Therapeutic Advances in Vaccines and Immunotherapy最新文献

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Evaluation of two commercially-available Salmonella vaccines on Salmonella in the peripheral lymph nodes of experimentally-infected cattle. 两种市售沙门氏菌疫苗对实验感染牛外周淋巴结沙门氏菌的影响。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-10-05 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520957760
Thomas S Edrington, Terrance M Arthur, Guy H Loneragan, Kenneth J Genovese, Devin L Hanson, Robin C Anderson, David J Nisbet
{"title":"Evaluation of two commercially-available <i>Salmonella</i> vaccines on <i>Salmonella</i> in the peripheral lymph nodes of experimentally-infected cattle.","authors":"Thomas S Edrington,&nbsp;Terrance M Arthur,&nbsp;Guy H Loneragan,&nbsp;Kenneth J Genovese,&nbsp;Devin L Hanson,&nbsp;Robin C Anderson,&nbsp;David J Nisbet","doi":"10.1177/2515135520957760","DOIUrl":"https://doi.org/10.1177/2515135520957760","url":null,"abstract":"<p><strong>Background: </strong><i>Salmonella</i> is a common inhabitant of the ruminant gastrointestinal tract, where it often resides asymptomatically and may be shed into the feces. More recently it was discovered that <i>Salmonella</i> may be contained within the peripheral, non-mesenteric lymph nodes, where it is impervious to in-plant pathogen control interventions and may serve as a source of <i>Salmonella</i>-contamination of ground beef. Over the past 10 years considerable research effort has been expended at understanding how this pathogen gets to these lymph nodes, the duration of infection, and, most importantly, screening and developing potential intervention strategies that may be employed on farm prior to the animal being presented for slaughter.</p><p><strong>Methods: </strong>Utilizing an experimental model of <i>Salmonella</i> inoculation of bovine peripheral lymph nodes (PLNs), two pilot vaccine experiments were conducted to evaluate two <i>Salmonella</i> vaccines: <i>Salmonella</i> Newport Bacterial Extract (Experiment I) and Endovac-Bovi<sup>®</sup> (Experiment II) on preventing <i>Salmonella</i> acquisition by these nodes. In Experiment I, 4 months following the booster vaccination, 30 steers were inoculated with three <i>Salmonella</i> serotypes intradermally: Newport, Montevideo, and Anatum administered to the right legs, left legs, and to the caudal thorax and abdomen, respectively. Cattle were inoculated every other day over the course of five days (three total inoculation events) and 6 and 12 days following the final <i>Salmonella</i> inoculation, 16 and 14 head in each treatment were euthanized, respectively. In Experiment II, 12 head of Holstein steers were utilized. Seven days following the booster and weekly thereafter for 3 weeks (four total inoculation events), cattle were inoculated as above and euthanized 7 days following final inoculation. Right and left sub-iliac, popliteal and pre-scapular lymph nodes were collected in each experiment, weighed and cultured for <i>Salmonella</i>.</p><p><strong>Results: </strong>In Experiment I, no treatment differences were observed in <i>Salmonella</i> prevalence 6 days post-inoculation (necropsy 1). However, in vaccinated cattle at the second necropsy, a reduction (<i>p</i> = 0.05) in <i>Salmonella</i> prevalence was observed in the sub-iliac and pre-scapular lymph nodes as well as when all nodes were evaluated collectively (<i>p</i> = 0.04). In Experiment II, the vaccine reduced (<i>p</i> = 0.03) <i>Salmonella</i> prevalence in the right popliteal and tended (<i>p</i> = 0.09) to decrease prevalence in both popliteal lymph nodes.</p><p><strong>Conclusion: </strong>Under these experimental conditions, the data generated provide evidence of a partial vaccine effect on <i>Salmonella</i> within PLNs and indicate that further research may be warranted.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520957760"},"PeriodicalIF":0.0,"publicationDate":"2020-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2515135520957760","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38522027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 8
Delivery of adoptive cell therapy in the context of the health-care system in the UK: challenges for clinical sites. 在英国卫生保健系统的背景下,过继细胞疗法的交付:临床站点的挑战。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-09-20 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520944355
Manon Pillai, Michelle M Davies, Fiona C Thistlethwaite
