• Title/Summary/Keyword: inactivated vaccine

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Post-marketing Surveillance Study of an Inactivated Split-Virion Influenza Vaccine in Korea (불활화 분할 인플루엔자 백신의 국내 시판 후 조사 연구)

  • Huh, Jae-Won;Ma, Sang-Hyuk;Kim, Hyun-Kyun;Gunapalaiah, Bhavyashree;Bock, Hans L.;on behalf of the Fluarix-054 Study Group,
    • Pediatric Infection and Vaccine
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    • v.18 no.1
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    • pp.68-79
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    • 2011
  • Purpose : This post-marketing surveillance study (NCT00750360) assessed the safety and reactogenicity of an inactivated, trivalent split-virion influenza vaccine licensed for use in the Korea since 2002. Methods : Eight hundred and eighty three subjects aged 6 months received a single dose of the ${\geq}$ vaccine; an additional dose was administered to those aged <9 years and unprimed with an influenza vaccine. Four hundred and eleven subjects used diary cards to record safety information; this report presents data from these subjects. Incidence of solicited local, general and unsolicited adverse events (4-days and 21-days post-vaccination follow-up periods, respectively) were recorded. Serious adverse events (SAEs) were recorded throughout the study period. Results : Injection site pain (subjects aged <6 years: 12.6% of subjects, ${\geq}$6 years: 34.7%), fever (<6 years: 1.3%) and myalgia (${\geq}$6 years: 13.9%) were the most frequently recorded solicited local and general adverse events. Grade 3 solicited adverse events were reported by ${\leq}$4.0% subjects. No vaccine-related SAEs were recorded (KFDA criteria). Conclusion : Considering the vaccine's well-established immunogenicity and its favourable safety and reactogenicity profile across all age groups and its high coverage rate in Korea, it may be recommended as a candidate to facilitate annual seasonal influenza vaccination for all ages as part of the Korean National Immunization Program.

Hematological Studies in Reference to Immune Enhancement Mechanism of Formalin Applied to Formalin Inactivated Anthrax Vaccines in Rabbits (Formalin 처리(處理) 면역원(免疫原)에 대한 가토(家兎)의 혈액세포상(血液細胞像)에 관한 연구)

  • Jeon, Yun Seong;Choi, Hi In
    • Korean Journal of Veterinary Research
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    • v.16 no.1
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    • pp.45-51
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    • 1976
  • Hematological studies were conducted in reference to the immune enhancing mechanism of formalin applied to, as an inactivating agent, a formalin inactivaed anthrax vaccines in rabbits. Rabbits were inoculated two types of formalinized anthrax immunogens namely capsular and spore vaccines in addition of formalin saline as a control. From immune rabbits, peripheral blood was collected and subjected to count a total erythrocytes, leukocytes, and pyroninophilic lymphocytes. The experimental results were summarized as followings. At a level of 0.5M 0.5ml formalin with or without the addition to vaccine, a total leukocytes count was increased. Due to the increased lymphocytes, the ratio of neutrophil and lymphocyte was lowered within 4 to 12 hours of the postinoculation. Formalin saline, anthrax spore vaccine and capsular vaccine, without group difference, caused an increased level of pyroninophilic lymphocytes in peripheral blood. Throughout the studies, a possible role of immune enhancement by formlin was disscused and suggested.

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Improved Purification Process for Cholera Toxin and its Application to the Quantification of Residual Toxin in Cholera Vaccines

