• Title/Summary/Keyword: Vaccine immunogenicity

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Development of Vaccine Delivery System and Challenges (백신 전달기술 개발 동향과 과제)

  • Jung, Hyung-Il;Kim, Jung-Dong;Kim, Mi-Roo;Dangol, Manita
    • KSBB Journal
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    • v.25 no.6
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    • pp.497-506
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    • 2010
  • Vaccine is a protective clinical measure capable of persuading immune system against infectious agents. Vaccine can be categorized as live attenuated and inactivated. Live attenuated vaccines activate immunity similar to natural infection by replicating living organisms whereas inactivated vaccines are either whole cell vaccines, eliciting immune response by killed organisms,or subunit vaccines, stimulating immunity by non-replicating sub cellular parts. The components of vaccine play a critical role in deciding the immune response mediated by the vaccine. The innate immune responds against the antigen component. Adjuvants represent an importantcomponent of vaccine for enhancing the immunogenicity of the antigens. Subunit vaccines with isolated fractions of killed and recombinant antigens are mostly co-administered with adjuvants. The delivery system of the vaccine is another essential component to ensurethat vaccine is delivered to the right target with right dosage form. Furthermore, vaccine delivery system ensures that the desired immune response is achieved by manipulating the optimal interaction of vaccine and adjuvantwith the immune cell. The aforementioned components along with routes of administration of vaccine are the key elements of a successful vaccination procedure. Vaccines can be administered either orally or by parenteral routes. Many groups had made remarkable efforts for the development of new vaccine and delivery system. The emergence of new vaccine delivery system may lead to pursue the immunization goals with better clinical practices.

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

  • Yoon, Hyeong-Ryeol;Kim, Jeong-Soon;Heo, Yong
    • Journal of Preventive Medicine and Public Health
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    • v.23 no.1 s.29
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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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Validation of a Multiplexed Opsonophagocytic Assay for 11 Additional Pneumococcal Serotypes and Its Application to Functional Antibody Evaluation Induced by Pneumococcal Polysaccharide Vaccine

  • Cha, Jihei;Kim, Han Wool;Lee, Ji Hyen;Lee, Soyoung;Kim, Kyung-Hyo
    • Journal of Korean Medical Science
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    • v.33 no.51
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    • pp.340.1-340.14
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    • 2018
  • Background: Various pneumococcal vaccines have been evaluated for immunogenicity by opsonophagocytic assay (OPA). A multiplexed OPA (MOPA) for 13 pneumococcal serotypes was developed by Nahm and Burton, and expanded to 26 serotypes in 2012. The development of new conjugate vaccines with increased valence has necessitated expanded MOPAs to include these additional serotypes. In this study, we validated this expanded MOPA platform and applied to measure antibodies against 11 additional serotypes (2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F) in human sera. Methods: All materials, including serum, complement, bacterial master stocks, and HL-60 cells, were evaluated for assay optimization. Following optimization, the assay was validated for accuracy, specificity, and intra- and inter-assay precision with sera from adult donors following standard protocols. The assay was applied to evaluate functional antibodies of 42 sera immunized with 23-valent pneumococcal polysaccharide vaccine (PPV23). Results: The expanded MOPA platform was specific for all serotypes, with the exception of serotype 20. The assay results were highly correlated with those obtained from single-serotype OPA, indicating acceptable accuracy. The coefficients of variation were 7%-24% and 13%-39% in tests of intra- and inter-assay precision, respectively, using three quality-control samples. A MOPA that included 11 additional serotypes in the PPV23 was established and validated with respect to accuracy, specificity, and precision. The opsonic indices of immune sera were obtained using this validated assay. Conclusion: The expanded MOPA will be useful for evaluation of the immunogenicity of PPV23 and future conjugate vaccine formulations.

