Fifth Global Forum on TB Vaccines

Transcription

1 Media coverage Fifth Global Forum on TB Vaccines The Hindi HEALTH Experts urge more funds to tackle Tuberculosis crisis SPECIAL CORRESPONDENT NEW DELHI, FEBRUARY 20, :31 IST 4.2 lakh Indians die of the disease every year Stating that tuberculosis (TB) has become a national crisis in India, the Health Ministry assured the TB community that eliminating the disease by 2025 had the highest level of commitment from the Prime Minister Narendra Modi s office. Senior Health Ministry official Sunil Khaparde, who heads the TB programme voiced the assurance at the opening day of the 5th Global Forum on TB Vaccines in New Delhi.

2 Nearly 4.2 lakh Indians die of TB every year. Out of the 10 million cases globally, India shoulders the maximum burden with 2.8 million cases. According to Health Ministry data, only 63% of the patients infected with the airborne disease are currently under treatment. Further, 1,47,000 patients are resistant to first and second line TB medicines. At the current rate of progress, global targets to eliminate TB by 2030 will be missed by a 150 years. Against this backdrop, Dr Soumya Swaminathan, deputy director general of the World Health Organisation (WHO) said that globally, governments need to invest more in TB research and development to meet the global targets. WHO representative to India Hendrick Bekedam added that TB vaccine was a global public health good, which meant governments need to invest if they want to own it later. Business Standard Two new vaccines may be effective in preventing TB: Study IANS New Delhi Last Updated at February 20, :45 IST Two new vaccines have shown promise in preventing tuberculosis, the world's leading infectious disease killer, results of new clinical trials show. The findings showed that re-vaccination with the Bacille Calmette-Guerin (BCG) vaccine and an experimental vaccine candidate named as H4:IC31, were effective in preventing sustained infections in high-risk adolescents. Introduced in 1921, BCG is the only licensed tuberculosis vaccine available globally, while H4:IC31 is an investigative subunit vaccine candidate being developed. "We have demonstrated that (this) vaccination has the potential to reduce the rate of sustained tuberculosis infection in a high-transmission setting," said lead author Mark Hatherill, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town. "While neither vaccine proved to be statistically significant in preventing an initial tuberculosis infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained tuberculosis infections.

3 "The results will provide significant scientific benefit to the field in understanding tuberculosis infection, and we look forward to testing the potential of such vaccines to prevent tuberculosis disease among uninfected adolescents," Hatherill said. According to the Global TB Report 2017, released by the World Health Organisation (WHO), India continues to have the highest number of tuberculosis (TB) cases in the world. In 2016, there were an estimated 10.4 million new tuberculosis cases worldwide. Seven countries accounted for 64 per cent of the total burden, with India having the maximum number of tuberculosis patients, followed by Indonesia, China, Philippines, Pakistan, Nigeria and South Africa. In India, an estimated 27.9 lakh patients were suffering from tuberculosis in 2016 and up to 4.23 lakh patients were estimated to have died during the year, the report said. The study, presented at the Fifth Global Forum on TB Vaccines in New Delhi, involved 990 HIV-negative, healthy adolescents (12-17 years of age) who had been vaccinated as infants with BCG. All participants were randomised evenly into three study arms: placebo, H4:IC31, or BCG revaccination. The data showed that both vaccines appeared to be safe and produced an immune response in the adolescents studied. No vaccine-related serious adverse events were reported. As per WHO, about one-third of the world's population has what is called a latent tuberculosis infection, which means people have been infected by tuberculosis bacteria but are not (yet) ill with the disease and cannot transmit the disease. People infected with tuberculosis bacteria have a lifetime risk of falling ill with tuberculosis.people ill with tuberculosis can infect other people through close contact over the course of a year. The Indian Express

