Latest news with #MarkFeinberg
Yahoo
26-02-2025
- Health
- Yahoo
IAVI and Biofabri/Zendal Announce First Vaccinations in the IMAGINE Clinical Trial, a Large-scale Safety and Efficacy Trial of the Tuberculosis Vaccine Candidate MTBVAC
Tuberculosis (TB) is the world's deadliest infectious disease, killing 1.25 million people in 2023. MTBVAC is a promising vaccine candidate being evaluated in the IMAGINE trial, a large-scale safety and efficacy trial evaluating the prevention of TB disease in adolescents and adults with latent TB infection in South Africa, Kenya, and Tanzania. NEW YORK, NY AND PORRIÑO, SPAIN / / February 26, 2025 / IAVI, a global nonprofit scientific research organization, and the Spanish biopharmaceutical company Biofabri, a subsidiary of Zendal, today announced that the first doses of MTBVAC have been administered in the IMAGINE (Investigation of MTBVAC toward Accelerating Global Immunization for a Neglected Epidemic) clinical trial. The trial's first participants were vaccinated on February 19, 2025, at Be Part Research (Pty) Limited in Paarl, South Africa. The IMAGINE trial is a large-scale safety and efficacy clinical trial of the TB vaccine candidate MTBVAC. The study, sponsored by IAVI, is funded by Open Philanthropy, the Gates Foundation, and the German Federal Ministry of Education and Research through the KfW Development Bank. The IMAGINE trial will assess the safety and efficacy of MTBVAC to prevent active TB lung disease in adolescents and adults. This Phase 2b trial is expected to enroll approximately 4,300 participants with latent TB infection across 15 sites in South Africa, Kenya, and Tanzania. Study participants will be followed for two to three years to assess the vaccine candidate's efficacy. MTBVAC is administered as a single dose via intradermal delivery. "We are thrilled to see the launch of the IMAGINE trial," said IAVI President and CEO Mark Feinberg, M.D., Ph.D. "A new and efficacious vaccine against TB, the world's deadliest infectious disease, would have tremendous public health impact. This trial represents a very important milestone in global efforts to mitigate the terrible impact of the TB pandemic, and we are very grateful for the support of our funders and partners, and, importantly, the study volunteers who will participate in the IMAGINE trial." TB disease caused 1.25 million deaths in 2023 and is widely recognized as the world's most lethal infectious disease. The only approved vaccine for TB, the Bacillus Calmette-Guérin (BCG) vaccine, was introduced over 100 years ago. The BCG vaccine provides partial protection to children but does not prevent TB disease in adolescents or adults. A TB vaccine effective in children, adolescents, and adults would save millions of lives otherwise lost to TB over time. MTBVAC was designed by the Spanish researcher Carlos Martin, from the University of Zaragoza, and Brigitte Gicquel, Ph.D., of Institut Pasteur, and was industrially developed and in-licensed by Biofabri (Zendal Group). It is the only live-attenuated TB vaccine candidate derived from Mycobacterium tuberculosis in current trials. This is a notable difference from BCG, which is derived from Mycobacterium bovis, the bovine form of tuberculosis. MTBVAC has been evaluated in two Phase 2 trials in adults and neonates and was shown to have either comparable or favorable immunogenicity and safety profiles at different doses as compared to BCG. Biofabri is also conducting a Phase 3 trial of MTBVAC in neonates in South Africa, Madagascar, and Senegal. Biofabri and the HIV Vaccines Trial Network are also conducting a Phase 2a trial evaluating the safety and immunogenicity of MTBVAC in people living with and without HIV that began in January 2024. "The IMAGINE trial is an important new effort to develop a vaccine capable of combatting the world's deadliest disease," said Lewis Schrager, M.D., head of IAVI's TB vaccine development efforts. "Because MTBVAC is a single-shot vaccine we are hopeful that, if proven effective, MTBVAC could prevent millions of cases of TB disease, particularly in persons living in some of the world's most difficult-to-reach locations." If MTBVAC is shown to be efficacious, Biofabri, IAVI, and other partners will work together to ensure there is a sufficient, affordable supply of MTBVAC available for low- and middle-income countries. "Biofabri and its partners in Asia and South America will work together to help ensure a global supply of the vaccine," said Esteban Rodriguez, CEO of Biofabri. "An effective vaccine is urgently needed for TB, historically the biggest killer of mankind, which results in 11 million newly diseased individuals every year. Besides the millions of resultant deaths, TB is also associated with