Expression of FMD virus-like particles in yeast Hansenula polymorpha and immunogenicity of combine with CpG and aluminum adjuvant

  • Jianhui Zhang;Jun Ge;Juyin Li;Jianqiang Li;Yong Zhang;Yinghui Shi;Jiaojiao Sun;Qiongjin Wang;Xiaobo Zhang;Xingxu Zhao
    • Journal of Veterinary Science
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    • v.24 no.1
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    • pp.15.1-15.13
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    • 2023
  • Background: Inactivated vaccines are limited in preventing foot-and-mouth disease (FMD) due to safety problems. Recombinant virus-like particles (VLPs) are an excellent candidate for a novel vaccine for preventing FMD, given that VLPs have similar immunogenicity as natural viruses and are replication- and infection-incompetent. Objectives: The 3C protease and P1 polyprotein of type O FMD virus (FDMV) was expressed in yeast Hansenula polymorpha to generate self-resembling VLPs, and the potential of recombinant VLPs as an FMD vaccine was evaluated. Methods: BALB/c mice were immunized with recombinant purified VLPs using CpG oligodeoxynucleotide and aluminum hydroxide gel as an adjuvant. Cytokines and lymphocytes from serum and spleen were analyzed by enzyme-linked immunosorbent assay, enzyme-linked immunospot assay, and flow cytometry. Results: The VLPs of FMD were purified successfully from yeast protein with a diameter of approximately 25 nm. The immunization of mice showed that animals produced high levels of FMDV antibodies and a higher level of antibodies for a longer time. In addition, higher levels of interferon-γ and CD4+ T cells were observed in mice immunized with VLPs. Conclusions: The expression of VLPs of FMD in H. polymorpha provides a novel strategy for the generation of the FMDV vaccine.

Immunogenicity of 7-valent pneumococcal conjugate vaccine related to booster immunization in Korean children (한국 소아에서 7가 폐렴사슬알균 단백결합 백신의 추가접종 면역원성에 관한 연구)

  • Park, So Eun;Lee, Hyunju;Lim, Soo Young;Kim, Kyung Hyo
    • Clinical and Experimental Pediatrics
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    • v.51 no.6
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    • pp.622-628
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    • 2008
  • Purpose : The purpose of this study was to evaluate the immunogenicity of the booster immunization with pneumococcal conjugate vaccine in Korean children. Methods : Thirty-nine children aged 12-23 months who visited Kangnam CHA Hospital between September 2006 and December 2006 were enrolled. The children were divided into primary and booster groups depending on their vaccination status for the 7-valent pneumococcal conjugate vaccine. The anti-pneumococcal antibody levels of each serotype included in the vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) were determined by third-generation ELISA. Results : The geometric mean titer (GMT) of antibodies to each pneumococcal serotype in the booster group was higher than in the primary group (P<.05). The percentage of subjects with pneumococcal antibodies ${\geq}0.35{\mu}g/mL$ was 90.5-100% for all serotypes in both the primary and booster groups. The percentage of subjects with pneumococcal antibodies ${\geq}1.0g/mL$ in the booster group was 94.4-100%, which was higher than the primary group except for serotypes 6B and 14 (P<.05). The percentage of subjects with pneumococcal antibodies ${\geq}5.0{\mu}g/mL$ in the booster group was 50.0-94.4% which was higher than the primary group for all serotypes (P<0.05). Conclusion : The immunogenicity of a booster dose of the pneumococcal conjugate vaccine in Korean children was high and the immunogenicity of a primary series was also relatively high. To determine the feasibility of the introduction of the pneumococcal conjugate vaccine and the appropriate schedule for Korean children, further prospective investigation of the immunogenicity of the booster immunization is needed.

Adenovirus Vectors: Excellent Tools for Vaccine Development

  • Jun Chang
    • IMMUNE NETWORK
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    • v.21 no.1
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    • pp.6.1-6.11
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    • 2021
  • Adenovirus was originally used as a vector for gene therapy. In recent years, with the development of the next-generation vectors with increased safety and high immunogenicity to transgene products, its utility as a vaccine vector has continued to increase. Adenovirus-based vaccines are currently being tested not only to prevent various infectious diseases but also to be applied as cancer vaccines. In this review, I discuss the innate and adaptive aspects of the immunological characteristics of adenovirus vectors and further examine the current status of advanced adenovirus-based vaccine development. Various methods that can overcome the limitations of currently used adenoviruses as vaccine vehicles are also discussed. Through this study, I hope that vaccine development using adenovirus vectors will be expedited and more successful.