4 TB vaccination: New study rekindles hope to prevent sustained infections The research is being considered as a significant leap in controlling tuberculosis (TB), which kills around 4.8 lakh Indians every year and more than 1,400 every day. The research is being considered as a significant leap in controlling tuberculosis (TB), which kills around 4.8 lakh Indians every year and more than 1,400 every day. (File photo) Repeat vaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduces sustained TB infections in adolescents, results of a clinical trial in South Africa have shown. Introduced in 1921, BCG is the only vaccine currently licensed to prevent TB. The results of the phase II clinical trial will be presented at the 5th Global Forum on TB Vaccines that starts in Delhi tomorrow and will be inaugurated by science and technology minister Dr Harshvardhan in present of WHO DDG Soumya Swaminathan and others. In the prevention-of-infection Phase 2 trial conducted in Western Cape province of South Africa, the experimental vaccine candidate, H4:IC31, also reduced sustained infections, although not at statistically significant levels. However, the trend observed for H4:IC31 is the first time a a vaccine candidate has shown efficacy in protection against TB infection or disease in humans.

5 TB kills an estimated 480,000 Indians every year and more than 1,400 every day. According to the World Health Organization (WHO), about one-third of the world s population has what is called a latent TB infection, which means people have been infected by TB bacteria but are not ill with the disease and cannot transmit the disease. People infected with TB bacteria have a lifetime risk of falling ill with TB of 10 percent. People ill with TB can infect other people through close contact over the course of a year. Earlier studies have indicated that there may be possible benefits of re-vaccination with BCG but this is the first proof of concept trial. Mark Hatherill, MD, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town, and the study s principal investigator, said: We are pleased to have performed the first-known randomized, placebo-controlled prevention-of-infection trial for TB and to have demonstrated that vaccination has the potential to reduce the rate of sustained TB infection in a high-transmission setting. While neither vaccine proved to be statistically significant in preventing an initial TB infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained TB infections. We believe the results from this novel trial design will provide significant scientific benefit to the field in understanding TB infection, and based on this positive signal, we look forward to testing the potential of such vaccines to prevent TB disease among uninfected adolescents in a larger, more traditional prevention-of-disease clinical trial. The study involved 990 HIV-negative, healthy adolescents (12 to 17 years of age) who had been vaccinated as infants with BCG. All participants were randomized evenly into three study arms: placebo, H4:IC31, or BCG revaccination. All participants were screened to ensure they were not infected with Mycobacterium tuberculosis (Mtb) prior to vaccination in the study. The data showed that both vaccines appeared to be safe and produced an immune response in the adolescents studied. No vaccine-related serious adverse events were reported in the study, and the most common vaccine-related adverse event was injection site swelling in BCG revaccinated participants, typical for BCG vaccination. The Week Two new vaccines show promise in preventing TB By Namita Kohli February 20, 2018

6 Two new vaccine candidates have shown promise in preventing TB infections, results of new clinical trials show. In a prevention-of-infection Phase II trial conducted in South Africa, re-vaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents. BCG is the world's only commercially available TB vaccine, and prevents some form of TB, but not pulmonary TB. Another vaccine candidate, an experimental one H4:IC31 also reduced sustained infections, although not at statistically significant levels. However, the trend observed for H4:IC31 is the first time a subunit vaccine (vaccines that use only one part of the disease-causing virus) has shown any indication of protecting against TB infection or disease in humans. The announcement of the encouraging results from the innovative clinical trials was made on Monday by Aeras, a nonprofit organisation dedicated to developing vaccines against tuberculosis (TB). The study evaluated H4:IC31 vaccination and BCG re-vaccination for "safety, immunogenicity and the ability to prevent initial and sustained TB infections" among healthy adolescents in the Western Cape Province of South Africa. H4:IC31 is an investigative sub-unit vaccine candidate that is being jointly developed by Aeras and Sanofi Pasteur, the vaccines business of Sanofi, and the Statens Serum Institut. The clinical trial was conducted at SATVI and at the Emavundleni Research Centre (part of the Desmond Tutu HIV Centre in the University of Cape Town, Africa). It

