MTBVAC Tuberculosis Vaccine Enters Phase 2B Trial in South Africa, Kenya, and Tanzania
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PAARL, South Africa – The global effort to combat tuberculosis (TB) has reached a critical juncture wiht the commencement of a large-scale phase 2B clinical trial for the MTBVAC vaccine. On February 19, 2025, Biofabri, a Spanish biopharmaceutical company and a subsidiary of the Zendal Group and IAVI, announced the administration of the first doses of MTBVAC. This “Imagine” clinical trial, taking place at Be Part Research in Paarl, South Africa, represents a notable stride toward developing a more potent weapon against TB, the world’s deadliest infectious disease. IAVI, a nonprofit global research association, is sponsoring the trial.
The Imagine trial is a extensive study designed to evaluate the safety and efficacy of the MTBVAC vaccine. This Phase 2B trial is being conducted in South Africa, Kenya, and Tanzania, and its primary goal is to assess MTBVAC’s potential to prevent active pulmonary tuberculosis in both adolescents and adults. The study has received significant financial support from Open Philanthropy, the Gates Foundation, and the Federal Ministry of Education and Research of Germany through the KFW Advancement Bank, underscoring the global commitment to addressing this critical health challenge.
A Multi-Center study Across Three African Nations
The Imagine trial aims to enroll 4,300 participants with latent tuberculosis infection across 15 centers located in South Africa, Kenya, and tanzania. Participants will be closely monitored over a period of two to three years to rigorously evaluate the effectiveness of the MTBVAC candidate vaccine. The vaccine will be administered as a single dose via intradermal application.This extended monitoring period is essential for accurately assessing the vaccine’s long-term impact and identifying any potential side effects.
Mark Feinberg, president and CEO of IAVI, expressed his enthusiasm regarding the launch of the trial:
“We are excited to see the launch of the imagine essay. An innovative and effective vaccine against tuberculosis,the most lethal infectious disease in the world,would have a significant impact on global public health.This test marks a key milestone in global efforts to reduce the devastating impact of tuberculosis. We deeply appreciate the support of our financiers and partners, and, most importantly, of the volunteers who will participate in the essay.”
Mark feinberg, president and CEO of IAVI
The Urgent Need for a New Tuberculosis Vaccine
Tuberculosis continues to be a major global health threat, responsible for 1.25 million deaths in 2023 alone. The Bacillus Calmette-Guérin (BCG) vaccine, the only currently approved vaccine against TB, was introduced over a century ago. While BCG provides some protection to children, it is ineffective in preventing tuberculosis in adolescents and adults, highlighting the critical need for a more effective vaccine.
A new and effective tuberculosis vaccine for children,adolescents,and adults could potentially save millions of lives that would or else be lost to this devastating disease. The MTBVAC vaccine represents a promising step toward achieving this goal.
The Science Behind MTBVAC
The MTBVAC tuberculosis vaccine was designed by spanish researcher Carlos Martín, of the Universidad of Zaragoza, and brigitte gicquel, Ph.D.,of the Pasteur Institute. Biofabri of the Zendal Group industrially developed and licensed the vaccine.
MTBVAC is unique as the only attenuated live tuberculosis vaccine derived from Mycobacterium tuberculosis currently undergoing clinical trials. This is in contrast to the BCG vaccine, which is derived from Mycobacterium bovis, the bovine form of tuberculosis. This key difference could potentially lead to improved efficacy and broader protection against tuberculosis.
Previous Trials and Ongoing Research
MTBVAC has already been evaluated in two Phase 2 clinical trials involving adults and newborns, demonstrating comparable or favorable immunogenicity and safety profiles compared to the BCG vaccine across various doses. Biofabri is also conducting a Phase 3 clinical study of the MTBVAC vaccine in newborns in South Africa, Madagascar, and Senegal.
As of January 2024,Biofabri and the HIV Vaccine Trials Network have been conducting a Phase 2a clinical study to assess MTBVAC’s safety and immunogenicity in individuals with and without HIV. This study is especially vital, as individuals with HIV are at a significantly higher risk of developing active tuberculosis.
Lewis Schrager, director of Vaccine Development against IAVI tuberculosis, emphasized the potential impact of MTBVAC:
“The Imagine essay is a new and important effort to develop a vaccine capable of fighting the most fatal disease in the world.As MTBVAC is a single -dose vaccine, it has the potential to prevent millions of cases of tuberculosis if it demonstrates its effectiveness especially in communities of tough access around the world.”