Immunogenicity and Safety of Recombinant Hepatitis B Vaccine(HG-IIR) in Healthy Infants and Children (유전자 재조합 B형간염 백신의 10세이하 소아에서의 면역원성 및 안전성)

  • Kim, Myoung Ah;Choi, Eun Ha;Jang, Mee Suk;Dong, Eun Sil;Jang, Seong Hee;Ahn, Young Min;Youn, Hee Sang;Sohn, Young Mo
    • Pediatric Infection and Vaccine
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    • v.4 no.1
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    • pp.106-115
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    • 1997
  • Objective : To evaluate the immunogenicity and safety afforded by the HG-II$^{(R)}$ recombinant hepatitis B vaccine given to healthy neonates and children and to find the influence of preceding BCG vaccination on immunogenicity. Methods : Three doses of recombinant hepatitis B vaccine with a dose of $10{\mu}g$ were given at birth, 1 and 6 months of age. This study was conducted in three hospitals (Gyeongsang National University Hospital(Group A), Kangnam General Hospital(Group B) and Younsei University Hospital(Group C)) from April, 1995 to June, 1996. Group A and Group B received 2nd dose of hepatitis B vaccine at 1 week after and before BCG vaccine, respectively. Antibidy levels, at 1 month after the 3rd dose of hepatitis B vaccine were determined by a radioimmunoassay. Results : 1) One hundred four infants and ten children were enrolled : 55 infants and 43 infants received 2nd dose of hepatitis B vaccine at 1 week after( After BCG Group) and before BCG vaccine(Before BCG Group), respectively. 2) The seropositive rate was 99.1%, and geometric mean anti-HBs titer was 131.2mIU/ml. 3) The geometric mean titers were 105.5mIU/ml and 162.8mIU/ml in After BCG and Before BCG Group, respectively(p<0.025). 4) Among 359 episodes of vaccination, the occurrence of systemic and local side reaction were reported in 7.8% and 1.4%, respectively. Conclusion : Recombinant hepatitis B vaccine(HG-II$^{(R)}$))was highly immunogenic and safe. The significantly lower geometric mean antibody titer in the BCG preceding group was observed. Well-designed controlled study with the large number of sample size will be required to show the influence of preceding BCG vaccination.

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Evaluation on Immunogenicity and Safety of Avian Influenza Isolate(ADL0401) as a Candidate for the Killed Vaccine against tow-Pathogenic Avian Influenza (약병원성 조류인플루엔자 사독백신개발을 위한 후보주(ADL0401)의 면역 원성 및 안전성 평가)

  • Lee J. S.;Ha D. H.;Kim J. E.;Ha B. D.;Mo I. P.
    • Korean Journal of Poultry Science
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    • v.32 no.2
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    • pp.113-123
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    • 2005
  • Avian influenza (AI) virus (AIV) is distributed worldwide and it has been isolated from various species of wild and domestic birds. AI transfers with high speed and shows diverse pathogenicity syndroms. In Korea, several low Pathogenic AIV, H9N2, have been isolated from the commercial farms with severe decrease of egg production and mortality resulted in severe economic loss since 1996. Therefore, it has been requested to develop AI vaccines to prevent clinical signs and economic losses from the field infection of AIV. To develop a killed vaccine that efficiently prevents low pathogenic AIV (H9N2), evaluation on the pathogenicity and selection of an inactivator for H9N2 is taking place and is being tested safety and immunogenicity of vaccine produced. Based on the pathogenicity test and viral reisolation test, the ADL0401 isolate is the characteristic low pathogenic AIVs and has fairly similar biologic functions compared with MS96 which is the official low pathogenic AIV (H9N2) and one of the predominant AIV isolated from poultry farms in Korea. In antigenicity tests, the ADL0401 and MS96 virus have no significant antigenic difference. In inactivation tests, the ADL0401 isolates can be easily inactivated with $0.1\%$ Formalin at $37^{\circ}C$ within 1 hour with a little decrease of HA titer. The vaccine developed in the present report has no harmful effect on bird and forms good immune capability. Therefore, the isolates, ADL0401 can be used for a killed vaccine which can reduce the clinical signs and viral shedding in the birds infected with H9N2 low pathogenic AIVs.