7 was funded by Sanofi Pasteur, the United Kingdom s Department for International Development, The Bill & Melinda Gates Foundation and Aeras. READ MORE No country for babies: 6 lakh newborns die within 28 days in India annually SFIO to probe Fortis, Religare for alleged irregularities What to keep in mind while undergoing an MRI scan Fortis promoters Malvinder, Shivinder Singh resign from board Proposed health insurance scheme to cost Rs crore Over the past decade, more than a dozen new TB vaccine candidates have been tested in human clinical trials around the world.. Mark Hatherill, MD, director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town, and the study s principal investigator, said, We are pleased to have performed the first-known randomised, placebo-controlled prevention-of-infection trial for TB and to have demonstrated that vaccination has the potential to reduce the rate of sustained TB infection in a high-transmission setting. While neither vaccine has proved to be statistically significant in preventing an initial TB infection, Hatherill insisted that the signals were extremely encouraging. We believe the results from this novel trial design will provide significant scientific benefit to the field in understanding TB infection, and based on this positive signal, we look forward to testing the potential of such vaccines to prevent TB disease among uninfected adolescents in a larger, more traditional prevention-of-disease clinical trial. Aeras would be presenting the detailed results of the study at the 5th Global Forum for TB Vaccines that starts on February 20 in the capital. According to the World Health Organisation (WHO), about one-third of the world's population has "latent TB infection". This means that people have been infected by TB bacteria but are not yet ill with the disease, and cannot transmit the disease. People infected with TB bacteria have a 10 per cent lifetime risk of falling ill with TB. Those ill with TB can infect other people through close contact over the course of a year. India has the highest burden of TB in the world, and the government is targeting to eliminate the disease by Technology Networks Tuberculosis Vaccine Trial Results Offer Potential for BCG Revaccination

8 NEWS Feb 20, 2018 Aeras, a nonprofit organization dedicated to developing vaccines against tuberculosis (TB), today announced results from an innovative clinical trial that provides encouraging new evidence that TB vaccines could prevent sustained infections in highrisk adolescents. In a prevention-of-infection Phase 2 trial conducted in South Africa, revaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents. An experimental vaccine candidate, H4:IC31, also reduced sustained infections, although not at statistically significant levels. However, the trend observed for H4:IC31 is the first time a subunit vaccine has shown any indication of ability to protect against TB infection or disease in humans. TB infections that developed during the study were determined using a QuantiFERON -TB Gold in Tube (QFT-GIT) test, a commercially available blood test that helps diagnose TB infections. In the trial, individuals who tested negative for QFTrate by which GIT were considered to not have a TB infection. The trial measured the individuals converted to QFT-GIT positive, implying evidence of TB infection. Those individuals who tested QFT-GIT positive consecutively over 6 months were considered to have a sustained infection. The results will be presented at the 5th Global Forum on TB Vaccines in New Delhi, India. According to the World Health Organization (WHO), about one-third of the world's population has what is called a latent TB infection, which means people have been infected by TB bacteria but are not (yet) ill with the disease and cannot transmit the disease. People infected with TB bacteria have a lifetime risk of falling ill with TB of 10

