Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.

开始日期2021-05-03

申办/合作机构

PT Bio Farma

[+1]

NCT03933098 / Unknown status临床3期IIT

A Phase III Multicenter, Observer-Blinded, Randomized, Active Controlled, Immune Non-inferiority and Safety Study of Vi-DT Vaccine Compared to Typbar TCV® in Healthy 6 Months-45 Years Aged Nepalese Participants.

This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose.
The study objectives are:
I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT)
II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.

开始日期2019-11-15

申办/合作机构

International Vaccine Institute

[+1]

NCT03527355 / Completed临床2期IIT

A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers

This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose.
The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age.
The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.

开始日期2018-04-18

申办/合作机构

International Vaccine Institute

[+2]

100 项与 Typhoid conjugate vaccine(International Vaccine Institute) 相关的临床结果

登录后查看更多信息

100 项与 Typhoid conjugate vaccine(International Vaccine Institute) 相关的转化医学

登录后查看更多信息

100 项与 Typhoid conjugate vaccine(International Vaccine Institute) 相关的专利（医药）

登录后查看更多信息

项与 Typhoid conjugate vaccine(International Vaccine Institute) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Single and two-dose typhoid conjugate vaccine safety and immunogenicity in HIV-exposed uninfected and HIV-unexposed uninfected Malawian children

Article

作者: Jamka, Leslie P. ; Nampota-Nkomba, Nginache ; Patel, Priyanka D. ; Laurens, Matthew B. ; Mapemba, Victoria ; Ndaferankhande, John M. ; Mwakiseghile, Felistas ; Neuzil, Kathleen M. ; Heyderman, Robert S. ; Banda, Happy ; Masonga, Rhoda ; Datta, Shrimati ; Pasetti, Marcela F. ; Gordon, Melita A. ; Hosangadi, Divya ; Patel, Pratiksha ; Wachepa, Richard ; Misiri, Theresa ; Oshinsky, Jennifer ; Lipenga, Bright ; Nyirenda, Osward M.

Vaccine safety and immunogenicity data in human immunodeficiency virus (HIV)-exposed uninfected (HEU) children are important for decision-making in HIV and typhoid co-endemic countries. In an open-label study, we recruited Malawian HEU and HIV unexposed uninfected (HUU) infants aged 9 - 11 months. HEU participants were randomized to receive Vi-tetanus toxoid conjugate vaccine (Vi-TT) at 9 months, Vi-TT at 15 months, or Vi-TT at 9 and 15 months. HUU participants received Vi-TT at 9 and 15 months. Safety outcomes included solicited and unsolicited adverse events (AE) and serious AEs (SAEs) within 7 days, 28 days, and 6 months of vaccination, respectively. Serum was collected before and at day 28 after each vaccination to measure anti-Vi IgG antibodies by enzyme-linked immunosorbent assay (ELISA). Cohort 1 (66 participants) enrollment began 02 December 2019, and follow-up was terminated before completion due to the COVID-19 pandemic. Cohort 2 (100 participants) enrollment began 25 March 2020. Solicited AEs were mostly mild, with no significant differences between HEU and HUU participants or one- and two-dose groups. All six SAEs were unrelated to vaccination. Anti-Vi geometric mean titers (GMT) increased significantly from 4.1 to 4.6 ELISA units (EU)/mL at baseline to 2572.0 - 4117.6 EU/mL on day 28 post-vaccination, and similarly between HEU and HUU participants for both one- and two-dose schedules. All participants seroconverted (>4-fold increase in GMT) by the final study visit. Our findings of comparable safety and immunogenicity of Vi-TT in HUU and HEU children support country introductions with single-dose Vi-TT in HIV-endemic countries.

2024-12-31·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of conjugate vaccine for typhoid (Vi-DT): Finding from an observer-blind, active-controlled, randomized, non-inferiority, phase III clinical trial among healthy volunteers

Article

作者: Tamrakar, Rajendra ; Gupta, Birendra Prasad ; Khadgi, Amit ; Tamrakar, Dipesh ; Shrestha, Anmol ; Rai, Ganesh Kumar ; Saluja, Tarun ; Thapa, Pragya ; Poudel, Pranodan ; Madhup, Surendra ; Singh, Srijana ; Shrestha, Rajeev ; Sahastrabuddhe, Sushant ; Thapa, Sameera