  • Jang, Hyun;Kim, Hyo-Seung;Kim, Jeong-Ah;Seo, Jin-Ho;Carbis, Rodney
    • Journal of Microbiology and Biotechnology
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    • v.19 no.1
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    • pp.108-112
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    • 2009
  • A simplified method for the purification of cholera toxin was developed. The 569B strain of Vibrio cholerae, a recognized hyper-producer of cholera toxin, was propagated in a bioreactor under conditions that promote the production of the toxin. The toxin was separated from the bacterial cells using 0.2-${\mu}m$ crossflow microfiltration, the clarified toxin was passed through the membrane into the permeate, and the bacterial cells were retained in the retentate. The 0.2-${\mu}m$ permeate was then concentrated 3-fold and diafiltered against 10 mM phosphate buffer, pH 7.6, using 30-kDa crossflow ultrafiltration. The concentrated toxin was loaded onto a cation exchange column, the toxin was bound to the column, and most of the impurities were passed unimpeded through the column. The toxin was eluted with a salt gradient of phosphate buffer, pH 7.0, containing 1.0 M NaCl. The peak containing the toxin was assayed for cholera toxin and protein and the purity was determined to be 92%. The toxin peak had a low endotoxin level of $3.1\;EU/{\mu}g$ of toxin. The purified toxin was used to prepare antiserum against whole toxin, which was used in a $G_{M1}$ ganglioside-binding ELISA to determine residual levels of toxin in an oral inactivated whole-cell cholera vaccine. The $G_{M1}$ ganglioside-binding ELISA was shown to be very sensitive and capable of detecting as little as 1 ng/ml of cholera toxin.

Studies on the Antigenicity and Immunogenicity of Newcastle Disease Virus Inactivated with Binary Ethylenimine (Binary Ethylenimine으로 불활화(不活化)한 Newcastle Disease Virus의 항원성(抗原性)과 면역원성(免疫原性)에 관한 연구(硏究))

  • Park, Bong-kyun;Jeon, Yun-seong;Lee, Young-soon;Rhee, Young-ok
    • Korean Journal of Veterinary Research
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    • v.25 no.2
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    • pp.155-165
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    • 1985
  • Effects of binary ethylenimine (BEI) treatment on the inactivation of infectivity and hemagglutinin of Newcastle disease virus (NDV) were studied in comparison with those of formalin treatment. Immune responses of chickens vaccinated with BEI-inactivated NDV vaccines were also investigated. The results were summarized as followings; 1. Complete loss of infectivity of NDV (Bl) was observed at 3, 7, and 24 hours after the treatment at $37^{\circ}C$ with BEI concentrations of 0.01M, 0.005M and 0.001M, respectively. 2. The hemagglutinin activity of NDV (Bl) remained constant when treated with 0.01M BEI at $37^{\circ}C$. However, it gradually decreased when treated with 0.1% or 0.2% formalin at $37^{\circ}C$. 3. When 4-week-old chickens were vaccinated with NDV vaccines prepared from Bl or Miyadera strains of NDV, inactivated with 0.1M BEI and adsorbed to aluminium hydroxide gel, favorable immune responses were observed throughout the 8 weeks of observation period. 4. When these chickens were revaccinated at 8 weeks after the first vaccination, strong anamnestic responses were evoked and the immunity maintained for 4 weeks of the observation. Though slightly bettor immune responses were observed after primary vaccination in chickens vaccinated with Bl vaccine compared with those vaccinated with Miyadera vaccine, the differences were not significant. 5. On the electron microscopy, BEI (0.01M) gave least effect to the envelope as well as capsid of NDV.

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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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    • v.13 no.1
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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.

Natural Killer and CD8 T Cells Contribute to Protection by Formalin Inactivated Respiratory Syncytial Virus Vaccination under a CD4-Deficient Condition

  • Eun-Ju Ko;Youri Lee;Young-Tae Lee;Hye Suk Hwang;Yoonsuh Park;Ki-Hye Kim;Sang-Moo Kang
    • IMMUNE NETWORK
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    • v.20 no.6
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    • pp.51.1-51.17
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    • 2020
  • Respiratory syncytial virus (RSV) causes severe pulmonary disease in infants, young children, and the elderly. Formalin inactivated RSV (FI-RSV) vaccine trials failed due to vaccine enhanced respiratory disease, but the underlying immune mechanisms remain not fully understood. In this study, we have used wild type C57BL/6 and CD4 knockout (CD4KO) mouse models to better understand the roles of the CD4 T cells and cellular mechanisms responsible for enhanced respiratory disease after FI-RSV vaccination and RSV infection. Less eosinophil infiltration and lower pro-inflammatory cytokine production were observed in FI-RSV vaccinated CD4KO mice after RSV infection compared to FI-RSV vaccinated C57BL/6 mice. NK cells and cytokine-producing CD8 T cells were recruited at high levels in the airways of CD4KO mice, correlating with reduced respiratory disease. Depletion studies provided evidence that virus control was primarily mediated by NK cells whereas CD8 T cells contributed to IFN-γ production and less eosinophilic lung inflammation. This study demonstrated the differential roles of effector CD4 and CD8 T cells as well as NK cells, in networking with other inflammatory infiltrates in RSV disease in immune competent and CD4-deficient condition.

