• 한국임상약학회지
• /
• 제29권3호
• /
• pp.173-185
• /
• 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.

• 대한수의학회지
• /
• 제49권2호
• /
• pp.127-133
• /
• 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.

• 한국임상약학회지
• /
• 제20권1호
• /
• pp.56-65
• /
• 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
• /
• 제23권2호
• /
• pp.117-127
• /
• 2016

목적: 2000년부터 식품의약품안전처 주관 하에 국내 주요 백신의 안전성과 면역원성에 대한 임상평가 자료를 확보하기 위한 백신 평가 연구를 시작하였다. 본 연구는 백신의 면역원성, 효능, 효과, 안전성 및 다른 평가분야에 대해 수행된 연구 및 보고서들을 고찰하여 각 백신 별 유용성 평가 자료를 찾아 분석하고자 하였다. 방법: 지난 2000년부터 2014년까지 여러 연구자들에 의해 "백신 유용성 평가" 과제가 수행되었다. 백신 유용성 평가 자료들의 결과 및 성과들을 고찰하여 향후 국내 백신 정책에 활용할 수 있는 가능성을 분석하였다. 각 백신은 백신 평가 영역에 따라 자료를 분석하고 체계화하였다. 결과: 2000년부터 2014년까지 주요 백신에 대해 총 83개의 연구과제가 수행되었다. 각 백신 별로는 BCG 8개, DTaP/Td 14개, 폴리오 1개, Hib 5개, 폐구균 3개, 인플루엔자 11개, A형 간염 3개, MMR 11개, 수두 11개, 일본뇌염 16개였다. 평가 영역은 안전성, 면역원성, 면역도, 면역지속능, 효능평가, 효과평가, 유효성 평가기술, 품질평가 및 기타로 나누어 분석하였다. 결론: 우리나라에서 수행된 백신 유용성 평가 연구를 통해 유용한 자료가 도출되어 향후 국내 백신 평가 사업, 백신 정책 수립 및 대중/전문가 교육에 필요한 기초자료로 활용될 수 있을 것이다.

• 약학회지
• /
• 제50권1호
• /
• pp.33-39
• /
• 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
• /
• 제32권4호
• /
• pp.269-274
• /
• 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.

• 인터넷정보학회논문지
• /
• 제19권2호
• /
• pp.77-88
• /
• 2018

자궁경부암 예방을 위해 2016년 6월부터 만 12세 여아에 대한 자궁경부암 예방백신 무료접종이 실시되고 있다. 이 연구는 언론이 자궁경부암 예방백신 부작용이라는 리스크 정보에 대해 어떻게 보도하였는지 살펴보고, 정부의 위험 커뮤니케이션 및 정책홍보에의 함의를 제시하고자 하였다. 구체적으로 자궁경부암 예방백신 무료접종이 시작되기 전 6개월을 1기(정책결정 단계)로, 무료접종이 실시된 후 6개월을 2기(정책집행 단계)로 시기를 구분하여 자궁경부암 백신 부작용 및 안전성 관련 기사 314건을 분석하였다. 내용분석 및 네트워크 분석 결과, 1기보다 2기에 관련한 기사의 수가 증가하였으며, 질병관리본부에서 자궁경부암 백신의 안전성을 강조하고, 백신의 효과를 부각시키면서 접종을 권유한 내용이 언론보도의 한 축을 이루었다. 자궁경부암 백신의 부작용과 관련하여 1기에는 일본의 백신 접종 피해사례를 중심으로 보도되었고 이에 대한 학부모의 우려가 보도되었으나, 2기에는 일본 뿐만 아니라 유럽, 미국 등 세계 각국의 피해 사례가 빈번히 보도되었다. 향후 자궁경부암 예방백신 접종률을 높이기 위해서는 자궁경부암 백신 관련한 막연한 두려움이나 불안감이 증폭되지 않도록 전략적인 접근을 해야 할 시점이다.

• IMMUNE NETWORK
• /
• 제5권2호
• /
• pp.89-98
• /
• 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
• /
• 제15권2호
• /
• pp.108-114
• /
• 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.

• 대한수의학회지
• /
• 제55권4호
• /
• pp.227-232
• /
• 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.