Immunogenicity of Exosomes from Dendritic Cells Stimulated with Toxoplasma gondii Lysates in Ocularly Immunized Mice

  • Jung, Bong-Kwang;Kim, Eun-Do;Song, Hyemi;Chai, Jong-Yil;Seo, Kyoung Yul
    • Parasites, Hosts and Diseases
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    • v.58 no.2
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    • pp.185-189
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    • 2020
  • Immunogenicity of dendritic cell-derived exosomes stimulated with Toxoplasma gondii lysates (TLA exo), mixed with cholera toxin as an adjuvant, was investigated in mice immunized via 2 mucosal routes (ocular vs intranasal). BALB/c mice were injected 3 times with TLA exo vaccine at 2 week interval, and the levels of IgG in serum and IgA in tear, saliva, feces, and vaginal wash were measured. To observe the expression of T. gondii-specific B1 gene, mice infected with ME49 T. gondii cysts were immunized with TLA exo or PBS exo (not stimulated with TLA), and their brain tissues were examined. The mice vaccinated via intranasal route elicited significantly higher humoral and mucosal immune responses compared with mice treated with PBS alone. Also, mice immunized via ocular route (by eyedrop) induced significantly higher T. gondii-specific IgG in serum and IgA in tear and feces in comparison with PBS controls. B1 gene expression was significantly lower in TLA exo vaccinated mice than in PBS or PBS exo vaccinated mice. These results demonstrated that ocular immunization of mice with TLA exo vaccine has the potential to stimulate systemic or local antibody responses. This study also highlighted an advantage of an eyedrop vaccine as an alternative for T. gondii intranasal vaccines.

Immunogenicity and Reactogenicity of Inactivated HM175 Strain Hepatitis A Vaccine in Healthy Korean Children (건강한 한국 소아에서 HM175주 A형 간염 불활화 백신의 면역원성 및 이상반응에 관한 연구)

  • Kim, Chang Hwi;Pyun, Bok Yang;Hong, Young Jin;Kang, Jin Han
    • Pediatric Infection and Vaccine
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    • v.7 no.1
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    • pp.120-128
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    • 2000
  • Purpose : Active immunization against hepatitis A with an inactivated vaccine reveals excellent immunogenicity, tolerability and protective efficacy. Inactivated hepatitis A vaccines have been selectively used since 1996 in Korea to prevent hepatitis A. This study was performed to assess the immunogenicity and reactogenicity after two doses of HM175 strain hepatitis A vaccine in healthy Korean children. Methods : 128 healthy children(M/F; 65/63) aged 1 to 15 years, who were seronegative for hepaitatis A, participated in this study. A alum-adsorbed vaccine containing 720 EL.U of antigen form HM175 hepatitis A strain per 0.5 mL dose was injected intramuscularly on the deltoid area. The second dose was given 6 months later, Anti-HAV antibodies were measured by ELISA before and 1 month after each vaccination to assess the immunogenicity. Any local and general adverse events were reported by patients parents with the prepared questionnaire after each vaccination. Results : 120 volunteers(M/F; 60/60) completed the whole series of the study. Seroconversion occurred in all cases after primary and booster vaccination. The mean anti-HAV antibody titer after primary vaccination was 389.2mIU/mL, and 3,609mIU/mL after booster vaccination. And levels of anti-HAV antibodies after booster immunization were significantly higher in female children. The most common local adverse event was soreness on the injection site, but it was mild and resolves within 3 days. Fever was not reported after booster vaccination. Conclusion : Based on these data, we conclude that the inactivated HM175 strain hepatitis A vaccine is highly immunogenic and tolerable in healthy Korean children.

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