{"title":"Delivery of adoptive cell therapy in the context of the health-care system in the UK: challenges for clinical sites.","authors":"Manon Pillai,&nbsp;Michelle M Davies,&nbsp;Fiona C Thistlethwaite","doi":"10.1177/2515135520944355","DOIUrl":"https://doi.org/10.1177/2515135520944355","url":null,"abstract":"<p><p>Advanced Therapy Medicinal Products (ATMPs) comprise novel cell, tissue and gene therapies and offer the potential of durable remissions for diseases where there is a high unmet clinical need. Once considered a niche area of academic research, ATMPs now represent one of the fastest-growing areas of clinical development. The field has seen a rapid expansion of academic and commercial entities successfully translating ATMP research into the clinic. This is reflected in projection that the global gene and cell therapy market will be worth US $11.96 billion by 2025. However, these treatments are complex to deliver and frequently do not fit naturally into established healthcare systems. In the United Kingdom (UK) there has been a long-standing interest in ATMP research and, in order to meet the ambition to act as an international hub of activity for delivery of ATMPs, a collaborative network of Advanced Therapy Treatment Centres (ATTCs) has been established. This review explores the challenges of delivery in the clinical setting, focussing on one form of ATMP, Adoptive Cell Therapy (ACT). We describe the strategy being implemented in the UK to optimise the roll-out of these exciting new therapies.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520944355"},"PeriodicalIF":0.0,"publicationDate":"2020-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2515135520944355","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38453253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 6
Evaluation of immunogenicity, safety and breakthrough following administration of live attenuated varicella vaccine in two doses three months apart regimen in Indian children. 对印度儿童接种水痘减毒活疫苗后的免疫原性、安全性和突破性进行评估,分两次接种,每次间隔三个月。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-08-11 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520937216
Monjori Mitra, Jaydeep Chowdhury, Surupa Basu, Partha Pratim Halder, Mallar Mukherjee, Archana Karadkhele, Gaurav Puppalwar, Rishi Jain
{"title":"Evaluation of immunogenicity, safety and breakthrough following administration of live attenuated varicella vaccine in two doses three months apart regimen in Indian children.","authors":"Monjori Mitra, Jaydeep Chowdhury, Surupa Basu, Partha Pratim Halder, Mallar Mukherjee, Archana Karadkhele, Gaurav Puppalwar, Rishi Jain","doi":"10.1177/2515135520937216","DOIUrl":"10.1177/2515135520937216","url":null,"abstract":"<p><strong>Background: </strong>In India, where varicella outbreaks are reported at a younger age, a two-dose vaccine schedule administered at an early age could be highly efficacious in preventing varicella infection. The aim of this study was to evaluate the immunogenicity and safety of live attenuated varicella vaccine (VR 795 Oka strain) in a two-dose, 3 months apart regimen.</p><p><strong>Methodology: </strong>Healthy children (⩾ 12 months and ⩽12 years; mean age: 4.4 years) of either sex were included. Geometric mean titers (GMT) were measured at baseline and 28 days post first- and second-dose, and seroprotection rates were measured 28 days post first and second dose. The incidence of breakthrough (BT) infections post vaccination was determined from 42 days post first and second dose of vaccine up to 12 months. Adverse events (AEs) were monitored and recorded throughout the study period.</p><p><strong>Results: </strong>Of 305 subjects enrolled, 217 were seronegative. The seroconversion rate (a change from a seronegative to a seropositive condition) was 93.3% post first-dose and 100% post two-doses. High levels (9 times) of GMT were reported since post first-dose to post second-dose in children aged 12-18 months, 18-60 months (99.43%); and in and above 60 months (99.02%). The extent of rise of anti-VZV IgG antibody titer post 28 days of first-dose at two-fold, three-fold and four-fold rise was 93.39%, 90.56% and 80.66%, respectively and 100% 4-fold rise post second-dose. A single case, a day after the first-dose of vaccination of mild BT infection, was observed after close contact with a severe case. AEs were mild and none of the serious AEs were related to the study drug.</p><p><strong>Conclusion: </strong>The two-dose schedule of varicella vaccine was safe and immunogenic when given 3 months apart. However, further comparative studies and follow up for both dosing schedules are needed to validate the advantage of early dosing.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520937216"},"PeriodicalIF":0.0,"publicationDate":"2020-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/84/55/10.1177_2515135520937216.PMC7425319.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38314199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
COVID-19: should oral vaccination strategies be given more consideration? COVID-19:是否应该更多地考虑口服疫苗接种策略?
