• Korean Journal of Clinical Pharmacy
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• v.29 no.3
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• pp.173-185
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• 2019

Objective: To gather inputs from clinical experts on selecting and prioritizing research topics, to address unmet vaccine safety needs. Methods: A questionnaire containing 15 vaccine safety assessment research proposals was sent to 28 vaccine experts chosen from various domestic medical association boards, and the rationale for each of the proposals was provided by presenting the following information: 1) a brief summary of the clinical safety studies on the vaccine, conducted by the Clinical Immunization Safety Assessment (CISA) project group, supervised by the United States Center for Disease Control (U.S. CDC), and 2) a summary of recently published studies that address vaccine safety issues. The experts were instructed to select and rank 5 topics in the order of preference, and the preference score for each proposed topic was calculated by assigning points on a scale of 1 to 5. Results: All 28 experts responded to the questionnaire, and the following topics were selected according to their calculated preference scores: 1) Human papillomavirus vaccine safety profile in the Korean female adolescents; 2) A signal detection of adverse events following Influenza vaccination: comparison between the US and South Korea; 3) Incidence of anaphylaxis following National Immunization Program vaccines between 2008 and 2017; 4) Safety of quadrivalent influenza vaccines compared to trivalent influenza vaccines; and 5) Pneumococcal vaccine safety profile in the general population. Conclusion: Five research topics addressing vaccine safety were selected, for which well-constructed research protocols need to be promptly developed to address current unmet vaccine safety needs in South Korea.

• Korean Journal of Veterinary Research
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• v.49 no.2
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• pp.127-133
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• 2009

Salmonella enterica subsp. enterica serovar gallinarum (S. gallinarum) is the agent of fowl typhoid, and the 9R vaccine is a commercial live vaccine for the prevention of fowl typhoid. The aim of this study was to assess the safety and immunogenicity of different brands of S. gallinarum 9R vaccine used in commercial laying chickens in Korea. All 9R strains originated from three different brands showed the same pattern in the biochemical and serological properties, and pulsed field gel electrophoresis (PFGE) profile. But, there was a difference in rhamnose fermentaion, agglutination with Salmonella group $D_1$ antiserum and PFGE pattern between 9R vaccine strain and field S. gallinarum isolates. In laboratory and field trials for assesment of safety and immunogenicity of 9R vaccine, all of the three 9R vaccines showed the same safety in commercial laying chickens. In addition, there was a significant difference between the vaccinated and unvaccinated control groups in mortality and the re-isolation rate of the challenge strain from the tissues (p < 0.05), and no difference by the brands of 9R vaccine. The results from this study indicated that all three different brands of S. gallinarum 9R vaccine showed highly protection against mortality and organ invasion in commercial laying chickens exposed to virulent strains of S. gallinarum.

• Korean Journal of Clinical Pharmacy
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• v.20 no.1
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• pp.56-65
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• 2010

Objective: This study aimed to develop information materials on vaccine's safety and adverse events which can be utilized by healthcare professionals when prescribing, dispensing and administering vaccines and also by non-healthcare professionals such as pharmaceutical distributors of vaccine. Methods: Information materials regarding vaccines from domestic and foreign governmental organizations, academies, medical organizations and pharmaceutical companies were reviewed. Advisory Committee which consisted of experts in the areas of the vaccine's safety verified the contents and the final information material. Results: Based on the collected data, we developed general guidelines including vaccine constituents, safety information and adverse events of each vaccines, storage and handling, and labeling information. The information materials were developed for both healthcare professionals and non-healthcare professionals such as vaccine distributors. Conclusion: Information materials on vaccine's safety and adverse events developed from this study could be utilized to provide useful information on the vaccine to the medical institutions and distributors.

• Pediatric Infection and Vaccine
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• v.23 no.2
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• pp.117-127
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• 2016