substantial reductions in the gross domestic product of low- and middle-income countries, given that economically active young people are often affected by the disease. Even after effective treatment patients often suffer lung damage and scarring, and thus TB is the most common and important cause of lung disability in many TB endemic countries. Drug-resistant TB is an emerging threat to TB control that is difficult and more expensive to treat. I am therefore delighted to be part of the MTBVAC trial, which has the potential to transform the lives and economies of millions of people and dozens of countries," said Keertan Dheda, MBBCh, FCP, FCCP, Ph.D, FRCP, professor of respiratory medicine, director of the Centre for Lung Infection and Immunity, head of the Division of Pulmonology in the Department of Medicine at the University of Cape Town, and principal investigator for the IMAGINE trial. "The IMAGINE trial is an exciting step forward for TB vaccine research. This effort has been made possible by a global collaboration between IAVI, our Spanish partners Biofabri and the University of Zaragoza, and our trial site partners in South Africa, Kenya, and Tanzania. We are working towards the same common goal: the end of the devastating impacts of TB disease. We are honored to be part of this coalition to ensure an accelerated R&D push for a new TB vaccine and its equitable, affordable global distribution once authorized," said Ana Céspedes, Pharm.D., MBA, and COO of IAVI. The study will be conducted at the following clinical research sites: Kenya Medical Research Institute/Center for Respiratory Disease Research in Nairobi, Kenya; the Victoria Biomedical Research Institute in Kisumu, Kenya; Ifakara Health Institute in Dar es Salaam, Tanzania; The Aurum Institute in Rustenburg, South Africa; The Aurum Institute in Tembisa, South Africa; Be Part Research in Paarl, South Africa; Centre for Infectious Diseases Research in Africa, in Cape Town, South Africa; JOSHA Research in Bloemfontein, South Africa; Perinatal HIV Research Unit in Soweto, South Africa; South African Tuberculosis Vaccine Initiative in Worcester, South Africa; Synergy Biomedical Research Institute in East London, South Africa; TASK Delft in Cape Town, South Africa; TASK Eden in George, South Africa; University of Cape Town Lung Institute - Centre for Tuberculosis Research Innovation in Cape Town, South Africa; and the University of Cape Town Lung Institute - Centre for Lung Infection and Immunity in Cape Town, South Africa. MTBVAC MTBVAC is being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG in newborns, and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine. Two Phase 2 trials of MTBVAC have been completed, one sponsored by Biofabri and supported by the European and Developing Countries Clinical Trials Partnership in infants in South Africa, and one sponsored by IAVI and supported by the U.S. National Institutes of Health and the U.S. Department of Defense through its Congressionally Directed Medical Research Program. Results for both trials are expected to be published in 2025. IAVI. IAVI is a nonprofit scientific research organization with locations in the U.S., Europe, Africa, and India that develops vaccines and antibodies for HIV, TB, emerging infectious diseases, and neglected diseases, with the goal of providing global access. It has contributed to efforts to evaluate most of the leading TB vaccine candidates now in clinical development and has a highly experienced TB vaccine clinical research team in South Africa. Biofabri. Biofabri is a biopharmaceutical company created in 2008 with the aim of researching, developing, and manufacturing vaccines for humans. Biofabri has extensive technical and scientific capacity in vaccines and immunotherapy. Biofabri belongs to the Zendal group, a Spanish pharmaceutical business group made up of six companies specializing in the development, manufacture and marketing of vaccines and other biotechnological products for human and animal health. UNIZAR. The University of Zaragoza, Spain, is the main center for technological innovation in the Ebro Valley. It participates in different exchange programs, collaborating with universities and research centers in Europe, Latin America, and the United States. Microbiologists from the university associated with Centro de Investigación Biomédica en Red Enfermadades Respiratorias led the research and subsequent discovery of the experimental vaccine MTBVAC. Within the TuBerculosis Vaccine Initiative consortium, the MTBVAC discovery phase has included rigorous clinical characterization by independent laboratories and research groups. IAVI Media ContactHeather TeixeiraHteixeira@ Biofabri Media ContactBeatriz Diaz SOURCE: IAVI View the original press release on ACCESS Newswire Sign in to access your portfolio
