• 제목/요약/키워드: Vaccines

검색결과 765건 처리시간 0.03초

Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years

  • Yoo, Byung Wook;Kim, Chang Oh;Izu, Allen;Arora, Ashwani Kumar;Heijnen, Esther
    • Infection and chemotherapy
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    • 제50권4호
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    • pp.301-310
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    • 2018
  • Backgroud: Influenza vaccination is recommended for adults aged ${\geq}65$ years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as $FLUAD^{(R)}$ and $VANTAFLU^{(R)}$, in South Korean subjects aged ${\geq}65$ years. Materials and Methods: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). Results: Of the 770 subjects enrolled ($FLUAD^{(R)}$, n = 389; $VANTAFLU^{(R)}$, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). Conclusion: These results show that the MF59-adjuvanted influenza vaccine known as $FLUAD^{(R)}$ or $VANTAFLU^{(R)}$ had acceptable safety profiles in older adults (aged ${\geq}65$ years) in South Korea.

항암치료를 받는 소화기 암환자에서 코로나바이러스 감염증-19 백신접종 (COVID-19 Vaccination in Patients with Gastrointestinal Cancer Receiving Chemotherapy)

  • 이종현;김동욱
    • Journal of Digestive Cancer Research
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    • 제10권2호
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    • pp.107-111
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    • 2022
  • In 2019, coronavirus disease (COVID-19), which originated in Wuhan, has spread worldwide. In most people, COVID-19 symptoms are not severe. However, the mortality rate and severity were high in risk groups such as in older people and patients with underlying diseases. As patients with cancer are one of the risk groups, the vaccination for COVID-19 is emphasized in these patients. However, COVID-19 vaccines are not tested enough in special groups such as in patients with cancer because these vaccines are developed at an unprecedented speed. This causes confusion about whether patients undergoing chemotherapy should be vaccinated or not. In this study, international guidelines and studies were reviewed. Most of the studies recommended vaccination. No evidences of any negative effects for the efficacy or safety were recorded in patients undergoing cytotoxic, targeted, and immune agents. However, in critical conditions such as cytopenia, vaccination must be decided according to the patient's condition. COVID-19 vaccines were also recommended for patients on surgery or radiation therapy. If possible, vaccine is given before surgery to avoid confusion between surgical complications and side effects of the vaccine. The radiation recall phenomenon after vaccination has been reported in some cases of radiation therapy. Clinicians should consider these situations before vaccinating each patient. We hope that clearer guidelines will be established by accumulating verified data.

면역보조제의 작용 및 개발 (A Current Research Insight into Function and Development of Adjuvants)

  • 손은수;손은화;표석능
    • IMMUNE NETWORK
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    • 제4권3호
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    • pp.131-142
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    • 2004
  • In recent years, adjuvants have received much attention because of the development of purified subunit and synthetic vaccines which are poor immunogens and require adjuvants to evoke the immune response. Therefore, immunologic adjuvants have been developed and testing for most of this century. During the last years much progress has been made on development, isolation and chemical synthesis of alternative adjuvants such as derivatives of muramyl dipeptide, monophosphoryl lipid A, liposomes, QS-21, MF-59 and immunostimulating complexes (ISCOMS). Biodegradable polymer microspheres are being evaluated for targeting antigens on mucosal surfaces and for controlled release of vaccines with an aim to reduce the number of doses required for primary immunization. The most common adjuvants for human use today are aluminum hydroxide and aluminum phosphate. Calcium phosphate and oil emulsions have been also used in human vaccination. The biggest issue with the use of adjuvants for human vaccines is the toxicity and adverse side effects of most of the adjuvant formulations. Other problems with the development of adjuvants include restricted adjuvanticity of certain formulations to a few antigens, use of aluminum adjuvants as reference adjuvant preparations under suboptimal conditions, non-availability of reliable animal models, use of non-standard assays and biological differences between animal models and humans leading to the failure of promising formulations to show adjuvanticity in clinical trials. The availability of hundreds of different adjuvants has prompted a need for identifying rational standards for selection of adjuvant formulations based on safety and sound immunological principles for human vaccines. The aim of the present review is to put the recent findings into a broader perspective to facilitate the application of these adjuvants in general and experimental vaccinology.