A Collaborative Study on Korean Standard JE Vaccine for Potency Assay

  • Kim, Jae-Ok;Shin, Jin-Ho;Baek, Sun-Young;Min, Kyung-Il;Min, Bok-Soon;Ryu, Seung-Rel;Kim, Byoung-Guk;Kim, Do-Keun;Ahn, Mi-Jin;Park, Mi-Kyung;Song, Hye-Won;Lee, Chung-Keel;Lee, Seok-Ho;Park, Sue-Nie
    • Journal of Microbiology and Biotechnology
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    • v.14 no.4
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    • pp.745-750
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    • 2004
  • The objective of this collaborative study was to establish a Korean standard of Japanese encephalitis (JE) vaccine (mouse brain-derived, formalin-inactivated) for potency assay. A candidate preparation proposed as a Korean standard was provided by GreenCross Vaccine, and six laboratories, including one national control laboratory and five manufacturers of JE vaccine, participated in the study. The potency of the candidate preparation and a reference standard obtained from Japan was estimated by mouse immunogenicity assay using the in vitro plaque reduction neutralization test (PRNT). The results of 72 assays conducted by the 6 laboratories showed that the overall mean potency estimate of the candidate preparation was 2.455 log median plaque reduction neutralization antibody titer per 0.5-ml dosage administered twice in mice at 7-day intervals, and that the mean potency ratio of the candidate preparation relative to the reference standard was 1.074. The potency estimates were quite variable among laboratories irrespective of the preparation. The variability of assays assessed by Z scores and coefficient of variation (CV) were in general within the level of acceptance (Z scores within $\pm3$ and $CV\;\leq\;15%$). Therefore, we concluded that the candidate preparation would be suitable as a national standard for testing the potency of JE vaccine (inactivated).

Immunological relationships of FMD vaccine strain and Asia1 field isolate from East Asia (동아시아 유래 구제역바이러스 Asia1혈청형과 백신항원의 면역학적 상관성)

  • Park, Jong-Hyeon;Ko, Young-Joon;Kim, Su-Mi;Lee, Hyang-Sim;Lee, Kwang-Nyeong;Cho, In-Soo
    • Korean Journal of Veterinary Research
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    • v.49 no.3
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    • pp.221-229
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    • 2009
  • Foot-and-mouth disease (FMD) is the most contagious disease of mammals. The use of inactivated vaccine can be chosen to prevent or control FMD. However, vaccination against one serotype of FMDV doses not cross-protect against other serotypes and may not protect fully against some strains of the same serotype. Appropriate selection of vaccine strain is an important element in the control of FMD. The immunity of vaccine antigens should be matched against newly circulating viruses. The phylogenetic analysis of serotype Asia1 reported from China, Mongolia, North Korea and Russia since 2005 shows that they are all classified into genetic group V, but the strain, Asia1/Shamir (ISR/89) which have been used as a vaccine strain in Korea, is clustered into different genetic group. So, in this study the serological relationship between the isolate (Asia1/MOG/05; MOG) and the Shamir strain was determined by ELISA and virus neutralization test. Even though the matching value of the virus (MOG) against the vaccinated sera in target animals was not so high, the vaccinated animals elicited antibodies enough for protection after vaccinated once or twice. Conclusively, we suggest that the vaccine containing Asia1/Shamir antigen could protect the genetic group V strains circulating in East Asia currently if vaccinated twice or the more.