Associated Press
26-02-2025
- Health
- Associated Press
IAVI and Biofabri/Zendal Announce First Vaccinations in the IMAGINE Clinical Trial, a Large-scale Safety and Efficacy Trial of the Tuberculosis Vaccine Candidate MTBVAC
Tuberculosis (TB) is the world's deadliest infectious disease, killing 1.25 million people in 2023. MTBVAC is a promising vaccine candidate being evaluated in the IMAGINE trial, a large-scale safety and efficacy trial evaluating the prevention of TB disease in adolescents and adults with latent TB infection in South Africa, Kenya, and Tanzania. NEW YORK, NY AND PORRIÑO, SPAIN / ACCESS Newswire / February 26, 2025 / IAVI, a global nonprofit scientific research organization, and the Spanish biopharmaceutical company Biofabri, a subsidiary of Zendal, today announced that the first doses of MTBVAC have been administered in the IMAGINE (Investigation of MTBVAC toward Accelerating Global Immunization for a Neglected Epidemic) clinical trial. The trial's first participants were vaccinated on February 19, 2025, at Be Part Research (Pty) Limited in Paarl, South Africa. The IMAGINE trial is a large-scale safety and efficacy clinical trial of the TB vaccine candidate MTBVAC. The study, sponsored by IAVI, is funded by Open Philanthropy, the Gates Foundation, and the German Federal Ministry of Education and Research through the KfW Development Bank. The IMAGINE trial will assess the safety and efficacy of MTBVAC to prevent active TB lung disease in adolescents and adults. This Phase 2b trial is expected to enroll approximately 4,300 participants with latent TB infection across 15 sites in South Africa, Kenya, and Tanzania. Study participants will be followed for two to three years to assess the vaccine candidate's efficacy. MTBVAC is administered as a single dose via intradermal delivery. 'We are thrilled to see the launch of the IMAGINE trial,' said IAVI President and CEO Mark Feinberg, M.D., Ph.D. 'A new and efficacious vaccine against TB, the world's deadliest infectious disease, would have tremendous public health impact. This trial represents a very important milestone in global efforts to mitigate the terrible impact of the TB pandemic, and we are very grateful for the support of our funders and partners, and, importantly, the study volunteers who will participate in the IMAGINE trial.' TB disease caused 1.25 million deaths in 2023 and is widely recognized as the world's most lethal infectious disease. The only approved vaccine for TB, the Bacillus Calmette-Guérin (BCG) vaccine, was introduced over 100 years ago. The BCG vaccine provides partial protection to children but does not prevent TB disease in adolescents or adults. A TB vaccine effective in children, adolescents, and adults would save millions of lives otherwise lost to TB over time. MTBVAC was designed by the Spanish researcher Carlos Martin, from the University of Zaragoza, and Brigitte Gicquel, Ph.D., of Institut Pasteur, and was industrially developed and in-licensed by Biofabri (Zendal Group). It is the only live-attenuated TB vaccine candidate derived from Mycobacterium tuberculosis in current trials. This is a notable difference from BCG, which is derived from Mycobacterium bovis, the bovine form of tuberculosis. MTBVAC has been evaluated in two Phase 2 trials in adults and neonates and was shown to have either comparable or favorable immunogenicity and safety profiles at different doses as compared to BCG. Biofabri is also conducting a Phase 3 trial of MTBVAC in neonates in South Africa, Madagascar, and Senegal. Biofabri and the HIV Vaccines Trial Network are also conducting a Phase 2a trial evaluating the safety and immunogenicity of MTBVAC in people living with and without HIV that began in January 2024. 'The IMAGINE trial is an important new effort to develop a vaccine capable of combatting the world's deadliest disease,' said Lewis Schrager, M.D., head of IAVI's TB vaccine development efforts. 'Because MTBVAC is a single-shot vaccine we are hopeful that, if proven effective, MTBVAC could prevent millions of cases of TB disease, particularly in persons living in some of the world's most difficult-to-reach locations.' If MTBVAC is shown to be efficacious, Biofabri, IAVI, and other partners will work together to ensure there is a sufficient, affordable supply of MTBVAC available for low- and middle-income countries. 'Biofabri and its partners in Asia and South America will work together to help ensure a global supply of the vaccine,' said Esteban Rodriguez, CEO of Biofabri. 