Purpose: Vaccine evaluation studies were initiated from 2000 by the Ministry of Food and Drug Safety to produce proper data about the safety and immunogenicity of vaccines. The purpose of this study was to review studies and reports on evaluation of vaccine such as immunogenicity, efficacy, effectiveness, safety and other related topics in order to find and analyze the data on the usefulness of each vaccine. Methods: From 2000 to 2014, the project "The vaccine evaluation" had been performed by several researchers, and studies and reports of vaccine evaluation. We reviewed the results and outcomes of studies regarding the evaluation of vaccine's usefulness and analyzed the possibilities of applying these data for establishing vaccine policies. For each vaccine, data analysis and organization were done according to evaluation fields. Results: A total of 83 studies were performed on vaccines from 2000 to 2014. For each vaccine, 8 studies were performed on BCG, 14 on DTaP/Td, 1 on poliovirus, 5 on Hib, 3 on pneumococcus, 11 on influenza, 3 on hepatitis A, 11 on MMR, 11 on varicella, and 16 on Japanese encephalitis. All studies were analyzed by the following evaluation area, such as safety, immunogenicity, seroprevalence, persistence of immunity, efficacy, effectiveness, vaccine evaluation methods, quality control product for vaccine, and others. Conclusions: Vaccine evaluation studies performed in Korea may be useful as references for establishing vaccination strategy and policy and could be used as baseline data for future studies on vaccine evaluation, vaccine policy establishment, and public/expert vaccine education in Korea.

• YAKHAK HOEJI
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• v.50 no.1
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• pp.33-39
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• 2006

We have previously reported the minimum criteria that can be applied to evaluate efficacy and safety of a DNA vaccine with use of Streptococcus pneumoniae DNA vaccine (SPDNA). The SPDNA was formulated by inserting the DNA sequences that are codons specific for the carbohydrate epitope in the capsule of S. penumoniae by phage display peptide library. Administration of the SPDNA into mice induced both humoral and cell-mediated immunities. The induction was protective even in the absence of CD4+ T lymphocyte in mice. Profiles of cytokine and isotyping of antibody displayed tendency of the Th1. In continuation of these studies, we examined if the efficacy of the SPNDA was provoked by the peptide recognized by codons specific for the capsule. Results showed that the peptide vaccine formulae (SPP) induced protective antibody in mice as did the SPDNA. Involvement of the cell-mediated immunity was also determined. Possible side effects of autoimmune diseases such as myositis and C3a production and tumor-formation were undetectable in mice given 7 times of SPDNA vaccination during entire of 92 days. Even after the frequent immunization, immunogenicity of the SPDNA was observed as determined for antibody production, suggesting that there was no immunotolerance provoked. All together, these examining factors would be applied to measurement of a DNA vaccine safety regarding the immunopathological aspect.

• Toxicological Research
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• v.32 no.4
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• pp.269-274
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• 2016

The potency of influenza vaccine is determined based on its hemagglutinin (HA) content. In general, single radial immunodiffusion (SRID) assay has been utilized as the standard method to measure HA content. However, preparation of reagents for SRID such as antigen and antibody takes approximately 2~3 months, which causes delays in the development of influenza vaccine. Therefore, quantification of HA content by other alternative methods is required. In this study, we measured HA contents of H1N1 antigen and H1N1 influenza vaccine by reverse phase-high performance liquid chromatography (RP-HPLC) methods. The presence of HA1 and HA2 was investigated by silver staining and Western blot assay. In addition, accuracy and repeatability of HA measurement by RP-HPLC were evaluated. Comparison of HA concentration by SRID and RP-HPLC revealed a precise correlation between the two methods. Our results suggest that RP-HPLC assay can replace SRID in the event of a pandemic flu outbreak for rapid vaccine development.

• Journal of Internet Computing and Services
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• v.19 no.2
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• pp.77-88
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• 2018

In order to prevent cervical cancer, free vaccination against cervical cancer(HPV vaccine) for 12-year-old girls has been ongoing since June 2016. The purpose of this study is to investigate how the media reported the risk information of HPV vaccine side effects and to suggest implications for government's risk communication and policy PR. The time frame was divided into two stages, stage 1(policy formation stage, 6 months before the start of free HPV vaccination) and stage 2(policy execution stage, 6 months after the free HPV vaccination was implemented). A total of 314 news articles on HPV vaccine safety and HPV Vaccine side effects were analyzed by content analysis and network analysis. The number of articles increased at stage 2 and the Centers for Disease Control and Prevention emphasized the safety of HPV vaccine and encouraged the inoculation while highlighting the effectiveness of the vaccine. Regarding HPV vaccine side effects, cases against vaccination in Japan were mainly reported at stage 1, whereas cases of HPV vaccine side effects from other countries such as Europe and USA were frequently reported at stage 2. In order to increase vaccination rate of HPV vaccine, it is time to take a strategic approach to prevent vague fear or anxiety about the vaccine.