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-07-27 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520946503
Aman Mehan, Ashwin Venkatesh, Milind Girish
{"title":"COVID-19: should oral vaccination strategies be given more consideration?","authors":"Aman Mehan,&nbsp;Ashwin Venkatesh,&nbsp;Milind Girish","doi":"10.1177/2515135520946503","DOIUrl":"https://doi.org/10.1177/2515135520946503","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). The novel coronavirus, SARS-CoV-2, has led to an unprecedented international health crisis. The implementation of a vaccine is essential to accelerate herd immunity, enabling lockdown measures to be relaxed and socioeconomic activity to safely resume whilst limiting the case fatality rate. A concerted global effort has led to over 150 vaccines currently under development. However, it is apparent that oral administration has been markedly under addressed as a potentially effective immunological strategy.","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520946503"},"PeriodicalIF":0.0,"publicationDate":"2020-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2515135520946503","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38259188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 22
Profile of adverse events following immunization with measles rubella vaccine at a tertiary care hospital in East Delhi, India. 在印度东德里的一家三级保健医院接种麻疹风疹疫苗后的不良事件概况。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-07-07 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520940131
Eshita Bhowmik, Aaradhana Singh, Ravi Sachan
{"title":"Profile of adverse events following immunization with measles rubella vaccine at a tertiary care hospital in East Delhi, India.","authors":"Eshita Bhowmik,&nbsp;Aaradhana Singh,&nbsp;Ravi Sachan","doi":"10.1177/2515135520940131","DOIUrl":"https://doi.org/10.1177/2515135520940131","url":null,"abstract":"<p><strong>Background: </strong>As a part of a measles and rubella (MR) campaign, the MR vaccine replaced the two-dose measles vaccine at 9-12 months and 16-24 months of age under the Universal Immunization Program (UIP). Although adverse events following immunization (AEFIs) following the measles and MMR vaccine at 9 months of age have been studied, AEFIs following the MR vaccine at 9 months of age have not been studied. As the MR vaccine a is very recent introduction in the UIP for routine immunization at 9 months of age, we intend to investigate the AEFI profile of MR vaccination at 9 months of age by active surveillance.</p><p><strong>Aim: </strong>We aimed to study the profile of the AEFIs with MR vaccine at 9-12 months of age in children vaccinated at the immunization clinic at the Pediatrics Department of a tertiary care hospital in East Delhi, India.</p><p><strong>Methods: </strong>Our study was a prospective observational study (telephonic survey). Children who attended Pediatrics OPD for the first dose of the MR vaccine at 9-12 months of age were enrolled in the study. Demographic details of the children who received the first dose of MR vaccine at 9-12 months of age at the immunization clinic of the hospital were recorded in a case record form. A telephone survey was conducted on day 7 and day 30 post-vaccination for AEFIs.</p><p><strong>Result: </strong>A total of 278 children were enrolled in the study, but 7 were unavailable for the further telephone survey. A total of 42 (15.5%) AEFIs were reported, of which 39 (94%) were in the initial 7 days and 3 (6%) were in the following 21 days following immunization. Of the AEFIs reported, the most common symptom was fever (38%), followed by upper respiratory tract infection (30.9%), local swelling at injection site (26.1%), and skin rash (4%).</p><p><strong>Conclusion: </strong>MR vaccine introduced in National Immunization Schedule is found to be safe for use in children except for a few minor reactions.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520940131"},"PeriodicalIF":0.0,"publicationDate":"2020-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2515135520940131","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38177559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
Development of vaccines against the sexually transmitted infections gonorrhoea, syphilis, Chlamydia, herpes simplex virus, human immunodeficiency virus and Zika virus. 淋病、梅毒、衣原体、单纯疱疹病毒、人类免疫缺陷病毒、寨卡病毒等性传播感染疫苗研制。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-06-27 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520923887
Edwin David G McIntosh
