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Economic Times
3 days ago
- Health
- Economic Times
Phase-3 clinical trial enrolment for India's first dengue vaccine to be completed by October: ICMR
Synopsis India's DengiAll vaccine trial is nearing completion. ICMR scientists anticipate enrolling 10,500 participants by October across 20 Indian centers. The phase III trial assesses the Panacea Biotec's one-shot dengue vaccine. Initial trials showed no safety concerns. Participants will be monitored for two years to evaluate efficacy. This is a crucial step as India currently lacks a licensed dengue vaccine. Agencies Representational image Enrolment of about 10,500 participants in the phase III clinical trial of the indigenous one-shot Panacea Biotec developed dengue vaccine, DengiAll, is likely to be completed by October across 20 centres in India, according to ICMR far, 8,000 participants in various centres at Pune, Chennai, Kolkata, Delhi and Bhubaneswar among others have received either the vaccine or a placebo as part of the trial sponsored by the Indian Council of Medical Research (ICMR) and Panacea Biotec. The trial is co-led by ICMR-National Institute of Translational Virology and AIDS research in Pune, National Institute of Epidemiology (NIE), Chennai and National Institute of Virology, there is no antiviral treatment or licensed vaccine against dengue in results of the Phase-1/2 trial has shown no safety concerns for the one-shot vaccine, NIE Director Dr Manoj Murhekar said. "The participants enrolled in the Phase- III trial will be followed up for two-years. This trial will evaluate the efficacy of this tetravalent dengue vaccine," Dr Murhekar multi-centre, double-blind, randomised, placebo-controlled phase-III trial was launched in August last year to evaluate the jab's efficacy, safety and, long-term immunogenicity. The first participant in this trial was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak last year. The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections, Dr Murhekar said. In India, all four serotypes of dengue virus are known to circulate or co-circulate in many regions. The Union Health Ministry in a statement earlier had said that the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in clinical trials in Brazil. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Dengue is a major public health concern in India, ranking among the top 30 countries with the highest incidence of the disease. The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organisation (WHO).In India, approximately 75-80 per cent of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes. Among the 20-25 per cent of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality. In adults, the disease can escalate into severe conditions like dengue hemorrhagic fever and dengue shock syndrome. According to the government data, around 12,043 dengue cases were reported till March this year. In 2024, 2.3 lakh cases and 297 deaths had been recorded.
Time of India
3 days ago
- Health
- Time of India
Phase-3 clinical trial enrolment for India's first dengue vaccine to be completed by October: ICMR
Enrolment of about 10,500 participants in the phase III clinical trial of the indigenous one-shot Panacea Biotec developed dengue vaccine, DengiAll, is likely to be completed by October across 20 centres in India, according to ICMR scientists. So far, 8,000 participants in various centres at Pune, Chennai, Kolkata, Delhi and Bhubaneswar among others have received either the vaccine or a placebo as part of the trial sponsored by the Indian Council of Medical Research (ICMR) and Panacea Biotec. The trial is co-led by ICMR-National Institute of Translational Virology and AIDS research in Pune, National Institute of Epidemiology (NIE), Chennai and National Institute of Virology, Pune. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Currently, there is no antiviral treatment or licensed vaccine against dengue in India. The results of the Phase-1/2 trial has shown no safety concerns for the one-shot vaccine, NIE Director Dr Manoj Murhekar said. Live Events "The participants enrolled in the Phase- III trial will be followed up for two-years. This trial will evaluate the efficacy of this tetravalent dengue vaccine," Dr Murhekar said. The multi-centre, double-blind, randomised, placebo-controlled phase-III trial was launched in August last year to evaluate the jab's efficacy, safety and, long-term immunogenicity. The first participant in this trial was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak last year. The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections, Dr Murhekar said. In India, all four serotypes of dengue virus are known to circulate or co-circulate in many regions. The Union Health Ministry in a statement earlier had said that the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in clinical trials in Brazil. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Dengue is a major public health concern in India, ranking among the top 30 countries with the highest incidence of the disease. The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organisation (WHO). In India, approximately 75-80 per cent of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes. Among the 20-25 per cent of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality. In adults, the disease can escalate into severe conditions like dengue hemorrhagic fever and dengue shock syndrome. According to the government data, around 12,043 dengue cases were reported till March this year. In 2024, 2.3 lakh cases and 297 deaths had been recorded.
