL-18 induced enhanced humoral and Th1-biased cell-mediated immunity against AI and ND vaccines, compared to that of chickens received S. enterica serovar Typhimurium harboring empty vector. Therefore, we conclude that our proposed vaccination regimen using inactivated AI and ND viruses along with oral administration of S. enterica serovar Typhimurium expressing chIL-18 may provide a novel approach in protecting chicken from currently circulating AI and ND virus strains.

Efficacy of recombinant enolase as a candidate vaccine against Haemaphysalis longicornis tick infestation in mice

  • Md. Samiul Haque;Mohammad Saiful Islam;Myung-Jo You
    • Parasites, Hosts and Diseases
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    • 제61권4호
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    • pp.439-448
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    • 2023
  • Tick infestation causes a significant threat to human and animal health, requiring effective immunological control methods. This study aimed to investigate the potential of recombinant Haemaphysalis longicornis enolase protein for tick vaccine development. The exact mechanism of the recently identified enolase protein from the H. longicornis Jeju strain remains poorly understood. Enolase plays a crucial role in glycolysis, the metabolic process that converts glucose into energy, and is essential for the motility, adhesion, invasion, growth, and differentiation of ticks. In this study, mice were immunized with recombinant enolase, and polyclonal antibodies were generated. Western blot analysis confirmed the specific recognition of enolase by the antiserum. The effects of immunization on tick feeding and attachment were assessed. Adult ticks attached to the recombinant enolase-immunized mice demonstrated longer attachment time, increased bloodsucking abilities, and lower engorgement weight than the controls. The nymphs and larvae had a reduced attachment rate and low engorgement rate compared to the controls. Mice immunized with recombinant enolase expressed in Escherichia coli displayed 90% efficacy in preventing tick infestation. The glycolytic nature of enolase and its involvement in crucial physiological processes makes it an attractive target for disrupting tick survival and disease transmission. Polyclonal antibodies recognize enolase and significantly reduce attachment rates, tick feeding, and engorgement. Our findings indicate that recombinant enolase may be a valuable vaccine candidate for H. longicornis infection in experimental murine model.