{"title":"Development of vaccines against the sexually transmitted infections gonorrhoea, syphilis, Chlamydia, herpes simplex virus, human immunodeficiency virus and Zika virus.","authors":"Edwin David G McIntosh","doi":"10.1177/2515135520923887","DOIUrl":"https://doi.org/10.1177/2515135520923887","url":null,"abstract":"<p><p>The success in preventing hepatitis B virus and human papillomavirus infections by means of vaccination paves the way for the development of other vaccines to prevent sexually transmitted infections (STIs) such as gonorrhoea, syphilis, chlamydia, herpes simplex virus, human immunodeficiency virus and Zika virus. The current status of vaccine development for these infections will be explored in this review. The general principles for success include the need for prevention of latency, persistence and repeat infections. A reduction in transmission of STIs would reduce the global burden of disease. Therapeutic activity of vaccines against STIs would be advantageous over preventative activity alone, and prevention of congenital and neonatal infections would be an added benefit. There would be an added value in the prevention of long-term consequences of STIs. It may be possible to re-purpose 'old' vaccines for new indications. One of the major challenges is the determination of the target populations for STI vaccination.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520923887"},"PeriodicalIF":0.0,"publicationDate":"2020-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2515135520923887","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38144339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 13
Transgenic T-cell receptor immunotherapy for cancer: building on clinical success. 癌症的转基因t细胞受体免疫疗法:建立在临床成功的基础上。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-06-22 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520933509
Natasha Oppermans, Gray Kueberuwa, Robert E Hawkins, John S Bridgeman
{"title":"Transgenic T-cell receptor immunotherapy for cancer: building on clinical success.","authors":"Natasha Oppermans,&nbsp;Gray Kueberuwa,&nbsp;Robert E Hawkins,&nbsp;John S Bridgeman","doi":"10.1177/2515135520933509","DOIUrl":"https://doi.org/10.1177/2515135520933509","url":null,"abstract":"<p><p>With the advent of immunotherapy as a realistic and promising option for cancer treatment, adoptive cellular therapies are gaining significant interest in the clinic. Whilst the recent successes of chimeric antigen receptor T-cell therapies for haematological malignancies are widely known, they have yet to show great success in solid cancers. However, immune cells transduced with T-cell receptors have been shown to traffic to and exert anti-cancer effects on solid tumour cells with some great successes. In this review, we explore the field of transgenic T-cell receptor immunotherapy, highlighting some of the key clinical trials which have paved the way for this type of cellular immunotherapy. Some trials have shown amazing clinical results, including long-term remissions and minimal toxicity, and can be looked at as an exemplar for this adoptive cell therapy. There have also been key trials where unexpected, fatal, off-tumour toxicity has occurred, and these trials have also been instrumental in shaping safer clinical trials, particularly regarding preclinical testing. In addition to previous trials, we analysed the current clinical trial space for T-cell receptor T-cell therapy, showing which trials are dominating in the clinic and which targets are being prioritised by researchers around the world. By looking at both past and current trials, we have been able to identify key drivers in developing transgenic T-cell receptor immunotherapy for the future.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520933509"},"PeriodicalIF":0.0,"publicationDate":"2020-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2515135520933509","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38114581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 8
CAR T-cell immunotherapy of B-cell malignancy: the story so far. b细胞恶性肿瘤的CAR - t细胞免疫疗法:迄今为止的故事。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-05-27 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520927164
Leena Halim, John Maher