Typhoid fever is a significant public health concern with most of the sufferers between 15 and 25 y of age in Nepal. We undertook this study to demonstrate Vi polysaccharide conjugated with diphtheria toxoid (Vi-DT) conjugate vaccine which is non-inferior to Typbar typhoid conjugate vaccine, a Vi polysaccharide vaccine conjugated with tetanus toxoid (Vi-TT) with a focus on the adult population from Dhulikhel Hospital which was one of the total four sites in Nepal. In this study, we assigned the eligible participants in 1:1:1:1 ratio by block randomization, and stratified into three age groups (6 months to less than 2 y, 2 y to less than 18 y, and 18 y to 45 y), allotted to Group A, B, C, and D. Group A, B, and C received 25 μg (0.5 mL) of Vi-DT study vaccine and participants in Group D received 25 μg (0.5 mL) Vi-TT vaccine. We descriptively analyzed safety in all the participants receiving one dose of the investigational vaccine. The anti-Vi-IgG seroconversion rate in Vi-DT recipients was 99.71% (97.5% CI 98.04-99.96; 344 of 345 participants) and 99.13% (94.27-99.87; 114 of 115) in Vi-TT recipients which indicates that Vi-DT vaccine is non-inferior to Vi-TT vaccine. In safety aspect, 16.81% of total subject had at least one solicited adverse reaction and 22.61% of the Vi-TT participants experienced at least one solicited adverse reaction with most of them being local adverse reactions. None of the enrolled participants reported serious adverse events. Our study shows that a single dose of the Vi-DT vaccine is immunogenic, safe to administer and non-inferior to the Vi-TT vaccine four weeks after vaccination.

2024-03-01·Vaccine

Immune responses to typhoid conjugate vaccine in a two dose schedule among Nepalese children <2 years of age

Article

作者: Pollard, Andrew J ; Pokhrel, Bhishma ; Shakya, Mila ; Jones, Elizabeth ; Hill, Matilda ; Bista, Sabitri ; Gurung, Meeru ; Maskey, Himang ; Sah, Ganesh Prasad ; Kim, Young Chan ; Atherton, Rachel ; O'reilly, Peter ; Voysey, Merryn ; Shrestha, Sonu ; Nyland, Katherine Theiss ; Pant, Dikshya ; Shrestha, Shrijana ; Basnyat, Buddha ; Mujadidi, Yama F ; Mclean, Florence ; Kelly, Sarah ; Dhakal, Babita ; Maskey, Pratistha ; Bijukchhe, Sanjeev M ; Rajkarkinar, Shristy

BACKGROUNDPreviously, the Vi-typhoid conjugate vaccine (Vi-TT) was found to be highly efficacious in Nepalese children under 16 years of age. We assessed the immunogenicity of Vi-TT at 9 and 12 months of age and response to a booster dose at 15 months of age.METHODSInfants were recruited at Patan Hospital, Kathmandu and received an initial dose of Vi-TT at 9 or 12 months of age with a booster dose at 15 months of age. Blood was taken at four timepoints, and antibody titres were measured using a commercial ELISA kit. The primary study outcome was seroconversion (4-fold rise in antibody titre) of IgG one month after both the doses.FINDINGSFifty children were recruited to each study group.Some visits were disrupted by the COVID19 pandemic and occurred out of protocol windows.Both the study groups attained 100 % IgG seroconversion after the initial dose. IgG seroconversion in the 9-month group was significantly higher than in the 12-month group (68.42 % vs 25.8 %, p < 0.001). Among individuals who attended visits per protocol, IgG seroconversion after the first dose occurred in 100 % of individuals (n = 27/27 in 9-month and n = 32/32 in 12-month group). However, seroconversion rates after the second dose were 80 % in the 9-month and 0 % in the shorter dose-interval 12-month group (p < 0.001) (n = 16/20 and n = 0/8, respectively).INTERPRETATIONVi-TT is highly immunogenic at both 9 and 12 months of age. Stronger response to a booster in the 9-month group is likely due to the longer interval between doses.