'An effective vaccine is urgently needed for TB, historically the biggest killer of mankind, which results in 11 million newly diseased individuals every year. Besides the millions of resultant deaths, TB is also associated with substantial reductions in the gross domestic product of low- and middle-income countries, given that economically active young people are often affected by the disease. Even after effective treatment patients often suffer lung damage and scarring, and thus TB is the most common and important cause of lung disability in many TB endemic countries. Drug-resistant TB is an emerging threat to TB control that is difficult and more expensive to treat. I am therefore delighted to be part of the MTBVAC trial, which has the potential to transform the lives and economies of millions of people and dozens of countries,' said Keertan Dheda, MBBCh, FCP, FCCP, Ph.D, FRCP, professor of respiratory medicine, director of the Centre for Lung Infection and Immunity, head of the Division of Pulmonology in the Department of Medicine at the University of Cape Town, and principal investigator for the IMAGINE trial. 'The IMAGINE trial is an exciting step forward for TB vaccine research. This effort has been made possible by a global collaboration between IAVI, our Spanish partners Biofabri and the University of Zaragoza, and our trial site partners in South Africa, Kenya, and Tanzania. We are working towards the same common goal: the end of the devastating impacts of TB disease. We are honored to be part of this coalition to ensure an accelerated R&D push for a new TB vaccine and its equitable, affordable global distribution once authorized,' said Ana Céspedes, Pharm.D., MBA, and COO of IAVI. The study will be conducted at the following clinical research sites: Kenya Medical Research Institute/Center for Respiratory Disease Research in Nairobi, Kenya; the Victoria Biomedical Research Institute in Kisumu, Kenya; Ifakara Health Institute in Dar es Salaam, Tanzania; The Aurum Institute in Rustenburg, South Africa; The Aurum Institute in Tembisa, South Africa; Be Part Research in Paarl, South Africa; Centre for Infectious Diseases Research in Africa, in Cape Town, South Africa; JOSHA Research in Bloemfontein, South Africa; Perinatal HIV Research Unit in Soweto, South Africa; South African Tuberculosis Vaccine Initiative in Worcester, South Africa; Synergy Biomedical Research Institute in East London, South Africa; TASK Delft in Cape Town, South Africa; TASK Eden in George, South Africa; University of Cape Town Lung Institute - Centre for Tuberculosis Research Innovation in Cape Town, South Africa; and the University of Cape Town Lung Institute - Centre for Lung Infection and Immunity in Cape Town, South Africa. MTBVAC MTBVAC is being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG in newborns, and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine. Two Phase 2 trials of MTBVAC have been completed, one sponsored by Biofabri and supported by the European and Developing Countries Clinical Trials Partnership in infants in South Africa, and one sponsored by IAVI and supported by the U.S. National Institutes of Health and the U.S. Department of Defense through its Congressionally Directed Medical Research Program. Results for both trials are expected to be published in 2025. IAVI. IAVI is a nonprofit scientific research organization with locations in the U.S., Europe, Africa, and India that develops vaccines and antibodies for HIV, TB, emerging infectious diseases, and neglected diseases, with the goal of providing global access. It has contributed to efforts to evaluate most of the leading TB vaccine candidates now in clinical development and has a highly experienced TB vaccine clinical research team in South Africa. Biofabri. Biofabri is a biopharmaceutical company created in 2008 with the aim of researching, developing, and manufacturing vaccines for humans. Biofabri has extensive technical and scientific capacity in vaccines and immunotherapy. Biofabri belongs to the Zendal group, a Spanish pharmaceutical business group made up of six companies specializing in the development, manufacture and marketing of vaccines and other biotechnological products for human and animal health. UNIZAR. The University of Zaragoza, Spain, is the main center for technological innovation in the Ebro Valley. It participates in different exchange programs, collaborating with universities and research centers in Europe, Latin America, and the United States. Microbiologists from the university associated with Centro de Investigación Biomédica en Red Enfermadades Respiratorias led the research and subsequent discovery of the experimental vaccine MTBVAC. Within the TuBerculosis Vaccine Initiative consortium, the MTBVAC discovery phase has included rigorous clinical characterization by independent laboratories and research groups.