9 percent. People ill with TB can infect other people through close contact over the course of a year. Without proper treatment, 45% of HIV-negative people with TB on average and nearly all HIV-positive people with TB will die. Mark Hatherill, MD, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town, and the study s principal investigator, said: We are pleased to have performed the first-known randomized, placebo-controlled prevention-of-infection trial for TB and to have demonstrated that vaccination has the potential to reduce the rate of sustained TB infection in a high-transmission setting. While neither vaccine proved to be statistically significant in preventing an initial TB infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained TB infections. We believe the results from this novel trial design will provide significant scientific benefit to the field in understanding TB infection, and based on this positive signal, we look forward to testing the potential of such vaccines to prevent TB disease among uninfected adolescents in a larger, more traditional prevention-of-disease clinical trial. The study evaluated H4:IC31 vaccination and BCG revaccination for safety, immunogenicity and the ability to prevent initial and sustained TB infections among healthy adolescents in the Western Cape Province of South Africa. H4:IC31 is an investigative subunit vaccine candidate being developed jointly by Aeras and Sanofi Pasteur, the vaccines business of Sanofi (EURONEXT: SAN) (NYSE: SNY), and the Statens Serum Institut. BCG is the only licensed tuberculosis vaccine available globally. The clinical trial was conducted at SATVI and at the Emavundleni Research Centre (part of the Desmond Tutu HIV Centre). It was funded by Sanofi Pasteur, the United Kingdom s Department for International Development, The Bill & Melinda Gates Foundation and Aeras. The study was approved by the Medicines Control Council of South Africa and the relevant local independent ethics committees. Linda-Gail Bekker, MD, PhD, a lead investigator for the trial, the Chief Operating Officer at the Desmond Tutu HIV Foundation and President of the International AIDS Society, said: We would like to thank all the study participants and their families for participating in this novel clinical trial. We believe the results are important and warrant further investigation into other subunit vaccines and a reevaluation of BCG revaccination as a potential strategy to prevent TB in high-incidence countries. An effective TB vaccine remains an urgent global goal. Jacqui Shea, PhD, CEO of Aeras, stated: New TB vaccines are essential to end this deadly epidemic, especially with the rise of drug-resistant strains. In this innovative study, we not only observed important results for BCG, we also saw the first early efficacy signal against infection to be shown by a subunit TB vaccine candidate (H4:IC31). Further, we established that the novel prevention-of-infection trial design has the potential to provide evidence of a biological signal earlier and at lower cost than traditionally designed TB vaccine prevention of disease efficacy studies. The data collected will inform the next series of clinical studies as well as enable the search for correlates of protection against sustained infection. Later this year, Aeras and its partners

10 look forward to announcing primary results from a Phase 2b prevention of disease trial with M72/AS01E, another subunit vaccine candidate, and to commencing two Phase 2 clinical trials with an additional, promising subunit vaccine candidate. This article has been republished from materials provided by Aeras. Note: material may have been edited for length and content. For further information, please contact the cited source. Pharmabiz.com Clinical Trials + Font Resize - Phase 2 TB vaccine trial shows potential for new BCG revaccination strategies Our Bureau, Mumbai Wednesday, February 21, 2018, 09:00 Hrs [IST] Aeras, a nonprofit organization dedicated to developing vaccines against tuberculosis (TB), announced results from an innovative clinical trial that provides encouraging new evidence that TB vaccines could prevent sustained infections in high-risk adolescents. In a prevention-of-infection phase 2 trial conducted in South Africa, revaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents. An experimental vaccine candidate, H4:IC31, also reduced sustained infections, although not at statistically significant levels. However, the trend observed for H4:IC31 is the first time a subunit vaccine has shown any indication of ability to protect against TB infection or disease in humans. TB infections that developed during the study were determined using a QuantiFERON-TB Gold in Tube (QFT-GIT) test, a commercially available blood test that helps diagnose TB infections. In the trial, individuals who tested negative for QFT-GIT were considered to not have a TB infection. The trial measured the rate by which individuals converted to QFT-GIT positive, implying evidence of TB infection. Those individuals who tested QFT-GIT positive consecutively over 6 months were considered to have a sustained infection. According to the World Health Organization (WHO), about one-third of the world's population has what is called a latent TB infection, which means people have been infected by TB bacteria but are not (yet) ill with the disease and cannot transmit the disease. People infected with TB bacteria have a lifetime risk of falling ill with TB of 10 percent. People ill with TB can infect 10