项与 Typhoid conjugate vaccine(International Vaccine Institute) 相关的新闻（医药）

2024-02-26

·Pharmaceutical Technology

SK bioscience’s typhoid vaccine receives WHO prequalification

SK bioscience developed the SKYTyphoid vaccine along with the International Vaccine Institute (IVI). Credit: SK bioscience. SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving prequalification (PQ) certification from the World Health Organization (WHO). This is the fourth WHO PQ for the company, following certifications for two influenza vaccines and a varicella vaccine. The WHO PQ system is a rigorous process that ensures the safety and efficacy of vaccines by assessing their manufacturing process, quality and clinical trial data. The development of SKYTyphoid was a collaborative effort with the International Vaccine Institute (IVI) and received support from the Bill & Melinda Gates Foundation. SKYTyphoid employs the purified Vi polysaccharide-diphtheria toxoid conjugate method, which is safe for infants and children aged six months to two years. See Also: Neurocrine Biosciences sees highest patent filings and grants during December in Q4 2023 Caribou Biosciences sees highest patent filings and grants during November in Q4 2023 It provides comparable immunogenicity and long-term protection with a single dose, as against current oral live or polysaccharide typhoid vaccines. In 2022, SKYTyphoid obtained an export licence from the Korean Ministry of Food and Drug Safety, following a global clinical trial. The Phase III study involved 2,160 subjects aged six months to 45 years in Nepal, showcasing a favourable immunogenicity and safety profile. The results indicated that SKYTyphoid’s performance was on par with another WHO PQ-certified polysaccharide-protein conjugate typhoid vaccine. SK bioscience CEO Jaeyong Ahn stated: “We are pleased that our global collaboration to address the global vaccine supply imbalance and improve public health has been recognised by the WHO PQ certification. “We will make every effort to rapidly supply SKYTyphoid by obtaining approvals in countries.” With the WHO PQ designation, SK bioscience is set to target global markets, focusing on public procurement in typhoid-endemic countries with high demand. IVI director general Dr Jerome Kim stated: “Typhoid fever is more prevalent in warmer temperatures, and climate change and the worrying rise of antimicrobial resistance are only adding to the threat of the disease. Vaccination is critical to effective prevention and control of the disease. In collaboration with SK bioscience and other partners, IVI will continue endeavours to make this vaccine accessible to people who need it the most.”

疫苗临床3期临床结果

2024-02-23

·PRNewswire

SK bioscience Receives WHO Prequalification for Typhoid Conjugate Vaccine

SKYTyphoid is jointly developed with the International Vaccine Institute, supported by the Bill & Melinda Gates Foundation. WHO PQ paves the way for public procurement by UN organizations. SK bioscience plans to target global markets with SKYTyphoid by seeking approvals in various countries. SEONGNAM, South Korea, Feb. 23, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the company has obtained prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine (TCV), 'SKYTyphoid®' (project name NBP618). This the fourth WHO PQ the company has received following its two influenza vaccines and varicella vaccine. Continue Reading SK bioscience receives WHO prequalification for typhoid conjugate caccine. SK bioscience plans to target global markets with SKYTyphoid by seeking approvals in various countries. The WHO PQ system evaluates the manufacturing process, quality, and clinical trial results of a vaccine according to strict criteria to certify its safety and efficacy. The tested vaccine must comply with stringent procedures, including: examination of technical documents, including clinical and quality data, testing of sample quality, inspection of manufacturing facilities to ensure adherence to Good Manufacturing Practices (GMP) and quality control standards. SKYTyphoid was jointly developed with the International Vaccine Institute (IVI) and is supported by the Bill & Melinda Gates Foundation. This vaccine utilizes the 'purified Vi polysaccharide-diphtheria toxoid conjugate' method, which conjugates a polysaccharide of typhoid bacteria, serving as an antigen, to a diphtheria toxin protein (diphtheria toxoid), that acts as a carrier. Utilizing this conjugate technology, the vaccine can be safely administered to infants and children aged 6 months to 2 years. It is anticipated to offer comparable immunogenicity and long-term protection with a single dose, compared to existing oral live or polysaccharide typhoid vaccines. SKYTyphoid has received an export license from the Korean Ministry of Food and Drug Safety in 2022, based on the results of a global clinical study. The Phase III study, which enrolled 2,160 participants ranging from toddlers aged 6 months to individuals aged 45 years in Nepal, demonstrated a positive immunogenicity and safety profile of SKYTyphoid. Compared to the existing polysaccharide-protein conjugate typhoid vaccine with WHO PQ certification, SKYTyphoid showed comparable immunogenicity and safety profile across all age groups. These findings were published in The Lancet Infectious Disease, a sister journal to Lancet[1]. With WHO PQ, SK bioscience plans to target global markets with SKYTyphoid, focusing on public procurement markets, including major typhoid-endemic countries with high demands. According to the WHO, there are between 11 to 20 million typhoid fever cases reported worldwide each year, resulting in approximately 120,000 to 160,000 deaths. Jaeyong Ahn, CEO of SK bioscience, said, "We are pleased that our global collaboration to address the global vaccine supply imbalance and improve public health has been recognized by the WHO PQ certification," adding, "We will make every effort to rapidly supply SKYTyphoid by obtaining approvals in countries." Dr. Jerome Kim, Director General of IVI said, "Typhoid fever is more prevalent in warmer temperatures, and climate change and the worrying rise of antimicrobial resistance are only adding to the threat of the disease. Vaccination is critical to effective prevention and control of the disease. In collaboration with SK bioscience and other partners, IVI will continue endeavors to make this vaccine accessible to people who need it the most." About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed in vaccine development and manufacturing to enable more equitable access of vaccines in the world. In leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin([email protected]) Jeannie S. Pak([email protected]) SOURCE SK bioscience