Lewis Schrager, director of vaccine Development against IAVI tuberculosis
Ensuring Global Access and Affordability
If MTBVAC proves to be effective, Biofabri, IAVI, and thier partners are committed to ensuring a sufficient and affordable supply of the vaccine, particularly in low- and middle-income countries where the burden of tuberculosis is highest.
Esteban Rodríguez, CEO of Biofabri, stated:
“Biofabri together with its partners in Asia and South America will guarantee the global vaccine supply. As soon as MTBVAC proves to be safe and effective, biofabri, together with our partners we have established a strategy to ensure that the vaccine is manufactured and supplies in sufficient amounts to newborns, adolescents and adults and is accessible and at affordable prices in income countries medium and low.”
Esteban Rodríguez, CEO of Biofabri
The launch of the Phase 2B trial for the MTBVAC vaccine represents a significant step forward in the global fight against tuberculosis.With its unique approach and promising early results, MTBVAC offers hope for a future where TB is no longer a leading cause of death worldwide. The collaborative efforts of researchers,funders,and global health organizations are crucial to ensuring that this potentially life-saving vaccine reaches those who need it most.
MTBVAC: Groundbreaking Tuberculosis Vaccine—Hope on the Horizon?
Tuberculosis (TB) remains a leading cause of death globally, claiming millions of lives annually and significantly reducing the gross domestic product in low- and middle-income countries. The Imagine trial has launched a phase 2B study of MTBVAC, a novel tuberculosis vaccine, across South Africa, Kenya, and Tanzania. This single-dose vaccine targets latent TB infection, offering potential for global impact. The trial aims to enroll 4,300 participants with latent TB infection (LTBI) to assess MTBVAC’s ability to prevent progression to active TB.
Tuberculosis not only causes millions of deaths each year but also significantly reduces the gross domestic product in low- and middle-income countries, as it disproportionately affects young and economically active individuals. even after prosperous treatment, patients frequently enough suffer lasting lung damage, making tuberculosis a leading cause of pulmonary disability in many endemic countries.
Moreover, the emergence of drug-resistant tuberculosis poses a significant threat to global control efforts, requiring more complex and expensive treatment regimens.
Dr. Keertan Dheda, professor of respiratory medicine, director of the center of Lung and immunity infection, head of the division of Pneumology in the Department of Medicine of the University of Cape, and principal researcher of the Imagine essay, highlighted the transformative potential of MTBVAC:
An effective vaccine against tuberculosis is urgently needed, historically the greatest cause of deaths in humanity, which causes 11 million new cases of the disease every year.Along with the millions of deaths, tuberculosis is also associated with a significant reduction in the gross domestic product in low and medium -sized income countries, since young and economically active people are usually the most affected by the disease. Even after an effective treatment, patients They frequently enough suffer damage and scars on the lungs, so tuberculosis is the most common and critically important cause of disability pulmonary in many endemic countries. Conversely, medication resistant tuberculosis is an emerging threat to control tuberculosis that is arduous and most expensive to treat.Thus, I am delighted to be part of the MTBVAC essay, which has the potential to transform the lives and economies of millions of people and dozens of countries.Dr. keertan Dheda, professor of respiratory medicine
ana Céspedes, Director of Operations of IAVI, emphasized the collaborative nature of the Imagine trial:
The Imagine trial is an exciting step forward in the investigation of vaccines against tuberculosis. This effort has been possible thanks to the global collaboration between IAVI with Biofabri and the University of Zaragoza, and the Consortium of Partners in the centers of South Africa, Kenya and Tanzania.We are working towards the same common goal: the end of the devastating impacts of tuberculosis disease. It is an honor to be part of this coalition to promote the development of a new vaccine against tuberculosis and guarantee its global distribution in an equitable and affordable way onc it is authorized.Ana Céspedes, Director of Operations of IAVI
Conclusion: A Promising Step Towards Ending tuberculosis
The launch of the Imagine trial and the administration of the first doses of the MTBVAC vaccine represent a significant milestone in the global effort to combat tuberculosis. With its unique design, rigorous testing, and commitment to global access, MTBVAC holds the potential to transform the lives of millions and contribute to a future free from the devastating impacts of tuberculosis. The results of this trial will be eagerly awaited by the global health community.
MTBVAC: could This New TB Vaccine Finally Turn the Tide Against a Global Killer?
Tuberculosis (TB) remains a leading cause of death worldwide, but could a new vaccine finally offer lasting hope? The answer may lie with MTBVAC, a promising candidate currently undergoing large-scale trials.