Vaccine Storage Practices and the Effects of Education in Some Private Medical Institutions

  • Lee, Sae-Rom;Lim, Hyun-Sul;Kim, Oh-Yon;Nam, Jeong-Gyeong;Kim, Yeong-Sun;Woo, Hyung-Rae;Noh, Woo-Jin;Kim, Kye-Nam
    • Journal of Preventive Medicine and Public Health
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    • 제45권2호
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    • pp.78-89
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    • 2012
  • Objectives: Although vaccination rates have increased, problems still remain in the storage and handling of vaccines. This study focused on inspecting actual vaccine storage status and awareness, and comparing them before and after education was provided. Methods: In the primary inspection, a status survey checklist was completed by visual inspection. A questionnaire on the awareness of proper vaccine storage and handling was also administered to vaccine administrators in private medical institutions in 4 regions in Gyeongsangbuk-province. One-on-one education was then carried out, and our self-produced manual on safe vaccine storage and management methods was provided. In the secondary inspection, the investigators visited the same medical institutions and used the same questionnaire and checklist used during the primary inspection. The results before and after education were compared, by treating each appropriate answer as 1 point. Results: The average checklists score was 9.74 (out of 15 points), which increased significantly after education was provided (by 0.84, p<0.001). The participants demonstrated improved practices in recording storage temperatures(p=0.016), storing vaccines in the center of the refrigerator (p=0.004), storing vaccines with other medication and nonmedical items (p=0.031) after education. The average score calculated from the questionnaires was 10.48 (out of 14points), which increased after education (by 1.03, p<0.001). Conclusions: This study suggests that vaccine storage practices and awareness are inadequate, but can be partially improved by providing relevant education. Repetitive education and policy-making are required to store vaccines safely because one-off education and unenforced guidelines offer limited efficacy.

Generation of a Human Monoclonal Antibody to Cross-Reactive Material 197 (CRM197) and Development of a Sandwich ELISA for CRM197 Conjugate Vaccines

  • Kim, Dain;Yoon, Hyeseon;Kim, Sangkyu;Wi, Jimin;Chae, Heesu;Jo, Gyunghee;Yoon, Jun-Yeol;Kim, Heeyoun;Lee, Chankyu;Kim, Se-Ho;Hong, Hyo Jeong
    • Journal of Microbiology and Biotechnology
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    • 제28권12호
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    • pp.2113-2120
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    • 2018
  • Cross-reactive material 197 ($CRM_{197}$) is a non-toxic mutant of diphtheria toxin containing a single amino acid substitution of glycine 52 with glutamic acid. $CRM_{197}$ has been used as a carrier protein for poorly immunogenic polysaccharide antigens to improve immune responses. In this study, to develop a sandwich ELISA that can detect $CRM_{197}$ and $CRM_{197}$ conjugate vaccines, we generated a human anti-$CRM_{197}$ monoclonal antibody (mAb) 3F9 using a phage-displayed human synthetic Fab library and produced mouse anti-$CRM_{197}$ polyclonal antibody. The affinity ($K_D$) of 3F9 for $CRM_{197}$ was 3.55 nM, based on Bio-Layer interferometry, and it bound specifically to the B fragment of $CRM_{197}$. The sandwich ELISA was carried out using 3F9 as a capture antibody and the mouse polyclonal antibody as a detection antibody. The detection limit of the sandwich ELISA was <1 ng/ml $CRM_{197}$. In addition, the 3F9 antibody bound to the $CRM_{197}$-polysaccharide conjugates tested in a dose-dependent manner. This ELISA system will be useful for the quantification and characterization of $CRM_{197}$ and $CRM_{197}$ conjugate vaccines. To our knowledge, this study is the first to generate a human monoclonal antibody against $CRM_{197}$ and to develop a sandwich ELISA for $CRM_{197}$ conjugate vaccines.