疫苗临床结果临床3期紧急使用授权

2023-08-24

·PRNewswire

SK bioscience and Vaxxas Enter Joint Development Agreement for Needle-Free Patch Delivery of Typhoid Vaccine

SK bioscience and Vaxxas have officially entered into a Joint Development Agreement. This collaboration is set to revolutionize vaccine delivery by developing a novel vaccine-delivery device combination product using Vaxxas' high-density microarray patch (HD-MAP) platform technology with SK bioscience's proprietary typhoid vaccine. This groundbreaking initiative receives support from the esteemed global charitable foundation, Wellcome. The HD-MAP platform technology offers user-friendly vaccines, allowing possible self-administration. Its room temperature stability revolutionizes distribution, reducing costs and expanding vaccination access, particularly in lower- to middle-income countries. SEONGNAM, South Korea, Aug. 23, 2023 /PRNewswire/ -- SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the company has entered into a collaboration agreement with Vaxxas, an Australian biotechnology company developing a unique vaccine patch platform technology, to develop a second-generation typhoid conjugate vaccine with support from Wellcome. Continue Reading SK bioscience and Vaxxas Enter Joint Development Agreement for Needle-Free Patch Delivery of Typhoid Vaccine. SK bioscience's SKYTyphoid™ vaccine will be reformulated so that it can be 'printed' onto the thousands of tiny microprojections covering the Vaxxas patch to be delivered directly to the abundant immune cells just under the skin surface. This reformulation aims to enhance access and broaden markets where traditional intramuscular delivery using needle and syringe has been employed. Under the agreement, SK bioscience will supply the antigen utilized by its typhoid conjugate vaccine, SKYTyhpoid™ that was jointly developed by SK bioscience and the International Vaccine Institute (IVI). Vaxxas will be responsible for reformulating the SKYTyphoid antigen so that it can be applied to its proprietary HD-MAPs, and then conduct preclinical studies, which if successful, will be followed by a Phase I human clinical trial. The project is expected to be completed within two years from initiation to reporting the data from the Phase I clinical trial. The project is being supported by approximately AU$5.4 million (GB£2.84 million / US$3.67 million) in grant funding received from Wellcome. Wellcome is a global charitable foundation supporting discovery research into life, health and wellbeing, and action to take on mental health, infectious disease and climate and health. Their infectious disease programme supports projects to help increase understanding of the sources of disease and drivers of escalation, as well as accessible and affordable solutions to control the impact of infections. SK bioscience collaborated with Wellcome and the IVI on the development of a trivalent invasive non-typhoidal Salmonellosis vaccine candidate in 2019. In October 2022, SK bioscience also signed a memorandum of understanding (MoU) with Hilleman Laboratories, a research institute established by MSD and Wellcome, for a strategic partnership to co-develop new vaccine candidates and technology platforms. As Vaxxas' HD-MAPs deliver the vaccine directly to abundant immune cells in the skin, they hold the potential to be more immunogenic than traditional needle and syringe administration, and they offer the prospect of reduced dosing. Vaxxas' user-friendly applicator facilitates simplified self-administration accommodating individuals with varying skill levels. Vaxxas' innovation to reformulate vaccines for application on HD-MAPs and subsequent drying can prevent drug deterioration and improve vaccine stability. This could allow storing and distributing vaccines at room temperatures, which is vital for making vaccines more accessible in lower- and middle- income countries with limited cold-chain distribution infrastructure. SKYTyphoid is a polysaccharide-protein conjugate (Vi-DT) vaccine, formulated by conjugating the polysaccharide of Typhi, which serves as an antigen, to diphtheria toxin protein, which serves as a carrier. SK bioscience received funding to develop SKYTyphoid from the Bill & Melinda Gates Foundation in the early stages of the development. Based on its immunogenicity and safety, SKYTyphoid obtained an approval for exportation from the Ministry of Food and Drug Safety (MFDS) in May 2022, and is expected to obtain WHO Prequalification this year. Compared to a current polysaccharide vaccine, SKYTyphoid provides acceptable immunogenicity and long-term preventive effects with a single-dose administration. Furthermore, the vaccine can be administered to infants 6 months to 2 years of age. Typhoid fever is a life-threatening infection caused by the bacterium Salmonella Typhi. It is usually spread through contaminated food or water. The disease continues to be a public health problem in many developing countries in Africa, Middle East, and Southeast where there is a continuing lack of clean water supply and lack of adequate sewage facilities. According to the World Health Organization, an estimated 9 million cases of typhoid fever occur globally each year. Symptoms include prolonged high fever, fatigue, headache, nausea, abdominal pain, and constipation or diarrhea with mortality rates up to 30%.