Yahoo
04-02-2025
- Health
- Yahoo
WHO prioritises IAVI Sudan Ebola vaccine ring trial amid Uganda outbreak
A Sudan Ebola vaccine, provided by the International AIDS Vaccine Initiative (IAVI), is being investigated in a Uganda vaccine trial that was launched just four days after the country declared an outbreak. The vaccine is being investigated as part of a ring trial led by the World Health Organization (WHO) at Makerere University Lung Institute in the Ugandan capital, Kampala. Evaluation of the recombinant vesicular stomatitis virus (rVSV) vaccine has been prioritised as part of a global collaborative effort supporting the country's Ebolavirus outbreak. Principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI), with support from WHO and other partners, including Uganda's Ministry of Health, prepared the randomised trial to begin the first dosing just four days after the outbreak was confirmed on 30 January. Dosing began at the Mulago Referral Hospital in the capital yesterday (3 February) after three vaccination rings were defined. The first ring involves approximately 40 contacts from the first reported and confirmed case, a health worker who died on 29 January. The efficacy of ring trials was established in a study published in the New England Journal of Medicine, which evaluated trials of MSD's rVSV vaccine Ervebo that was investigated in the Zaire Ebola outbreak in the Democratic Republic of Congo. IAVI president Dr Mark Feinberg said: 'We believe this clinical trial represents an important step toward evaluating the potential of IAVI's vaccine to protect exposed individuals from Ebola Sudan infection, as well as demonstrating its value as a safe, effective, and accessible new tool to include in comprehensive outbreak responses in the future. "Critically, having vaccine doses readily available in the country made it possible for us all to mobilise in just days and to be able to incorporate the evaluation of a promising Ebola Sudan vaccine clinical trial into the public health response very soon after the first reports of the current outbreak.' This will be the first trial to assess the clinical efficacy of a vaccine against Ebola disease due to the Sudan virus. In 2023, IAVI initiated a Phase I trial (NCT05724472) which determined the rVSV Ebola Sudan vaccine was well tolerated with immune responses detected in all groups. This data was shared in November 2024 during the annual meeting American Society of Tropical Medicine and Hygiene. IAVI is also investigating the rVSV platform technology elsewhere in its portfolio, including a Lassa virus vaccine candidate currently in Phase II trials in West Africa. Evaluation of IAVI's Ebola Sudan vaccine was already prepositioned in the country, however, the recent outbreak has seen the WHO sign an agreement for IAVI to provide more doses of the shot. The most recent Ebola outbreak is the sixth the country has faced, the last being in 2022. The virus causes severe haemorrhagic fever disease and holds a fatality rate of between 41% and 70%. Although several promising candidate medical countermeasures are progressing through clinical development, there are no vaccines or therapeutics approved for Ebola Sudan. Ebola Zaire vaccines are not effective in protecting against Ebola Sudan. During the 2022 outbreak, a randomised protocol for candidate vaccines was developed with teams trained in good clinical practice (GCP) and standard operating procedures of how to run studies during a national outbreak. Staff completed refresher training in recent days. WHO colleagues experienced in trials and ring vaccination arrived in Uganda over the weekend to support the trial implementation and GCP compliance. According to GlobalData's Pharmaceutical Intelligence Centre, there are 16 Ebola drugs in active clinical development, ten in Phase I, two in Phase II, and four in Phase III. Just one of the Phase III candidates, a combination of Johnson and Johnson's Mvabea and Zabdeno, is being investigated in Ebola Sudan. The Mvebea and Zabdeno regiment is approved for the Zaire ebolavirus. GlobalData is the parent company of Clinical Trials Arena. "WHO prioritises IAVI Sudan Ebola vaccine ring trial amid Uganda outbreak" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