11 15 other people through close contact over the course of a year. Without proper treatment, 45% of HIV-negative people with TB on average and nearly all HIV-positive people with TB will die. Mark Hatherill, MD, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town, and the study s principal investigator, said: We are pleased to have performed the first-known randomized, placebo-controlled prevention-of-infection trial for TB and to have demonstrated that vaccination has the potential to reduce the rate of sustained TB infection in a high-transmission setting. While neither vaccine proved to be statistically significant in preventing an initial TB infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained TB infections. We believe the results from this novel trial design will provide significant scientific benefit to the field in understanding TB infection, and based on this positive signal, we look forward to testing the potential of such vaccines to prevent TB disease among uninfected adolescents in a larger, more traditional prevention-of-disease clinical trial. The study evaluated H4:IC31 vaccination and BCG revaccination for safety, immunogenicity and the ability to prevent initial and sustained TB infections among healthy adolescents in the Western Cape Province of South Africa. H4:IC31 is an investigative subunit vaccine candidate being developed jointly by Aeras and Sanofi Pasteur, the vaccines business of Sanofi, and the Statens Serum Institut. BCG is the only licensed tuberculosis vaccine available globally. The clinical trial was conducted at SATVI and at the Emavundleni Research Centre (part of the Desmond Tutu HIV Centre). It was funded by Sanofi Pasteur, the United Kingdom s Department for International Development, The Bill & Melinda Gates Foundation and Aeras. The study was approved by the Medicines Control Council of South Africa and the relevant local independent ethics committees. Linda-Gail Bekker, MD, PhD, a lead investigator for the trial, the Chief Operating Officer at the Desmond Tutu HIV Foundation and President of the International AIDS Society, said: We would like to thank all the study participants and their families for participating in this novel clinical trial. We believe the results are important and warrant further investigation into other subunit vaccines and a reevaluation of BCG revaccination as a potential strategy to prevent TB in high-incidence countries. An effective TB vaccine remains an urgent global goal. Jacqui Shea, PhD, CEO of Aeras, stated: New TB vaccines are essential to end this deadly epidemic, especially with the rise of drug-resistant strains. In this innovative study, we not only observed important results for BCG, we also saw the first early efficacy signal against infection to be shown by a subunit TB vaccine candidate (H4:IC31). Further, we established that the novel prevention-of-infection trial design has the potential to provide evidence of a biological signal earlier and at lower cost than traditionally designed TB vaccine prevention of disease efficacy studies. The data collected will inform the next series of clinical studies as well as enable the search for correlates of protection against sustained infection. Later this year, Aeras and its partners look forward to announcing primary results from a phase 2b prevention of disease trial with M72/AS01E, another subunit vaccine candidate, and to commencing two phase 2 clinical trials with an additional, promising subunit vaccine candidate. The study involved 990 HIV-negative, healthy adolescents (12 to 17 years of age) who had been

12 vaccinated as infants with BCG. All participants were randomized evenly into three study arms: placebo, H4:IC31, or BCG revaccination. All participants were screened to ensure they were not infected with Mycobacterium tuberculosis (Mtb) prior to vaccination in the study. At the outset of this innovative proof-of-concept study, statistical significance was set at one-sided p<0.1 to favor the risk of observing a false positive efficacy signal rather than a false negative. The data showed that both vaccines appeared to be safe and produced an immune response in the adolescents studied. No vaccine-related serious adverse events were reported in the study, and the most common vaccine-related adverse event was injection site swelling in BCG revaccinated participants, typical for BCG vaccination. For the primary efficacy endpoint, 134 participants tested positive for an initial Mtb infection as measured by QFT-GIT conversion from negative to positive (placebo=49; BCG=41; H4:IC31=44). When compared to placebo, neither vaccine achieved statistical significance in preventing an initial QFT-GIT conversion. Observed vaccine efficacy was 20.1% (p=0.15) for BCG revaccination and 9.4% (p=0.32) for H4:IC31. For the secondary efficacy endpoint, 82 participants exhibited a sustained QFT-GIT conversion lasting at least 6 months following initial conversion (placebo=36; BCG=21; H4:IC31=25). These participants were evaluated to see if they would revert to negative as measured by the QFT-GIT test. In the BCG revaccination arm, the vaccine efficacy for preventing a sustained infection was 45.4% (p=0.013) and in the H4:IC31 arm the vaccine efficacy was 30.5% (p=0.08). The Health Site Two new vaccines have shown promise in preventing tuberculosis, the world s leading infectious disease killer The findings showed that re-vaccination with the Bacille Calmette-Guerin (BCG) vaccine and an experimental vaccine candidate named as H4:IC31, were effective in preventing sustained infections in high-risk adolescents. Agencies Updated: February 21, :57 am