[1] Pierre Balard, Senior Research Manager at Wellcome said, "To help protect more people at risk from deadly diseases like typhoid fever, new vaccine innovations are needed to improve access and ensure equitable coverage. Vaxxas' high-density microarray patch (HD-MAP) is an important step in this direction. With the potential to overcome some of the most enduring barriers to vaccine access in lower income countries, this product could be a vital addition to our global toolkit." David L. Hoey, President and CEO of Vaxxas said "We are excited to be initiating this important work with Wellcome and SK bioscience to leverage our HD-MAP vaccine platform to potentially enhance typhoid vaccination. We believe our HD-MAP can play a critical role in extending the global reach of typhoid conjugate vaccines, and make a significant difference to the lives of many." Jaeyong Ahn, CEO of SK bioscience said, "Typhoid fever is a dangerous disease that frequently occurs in low- and middle- income countries, but the utilization of typhoid vaccines has been limited due to the requirement for vaccines that remain stable under varying temperatures and those that can be administered without medical supervision. This collaboration with Vaxxas provides an opportunity to overcome those challenges. We will continue to develop various formulations and products that can contribute to human health based on cross-border cooperation with international organizations and institutions, such as Wellcome and Vaxxas." Notes to editors Vaxxas and SK biosciences have recognised that Wellcome is supporting the project in order to address the burden of infectious diseases (such as typhoid) by developing new treatments which are affordable and available to those most in need, whilst also being commercially viable for the companies involved. As a condition of Wellcome's funding, future commercialisation of any typhoid product developed with this funding will be subject to global access requirements to allow low- and middle-income countries to access those products. A share of any revenue from future private commercial sales of the respective product (not public and/or Gavi supplies) will also come back to Wellcome for further investment in science to solve urgent health challenges. About SK bioscience SK bioscience is a global innovative vaccine and biotech company, standing committed to global pandemic preparedness in vaccine development and manufacturing to create more equitable access to vaccines. In leveraging strengths on cutting-edge vaccine development technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. Under collaborations of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, SK bioscience has firmly established globally certified R&D and manufacturing technologies. All of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. For further information, please visit - Official SK bioscience Homepage - SK bioscience Linkedin About Vaxxas Vaxxas is a private Australian company, focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious disease and oncology, and currently has six clinical programs, including ones focused on Covid-19, Influenza and Measles Rubella. Vaxxas' core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ's commercialisation group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners, Brandon BioCatalyst, and US-based HealthCare Ventures, followed by further financing led by OneVentures with UQ joining the most recent financing. OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government's Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at vaxxas.com and . About Wellcome Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we're taking on three worldwide health challenges: mental health, infectious disease and climate and health. Contact SK bioscience Communications Team Changhyun Jin([email protected]) Jeannie S. Pak([email protected]) Tae-Gyun Kim([email protected]) Wellcome Media Office [email protected] +44 (0)20 7611 8866 [1] Typhoid, the World Health Organization SOURCE SK bioscience