• IMMUNE NETWORK
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• v.5 no.2
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• pp.89-98
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• 2005

Background: DNA vaccination represents an anticipated approach for the control of numerous infectious diseases. Used alone, however, DNA vaccine is weak immunogen inferior to viral vectors. In recent, heterologous prime-boost vaccination leads DNA vaccines to practical reality. Methods: We assessed prime-boost immunization strategies with a DNA vaccine (minigene, $gB_{498-505}$ DNA) and recombinant vaccinia virus $(vvgB_{498-505})$ expressing epitope $gB_{498-505}$ (SSIEF ARL) of CD8+ T cells specific for glycoprotein B (gB) of herpes simplex virus (HSV). Animals were immunized primarily with $gB_{498-505}$ epitope-expressing DNA vaccine/recombinant vaccinia virus and boosted with alternative vaccine type expressing entire Ag. Results: In prime-boost protocols using vvgBw (recombinant vaccinia virus expressing entire Ag) and $vvgB_{498-505}$, CD8+ T cell-mediated immunity was induced maximally at both acute and memory stages if primed with vvgBw and boosted with $vvgB_{498-505}$ as evaluated by CTL activity, intracellular IFN-staining, and MHC class I tetramer staining. Similarly $gB_{498-505}$ DNA prime-gBw DNA (DNA vaccine expressing entire Ag) boost immunization elicited the strongest CD8+ T cell responses in protocols based on DNA vaccine. However, the level of CD8+ T cell-mediated immunity induced with prime-boost vaccination using DNA vaccine expressing epitope or entire Ag was inferior to those based on vvgBw and $vvgB_{498-505}$. Of particular interest CD8+ T cell-mediated immunity was optimally induced when $vvgB_{498-505}$ was used to prime and gB DNA was used as alternative boost. Especially CD7+ T cell responses induced by such protocol was longer lasted than other protocols. Conclusion: These facts direct to search for the effective strategy to induce optimal CD8+ T cell-mediated immunity against cancer and viral infection.

• Pediatric Infection and Vaccine
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• v.15 no.2
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• pp.108-114
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• 2008

Japanese encephalitis is the leading cause of viral encephalitis in Asia, where it accounts for up to 50,000 cases. Approximately 20% of affected patients die, and 30-50% of survivors have significant neurological sequelae. Inactivated mouse-brain derived Japanese encephalitis vaccines has been effectively implemented to control the disease effectively in Korea and several other Asian countries. However, the vaccine is expensive and difficult to produce, requires multiple doses, and has been associated with hypersensitivity reactions and rare adverse neurologicale events. The live-attenuated SA14-14-2 vaccine derived from primary hamster kidney (PHK) cells was developed in China and has been used there since 1988. Outside China, it has been licensed and used in Korea and several other Asian countries. This vaccine is effective and inexpensive. However, the lack of precedence for using a PHK cell substrate in a live-attenuated vaccine is a special issue of concern. The WHO working group has recommended additional safety studies in selected high-risk groups, as well as ongoing post-marketing studies to ensure long-term safety. Recently, a new inactivated vaccine and live-attenuated chimeric vaccine have been developed from vero cells. With this background, this article summarized the current status of Japanese encephalitis vaccination worldwide and in Korea.

• Korean Journal of Veterinary Research
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• v.55 no.4
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• pp.227-232
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• 2015

Akabane and bovine ephemeral fever (BEF) viruses cause vector-borne diseases. In this study, inactivated Akabane virus (AKAV)+Bovine ephemeral fever virus (BEFV) vaccines with or without recombinant vibrio flagellin (revibFlaB) protein were expressed in a baculovirus expression system to measure their safety and immunogenicity. Blood was collected from mice, guinea pigs, sows, and cattle that had been inoculated with the vaccine twice. Inactivated AKAV+BEFV vaccine induced high virus neutralizing antibody (VNA) titer against AKAV and BEFV in mice and guinea pigs. VNA titers against AKAV were higher in mice and guinea pigs immunized with the inactivated AKAV+BEFV vaccine than in animals inoculated with vaccine containing revibFlaB protein. Inactivated AKAV+BEFV vaccine elicited slightly higher VNA titers against AKAV and BEFV than the live AKAV and live BEFV vaccines in mice and guinea pigs. In addition, the inactivated AKAV+BEFV vaccine was safe, and induced high VNA titers, ranging from 1 : 64 to 1 : 512, against both AKAV and BEFV in sows and cattle. Moreover, there were no side effects observed in any treated animals. These results indicate that the inactivated AKAV+BEFV vaccine could be used in cattle with high immunogenicity and good safety.