Steroid injections in pain management: influence on coronavirus disease 2019 vaccines

  • Hong, Sung Man;Park, Yeon Wook;Choi, Eun Joo
    • The Korean Journal of Pain
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    • 제35권1호
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    • pp.14-21
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    • 2022
  • The coronavirus disease 2019 (COVID-19) pandemic, which has been rampant since the end of 2019, has evidently affected pain management in clinical practice. Fortunately, a COVID-19 vaccination program is currently in progress worldwide. There is an ongoing discussion that pain management using steroid injections can decrease COVID-19 vaccine efficacy, although currently there is no direct evidence to support this statement. As such, the feeling of pain in patients is doubled in addition to the co-existing ill-effects of social isolation associated with the pandemic. Thus, in the COVID-19 era, it has become necessary that physicians be able to provide high quality pain management without negatively impacting COVID-19 vaccine efficacy. Steroids can alter the entire process involved in the generation of adaptive immunity after vaccination. The period of hypophysis-pituitary-adrenal axis suppression is known to be 1 to 4 weeks after steroid injection, and although the exact timing for peak efficacy of COVID-19 vaccines is slightly different for each vaccine, the average is approximately 2 weeks. It is suggested to avoid steroid injections for a total of 4 weeks (1 week before and after the two vaccine doses) for the double-shot vaccines, and for 2 weeks in total (1 week before and after vaccination) for a single-shot vaccine. This review focuses on the basic concepts of the various COVID-19 vaccines, the effect of steroid injections on vaccine efficacy, and suggestions regarding an appropriate interval between the administration of steroid injections and the COVID-19 vaccine.

Efficacy of bivalent vaccines of porcine circovirus type 2 and Mycoplasma hyopneumoniae in specific pathogen-free pigs challenged with porcine circovirus type 2d

  • Lim, Jeonggyo;Jin, Myongha;Yoon, Injoong;Yoo, Han Sang
    • Journal of Veterinary Science
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    • 제23권3호
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    • pp.49.1-49.13
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    • 2022
  • Background: Porcine circovirus type 2 (PCV2) and Mycoplasma hyopneumoniae (MHP) are economically significant pathogens in the pig industry. The use of combined vaccines against PCV2 and MHP is one of the most effective ways of protecting pigs from both diseases, and it has become a part of general management. Objectives: This study evaluated the efficacy of two new bivalent vaccines of PCV2 and MHP (Myco-X and Myco-XD) in SPF pigs. Myco-X and Myco-XD are a combined vaccine of MHP with PCV2b and PCV2d, respectively. Methods: Sixteen pigs were divided into four groups: Myco-X-vaccinated challenged, Myco-XD-vaccinated challenged, unvaccinated challenged, and unvaccinated unchallenged. Two milliliters of Myco-X were administered intramuscularly, and 0.5 mL of Myco-XD was injected intradermally at 3 wk of age. The pigs were challenged with virulent PCV2d via the intramuscular and intranasal route 4 wk post-vaccination. Results: All vaccinated pigs showed effective reduction of the clinical signs, the PCV2d load in the blood and nasal swab samples, as well as lung and lymphoid tissue lesions in the challenge test. Compared to unvaccinated challenged animals, the vaccinated challenged animals showed significantly higher (p < 0.05) levels of anti-PCV2 IgG, PCV2d-specific interferon-γ (IFN-γ), and anti-MHP IgG. Conclusions: Based on clinical, microbiological, serological, and pathological assessments, this study confirmed that both combined vaccines could protect pigs against PCV2 infection caused by PCV2d. On the other hand, further research on the efficacy evaluation of these new vaccines against the MHP challenge and PCV2d/MHP co-challenge is needed.

Micronutrients and prevention of cervical pre-cancer in HPV vaccinated women: a cross-sectional study