{"title":"CAR T-cell immunotherapy of B-cell malignancy: the story so far.","authors":"Leena Halim, John Maher","doi":"10.1177/2515135520927164","DOIUrl":"10.1177/2515135520927164","url":null,"abstract":"<p><p>Chimeric antigen receptor (CAR) T-cell immunotherapy has achieved unprecedented efficacy in the treatment of chemotherapy-resistant or refractory B-cell malignancies. Promising results from pivotal anti-CD19 CAR T-cell phase II trials have led to landmark approvals of two CD19-specific CAR T-cell products by the United States Food and Drug Administration and European Medicines Agency. However, several issues associated with CAR T-cell treatment remain unresolved, such as the management of severe toxicities and the frequent occurrence of both antigen-positive and antigen-negative relapse. Nonetheless, pre-clinical research is advancing at an unprecedented pace to develop innovative solutions to address these issues. Herein, we summarise recent clinical developments and outcomes of CD19-targeted CAR T-cell immunotherapy and discuss emerging strategies that may further improve the success, safety and broadened applicability of this approach.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520927164"},"PeriodicalIF":0.0,"publicationDate":"2020-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/56/2e/10.1177_2515135520927164.PMC7257863.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38031872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults. 季节性三价灭活分离流感疫苗的安全性和免疫原性:一项在塞尔维亚健康成人中进行的双盲III期随机临床试验
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-05-25 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520925336
Goran Stevanovic, Aleksandar Obradovic, Snezana Ristic, Dragan Petrovic, Branislava Milenkovic, Danilo Mitrovic, Svetlana Filipovic Vignjevic, Katarina Ilic, Vera Stoiljkovic, Lidija Lavadinovic, Mijomir Pelemis, Svetlana Petrovic, Ana Vidmanic, Olga Popovic, Natasa Eremic, Erin Sparrow, Guido Torelli, Muriel Socquet, Renée Holt, Yordanka Ilieva-Borisova, Yuxiao Tang, Francesco Berlanda Scorza, Jorge Flores, Niraj Rathi
{"title":"Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults.","authors":"Goran Stevanovic,&nbsp;Aleksandar Obradovic,&nbsp;Snezana Ristic,&nbsp;Dragan Petrovic,&nbsp;Branislava Milenkovic,&nbsp;Danilo Mitrovic,&nbsp;Svetlana Filipovic Vignjevic,&nbsp;Katarina Ilic,&nbsp;Vera Stoiljkovic,&nbsp;Lidija Lavadinovic,&nbsp;Mijomir Pelemis,&nbsp;Svetlana Petrovic,&nbsp;Ana Vidmanic,&nbsp;Olga Popovic,&nbsp;Natasa Eremic,&nbsp;Erin Sparrow,&nbsp;Guido Torelli,&nbsp;Muriel Socquet,&nbsp;Renée Holt,&nbsp;Yordanka Ilieva-Borisova,&nbsp;Yuxiao Tang,&nbsp;Francesco Berlanda Scorza,&nbsp;Jorge Flores,&nbsp;Niraj Rathi","doi":"10.1177/2515135520925336","DOIUrl":"https://doi.org/10.1177/2515135520925336","url":null,"abstract":"<p><p>This study was a phase III, multicenter, double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a seasonal trivalent split, inactivated influenza vaccine (TIV) in healthy Serbian adults between the ages of 18 and 65 years. This egg-based vaccine was manufactured by the Institute of Virology, Vaccines and Sera, Torlak, Belgrade, Serbia. A total of 480 participants were assigned randomly in a ratio of 2:1 to receive a single intramuscular dose (0.5 ml) of the vaccine (15 µg of hemagglutinin per strain) or placebo (phosphate-buffered saline). Participants were monitored for safety, including solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs). No SAEs related to vaccination were reported. Injection site pain (51.3%), injection site tenderness (40.4%), tiredness (17.0%), and headache (15.1%) were the most commonly reported solicited events in the vaccine group. Incidence of related unsolicited AEs was low (1.3%) among vaccinees. Hemagglutinin inhibition (HAI) titers were measured before and 21 days after vaccination in 151 participants. Overall, HAI seroconversion rates to H1 and H3 were observed in 90.1% and 76.2% of vaccinees, respectively. For B antigen, it was 51.5%, likely due to high pre-vaccination titers. Post-vaccination seroprotection rates were in the range of 78.2-95.0% for the three antigens. Post-vaccination geometric mean titers (GMT) were at least 3.8 times higher than baseline levels for all the three strains among vaccinees. Overall, the study showed that the vaccine was safe and well tolerated, and induced a robust immune response against all three vaccine strains. ClinicalTrials.gov identifier: NCT02935192, October 17, 2016.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"8 ","pages":"2515135520925336"},"PeriodicalIF":0.0,"publicationDate":"2020-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2515135520925336","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38027493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Neisseria meningitidis: analysis of pili and LPS in emerging Brazilian strains. 脑膜炎奈瑟菌:巴西新菌株的纤毛和 LPS 分析。
Therapeutic Advances in Vaccines and Immunotherapy Pub Date : 2020-05-08 eCollection Date: 2020-01-01 DOI: 10.1177/2515135520919195
Amanda Izeli Portilho, Gabriela Trzewikoswki de Lima, Elizabeth De Gaspari
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