13 Two new vaccines have shown promise in preventing tuberculosis, the world s leading infectious disease killer, results of new clinical trials show. The findings showed that revaccination with the Bacille Calmette-Guerin (BCG) vaccine and an experimental vaccine candidate named as H4:IC31, were effective in preventing sustained infections in high-risk adolescents. Introduced in 1921, BCG is the only licensed tuberculosis vaccine available globally, while H4:IC31 is an investigative subunit vaccine candidate being developed. We have demonstrated that (this) vaccination has the potential to reduce the rate of sustained tuberculosis infection in a high-transmission setting, said lead author Mark Hatherill, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town. While neither vaccine proved to be statistically significant in preventing an initial tuberculosis infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained tuberculosis infections. The results will provide significant scientific benefit to the field in understanding tuberculosis infection, and we look forward to testing the potential of such vaccines to prevent tuberculosis disease among uninfected adolescents, Hatherill said. According to the Global TB Report 2017, released by the World Health Organisation (WHO), India continues to have the highest number of tuberculosis (TB) cases in the world. In 2016, there were an estimated 10.4 million new tuberculosis cases worldwide. Seven countries accounted for 64 per cent of the total burden, with India having the maximum

14 number of tuberculosis patients, followed by Indonesia, China, Philippines, Pakistan, Nigeria and South Africa. In India, an estimated 27.9 lakh patients were suffering from tuberculosis in 2016 and up to 4.23 lakh patients were estimated to have died during the year, the report said. The study, presented at the Fifth Global Forum on TB Vaccines in New Delhi, involved 990 HIV-negative, healthy adolescents (12-17 years of age) who had been vaccinated as infants with BCG. All participants were randomised evenly into three study arms: placebo, H4:IC31, or BCG revaccination. The data showed that both vaccines appeared to be safe and produced an immune response in the adolescents studied. No vaccine-related serious adverse events were reported. As per WHO, about one-third of the world s population has what is called a latent tuberculosis infection, which means people have been infected by tuberculosis bacteria but are not (yet) ill with the disease and cannot transmit the disease. People infected with tuberculosis bacteria have a lifetime risk of falling ill with tuberculosis. People ill with tuberculosis can infect other people through close contact over the course of a year. Image source: IANS Bio Voice 5th Global forum on TB vaccines: Experts call for global funding on research Globally, there are 12 Tuberculosis vaccines in various stages of clinical trials, with many more candidates and concepts in earlier stages of development By BioVoice Correspondent - February 21, 2018

15 Express Healthcare 5th Global Forum on TB Vaccines kickstarts By EH News Bureau on February 21, 2018

16 Experts call to accelerate global funding on TB Vaccine research The 5th Global Forum on TB Vaccines commenced in New Delhi. The Forum is a scientific conference, which provides a platform for researchers, clinicians, product developers, policy makers, advocates, and other stakeholders, to review the state of the field, share the latest research and findings with the end goal of developing new TB vaccines. Experts agreed that there is an urgent need to develop an effective vaccine against both drug-sensitive and drug-resistant (Multi Drug Resistant and Totally Drug Resistant) TB. The target set forth in the WHO End TB Strategy to end the TB epidemic by 2035 cannot be achieved without new vaccines, as well as improved diagnostics and treatment. The inaugural ceremony was attended by Anupriya Patel, Minister of State for Health and Family Welfare; Dr Soumya Swaminathan, Deputy Director General (Programmes), World Health Organisation; Dr Ashutosh Sharma, Secretary, Department of Biotechnology; Preeti Sudan, Secretary, Ministry of Health and Family Welfare and other key dignitaries. A crucial pillar of the Government of India s TB elimination response, is the increased focus on R&D. We recently established the India TB Research Consortium to drive TB R&D efforts in the country. The consortium is working with public and private institutes, to guide the country s research efforts towards the development of point-ofcare diagnostics, shorter treatment regimens and an effective vaccine. We are confident