  • Chandrika J Piyathilake;Suguna Badiga;Nongnut Thao;Pauline E Jolly
    • 대한지역사회영양학회지
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    • 제28권1호
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    • pp.61-73
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    • 2023
  • Objectives: Prophylactic vaccines against high-risk human papillomaviruses (HR-HPVs) hold promise to prevent the development of higher grade cervical intraepithelial neoplasia (CIN 2+) and cervical cancer (CC) that develop due to HR-HPV genotypes that are included in HPV vaccines, but women will continue to develop CIN 2+ and CC due to HR-HPV genotypes that are not included in the quadrivalent HPV vaccine (qHPV) and 9-valent HPV vaccine (9VHPV). Thus, the current vaccines are likely to decrease but not entirely prevent the development of CIN 2+ or CC. The purpose of the study was to determine the prevalence and determinants of CIN 2+ that develop due to HR-HPVs not included in vaccines. Methods: Study population consisted of 1476 women tested for 37 HPVs and known to be negative for qHPVs (6/11/16/18, group A, n = 811) or 9VHPVs (6/11/16/18/31/33/45/52/58, group B, n = 331), but positive for other HR-HPVs. Regression models were used to determine the association between plasma concentrations of micronutrients, socio-demographic, lifestyle factors and risk of CIN 2+ due to HR-HPVs that are not included in vaccines. Results: The prevalence of infections with HPV 31, 33, 35 and 58 that contributed to CIN 2+ differed by race. In group A, African American (AA) women and current smokers were more likely to have CIN 2 (OR = 1.76, P = 0.032 and 1.79, P = 0.016, respectively) while in both groups of A and B, those with higher vitamin B12 were less likely to have similar lesions (OR = 0.62, P = 0.036 and 0.45, P = 0.035, respectively). Conclusions: We identified vitamin B12 status and smoking as independent modifiable factors and ethnicity as a factor that needs attention to reduce the risk of developing CIN 2+ in the post vaccination era. Continuation of tailored screening programs combined with non-vaccine-based approaches are needed to manage the residual risk of developing HPV-related CIN 2+ and CC in vaccinated women.

Sentiment Analysis for COVID-19 Vaccine Popularity

  • Muhammad Saeed;Naeem Ahmed;Abid Mehmood;Muhammad Aftab;Rashid Amin;Shahid Kamal
    • KSII Transactions on Internet and Information Systems (TIIS)
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    • 제17권5호
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    • pp.1377-1393
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    • 2023
  • Social media is used for various purposes including entertainment, communication, information search, and voicing their thoughts and concerns about a service, product, or issue. The social media data can be used for information mining and getting insights from it. The World Health Organization has listed COVID-19 as a global epidemic since 2020. People from every aspect of life as well as the entire health system have been severely impacted by this pandemic. Even now, after almost three years of the pandemic declaration, the fear caused by the COVID-19 virus leading to higher depression, stress, and anxiety levels has not been fully overcome. This has also triggered numerous kinds of discussions covering various aspects of the pandemic on the social media platforms. Among these aspects is the part focused on vaccines developed by different countries, their features and the advantages and disadvantages associated with each vaccine. Social media users often share their thoughts about vaccinations and vaccines. This data can be used to determine the popularity levels of vaccines, which can provide the producers with some insight for future decision making about their product. In this article, we used Twitter data for the vaccine popularity detection. We gathered data by scraping tweets about various vaccines from different countries. After that, various machine learning and deep learning models, i.e., naive bayes, decision tree, support vector machines, k-nearest neighbor, and deep neural network are used for sentiment analysis to determine the popularity of each vaccine. The results of experiments show that the proposed deep neural network model outperforms the other models by achieving 97.87% accuracy.

Adjuvanticity of Processed Aloe vera gel for Influenza Vaccination in Mice

  • Eun-Jung Song;Erica Espano;Jeong-Hyun Nam;Jiyeon Kim;Kyu-Suk Shim;Eunju Shin;Young In Park;Chong-Kil Lee;Jeong-Ki Kim
    • IMMUNE NETWORK
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    • 제20권4호
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    • pp.31.1-31.14
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    • 2020
  • The effectiveness of current influenza vaccines is considered suboptimal, and 1 way to improve the vaccines is using adjuvants. However, the current pool of adjuvants used in influenza vaccination is limited due to safety concerns. Aloe vera, or aloe, has been shown to have immunomodulatory functions and to be safe for oral intake. In this study, we explored the potential of orally administered processed Aloe vera gel (PAG) as an adjuvant for influenza vaccines in C57BL/6 mice. We first evaluated its adjuvanticity with a split-type pandemic H1N1 (pH1N1) Ag by subjecting the mice to lethal homologous influenza challenge. Oral PAG administration with the pH1N1 Ag increased survival rates in mice to levels similar to those of alum and MF59, which are currently used as adjuvants in influenza vaccine formulations. Similarly, oral PAG administration improved the survival of mice immunized with a commercial trivalent influenza vaccine against lethal homologous and heterologous virus challenge. PAG also increased hemagglutination inhibition and virus neutralization Ab titers against homologous and heterologous influenza strains following immunization with the split-type pH1N1 Ag or the commercial trivalent vaccine. Therefore, this study demonstrates that PAG may potentially be used as an adjuvant for influenza vaccines.