Interviewer: Dr. Anya Sharma, welcome. You’re a leading expert in vaccinology and infectious disease research. The recent launch of the Phase 2B clinical trial for the MTBVAC tuberculosis vaccine has generated considerable excitement. Could you begin by explaining what makes MTBVAC unique and why it represents such a meaningful development in the fight against TB?
dr. Sharma: Thank you for having me. The excitement surrounding MTBVAC is absolutely justified. For decades, the Bacillus Calmette-Guérin (BCG) vaccine has been our primary weapon against TB, yet its effectiveness is limited, notably in preventing pulmonary TB in adolescents and adults. MTBVAC’s uniqueness stems from its derivation from Mycobacterium tuberculosis itself, rather than the bovine form used in BCG. This crucial difference holds the potential for considerably enhanced efficacy and broader protection across different age groups. The fact that it’s designed as a single-dose vaccine also simplifies management, improving practicality, especially in resource-limited settings where TB is moast prevalent. The use of a live attenuated vaccine, carefully weakened too be safe yet still immunogenic, also leverages the body’s natural immune response more robustly than manny other vaccine approaches, making it potentially more effective at preventing disease.
Interviewer: The Imagine trial, spanning several countries in Africa, is a significant undertaking. What are the key objectives of this phase of research and what are the challenges researchers face?
Dr. Sharma: The Imagine trial’s primary goal is to rigorously assess MTBVAC’s safety and efficacy in preventing active pulmonary TB in adolescents and adults.To achieve this, they’re meticulously monitoring a large cohort of participants with latent TB infection (LTBI) over an extended period.The challenges involve several factors. Firstly, conducting large-scale clinical trials in diverse populations across multiple countries requires refined logistical planning and resource management. Secondly, ensuring consistent data collection and participant adherence to the study protocols is essential. Thirdly, analyzing the long-term effects of the vaccine requires patience and meticulous data analysis. The sheer scale of the project itself, involving thousands of participants, is a significant undertaking requiring a massive collaborative effort. Moreover, given that TB is a complex infection with diverse strains, the effectiveness of the vaccine on different strains is an significant consideration.
Interviewer: The article mentions previous trials showing promising results. Can you summarize these findings and explain what they tell us about MTBVAC’s potential?
Dr. Sharma: Previous Phase 2 trials have indeed demonstrated encouraging results, indicating comparable or even better immunogenicity and safety profiles compared to the BCG vaccine. This provides valuable preliminary data supporting the advancement to large-scale Phase 2B and Phase 3 trials. These earlier successes show promising levels of immune response in participants after receiving the vaccine, reinforcing its potential effectiveness. Tho, it’s crucial to remember that these were smaller trials and the results need to be independently verified through the larger, more extensive, clinical trials currently underway.
Interviewer: What are the broader implications if MTBVAC proves to be effective in preventing TB?
Dr.Sharma: A successful MTBVAC vaccine would have a transformative, potentially life-saving impact globally. TB is not just a health crisis; it’s an economic one,severely impacting low- and middle-income countries. An effective, affordable vaccine could significantly reduce the disease burden, saving millions of lives and boosting economic productivity. It would also help reduce the spread of drug-resistant TB, a particularly risky variant that is difficult and expensive to treat and has a high morbidity rate. Effective disease prevention is always preferable to treatment, and the potential to prevent this disease entirely in vulnerable groups would be a significant boon globally.
Interviewer: What are the next steps and what might we expect to see in the coming years concerning MTBVAC?
Dr. Sharma: The next crucial step is the completion of the ongoing Phase 2B and Phase 3 trials. The data collected from these trials will be meticulously analyzed to determine MTBVAC’s efficacy and safety profile comprehensively. Upon successful completion and regulatory approval, the focus will then shift towards manufacturing and distribution of the vaccine on a global scale, ensuring equitable access particularly in regions with a high burden of disease. This will also include planning for vaccination campaigns and related educational programs. In the coming years, we may expect to see improved TB control measures across the globe.
Interviewer: What is yoru overall assessment of MTBVAC’s potential to revolutionize TB control?
Dr. Sharma: MTBVAC represents a substantial advancement in the field of tuberculosis prevention. Its unique approach and promising results from preliminary trials offer a real beacon of hope for millions at risk. Although large-scale trials still need to confirm its effectiveness, the potential for a safe and highly effective TB vaccine is substantial. The collaborative efforts of researchers, funders, and global health organizations are vital in ensuring that this potentially life-saving vaccine becomes widely accessible. Its impact may be far-reaching – impacting not only public health but also the global economy in very positive ways.
concluding thoughts: MTBVAC’s journey toward becoming a widely available vaccine is ongoing. Let the discourse continue! Share your thoughts and insights below, and engage with us in the comments section. Your contributions empower scientific progress.