17 that this forum will accelerate efforts and we hope to see a new TB vaccine is the near future, said Anupriya Patel, Minister of State for Health and Family Welfare. The Forum is convened under the aegis of the Stop TB Partnership Working Group on New Vaccines. The organising partners for the forum include the Government of India s Department of Biotechnology (DBT), Translational Health Science and Technology Institute (THSTI), Indian Council of Medical Research (ICMR) and International organisers, Aeras and the TuBerculosis Vaccine Initiative (TBVI), both of which are non-profit organisations, facilitate the development of new, effective TB vaccines that are affordable and accessible. R&D is one of the pillars of the WHO s End TB Strategy and will play a pivotal role in achieving global elimination targets. However, a recent analysis indicates that globally, none of the key research areas i.e., drugs, vaccines, diagnostics and operational research achieved the recommended levels of funding outlined in the Global Plan to Stop TB Global funding for TB R&D in 2015 was $621 million (4,252 crores) its lowest level since While the Global Plan to End TB, , calls for annual investments of $250 million in TB vaccine research, vaccine R&D experienced the greatest decrease in funding from previous years, receiving only a little over $80 million in Dr Swaminathan said, The WHO End TB Strategy recognises the centrality of accelerating TB R&D efforts, especially for the development of an effective TB vaccine, to achieve our TB elimination efforts. Considering the country s expertise and experience in developing affordable and effective vaccines, the large number of young scientists, and the government s push for indigenous product development, it is appropriate that the Global Forum has chosen India as the venue for this conference, and we re glad to witness such large scale participation. In terms of vaccines, India has progressed from being one of the world s top vaccinemanufacturers to become an emerging player in the R&D of vaccines. The DBT is supporting TB initiatives in a major way by setting up Regional Prospective Observational Research for Tuberculosis (RePORT) India Consortium under the aegis of Indo-US Vaccine Action Programme, to enhance or build, combined biomedical and clinical research capacity in India. It is a matter of pride that India makes more than 60 per cent of the world s vaccines and are in the right direction to become a hub for vaccine R&D as well, said Dr Sharma. In the past few years, the Government of India has introduced several progressive policy changes which have transformed the way we diagnose and treat TB. However, in order to achieve our elimination targets, we recognise the importance of an effective vaccine and have therefore introduced supportive initiatives to drive TB vaccine R&D. We are glad that the Global Forum is being organised in India and we hope to have a fruitful and productive conference, said Sudan.

18 Daily pioneer TWO NEW VACCINES MAY BE EFFECTIVE IN PREVENTING TB: STUDY Wednesday, 21 February 2018 IANS New Delhi preventing-tb-study.html Two new vaccines have shown promise in preventing tuberculosis, the world's leading infectious disease killer, resultss of new clinical trials show. The findings showed that re- vaccination with the Bacille Calmette-Guerin (BCG) vaccine and an experimental vaccine candidate named as H4:IC31, were effective in preventing sustained infections in high-risk adolescents. Introduced in 1921, BCG is the only licensed tuberculosis vaccine available globally, while H4:IC31 is an investigative subunit vaccine candidate being developed. "We have demonstrated that (this) vaccination has the potential to reduce the rate of sustained tuberculosis infection in a high-transmission setting," said lead author Mark Hatherill, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town.

19 "While neither vaccine proved to be statistically significant in preventing an initial tuberculosis infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained tuberculosis infections. "The results will provide significant scientific benefit to the field in understanding tuberculosis infection, and we look forward to testing the potential of such vaccines to prevent tuberculosis disease among uninfected adolescents," Hatherill said. According to the Global TB Report 2017, released by the World Health Organisation (WHO), India continues to have the highest number of tuberculosis (TB) cases in the world. In 2016, there were an estimated 10.4 million new tuberculosis cases worldwide. Seven countries accounted for 64 per cent of the total burden, with India having the maximum number of tuberculosis patients, followed by Indonesia, China, Philippines, Pakistan, Nigeria and South Africa. In India, an estimated 27.9 lakh patients were suffering from tuberculosis in 2016 and up to 4.23 lakh patients were estimated to have died during the year, the report said. The study, presented at the Fifth Global Forum on TB Vaccines in New Delhi, involved 990 HIV-negative, healthy adolescents (12-17 years of age) who had been vaccinated as infants with BCG. All participants were randomised evenly into three study arms: placebo, H4:IC31, or BCG revaccination. The data showed that both vaccines appeared to be safe and produced an immune response in the adolescents studied.

20 No vaccine-related serious adverse events were reported. As per WHO, about one-third of the world's population has what is called a latent tuberculosis infection, which means people have been infected by tuberculosis bacteria but are not (yet) ill with the disease and cannot transmit the disease. People infected with tuberculosis bacteria have a lifetime risk of falling ill with tuberculosis. People ill with tuberculosis can infect other people through close contact over the course of a year. Drug Today vaccine-soon.html India hopeful of having new TB vaccine soon Rating 5.00 (1 Vote) POST 21 FEBRUARY 2018 DR SOUMYA SWAMINATHAN AT A TB CONFERENCE

21 BS RAWAT NEW DELHI: TB kills more than 4.2 lakh Indians every year. India's minister of state for health, Anupriya Patel, has expressed the hope that the country will have a formidable weapon against tuberculosis (TB) in the form of a new vaccine very soon. Inaugurating the 5th Global Forum on TB Vaccines in New Delhi, Ms Patel said, We are confident that this forum will accelerate efforts and we hope to see a new TB vaccine in the near future. The minister stated, A crucial pillar of the India s TB elimination response is the increased focus on R&D. Ms Patel maintained, We recently established the India TB Research Consortium to drive TB R&D efforts in the country. The consortium is working with public and private institutes, to guide the country s research efforts towards the development of point-of- Organization Dr Soumya Swaminathan said that globally, governments need to invest care diagnostics, shorter r treatment regimens and an effective vaccine. Participating in the conference, deputy director general of the World Health more in TB research and development to meet the global targets. Hendrick Bekedam, WHO representative to India, stated that TB vaccine was a global public health good, which meant governments need to invest if they want to own it later. Over 4.2 lakh Indians die of TB every year. Out of the 10 million cases globally, India shoulders the maximum burden with 2.8 million cases. Health Ministry data reveals that only 63% of the patients infected with the airborne disease are currently under treatment. Further, 1,47,000 patients are resistant to first and second line TB medicines. effective-in-preventing-tb-study/ Two new vaccines may be effective in preventing TB: Study THE HANS INDIA Feb 22,2018, 12:16 AM IST

22 Two new vaccines may be effective in preventing TB: Study Two new vaccines have shown promise in preventing tuberculosis, the world's leading infectious disease killer, results of new clinical trials show. The findings showed that re-vaccination with the Bacille Calmette-Guerin (BCG) vaccine and an experimental vaccine candidate named as H4:IC31, were effective in preventing sustained infections in high-risk adolescents. Introduced in 1921, BCG is the only licensed tuberculosis vaccine available globally, while H4:IC31 is an investigative subunit vaccine candidate being developed. "We have demonstrated that (this) vaccination has the potential to reduce the rate of sustained tuberculosis infection in a high-transmission setting," said lead author Mark Hatherill, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town. "While neither vaccine proved to be statistically significant in preventing an initial tuberculosis infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained tuberculosis infections.

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