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Business Standard
3 days ago
- Health
- Business Standard
India's dengue vaccine Phase-3 trial enrolment to be completed by Oct: ICMR
Enrolment of about 10,500 participants in the phase III clinical trial of the indigenous one-shot Panacea Biotec developed dengue vaccine, DengiAll, is likely to be completed by October across 20 centres in India, according to ICMR scientists. So far, 8,000 participants in various centres at Pune, Chennai, Kolkata, Delhi and Bhubaneswar among others have received either the vaccine or a placebo as part of the trial sponsored by the Indian Council of Medical Research (ICMR) and Panacea Biotec. The trial is co-led by ICMR-National Institute of Translational Virology and AIDS research in Pune, National Institute of Epidemiology (NIE), Chennai and National Institute of Virology, Pune. Currently, there is no antiviral treatment or licensed vaccine against dengue in India. The results of the Phase-1/2 trial has shown no safety concerns for the one-shot vaccine, NIE Director Dr Manoj Murhekar said. "The participants enrolled in the Phase- III trial will be followed up for two-years. This trial will evaluate the efficacy of this tetravalent dengue vaccine," Dr Murhekar said. The multi-centre, double-blind, randomised, placebo-controlled phase-III trial was launched in August last year to evaluate the jab's efficacy, safety and, long-term immunogenicity. The first participant in this trial was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak last year. The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections, Dr Murhekar said. In India, all four serotypes of dengue virus are known to circulate or co-circulate in many regions. The Union Health Ministry in a statement earlier had said that the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in clinical trials in Brazil. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Dengue is a major public health concern in India, ranking among the top 30 countries with the highest incidence of the disease. The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organisation (WHO). In India, approximately 75-80 per cent of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes. Among the 20-25 per cent of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality. In adults, the disease can escalate into severe conditions like dengue hemorrhagic fever and dengue shock syndrome. According to the government data, around 12,043 dengue cases were reported till March this year. In 2024, 2.3 lakh cases and 297 deaths had been recorded.
The Hindu
4 days ago
- Health
- The Hindu
Enrolment in third phase clinical trials for India's first dengue vaccine nearly complete, says ICMR
Following an announcement by the Indian Council of Medical Research (ICMR) and Panacea Biotec Limited to initiate third phase trials, about 8,000 of the targeted 10,000 participants have enrolled in the third phase of clinical trials for a dengue vaccine in India, Manoj Murhekar, Director, National Institute of Epidemiology, ICMR, Chennai, told The Hindu. The trial will be rolled out at 20 centres across the country, Dr. Murhekar said. 'In India, all four serotypes of the dengue virus are known to circulate or co-circulate in many regions, so it's vital to ensure that we have an effective vaccine that achieves good efficacy for all four serotypes,'' he added. The trial is primarily funded by ICMR, with partial support from Panacea Biotec. Participants will be followed up for two years under projects spread across various centres, including Chennai, Pune, Hyderabad, and Delhi. There is currently no antiviral treatment or licensed vaccine for dengue in India. 'This landmark trial will evaluate the efficacy of India's indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec. The first participant in this trial was vaccinated last year at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak,'' a release issued by the Union Health Ministry said. The tetravalent dengue vaccine strain (TV003/TV005) originally developed by the National Institutes of Health, the U.S., has shown promising results in preclinical and clinical trials worldwide. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of developing a vaccine. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. The first and second phases of the clinical trials of Indian vaccine formulations were completed in 2018-19, yielding promising results. Dengue is a major public health concern in India, which ranks among the top 30 countries with the highest incidence of the disease. The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organization (WHO). In India, approximately 75-80% of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes. Among the 20-25% of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality. In adults, the disease can escalate into severe conditions, including the dengue hemorrhagic fever and dengue shock syndrome. The dengue virus has four serotypes, 1-4, with low cross-protection against each other, which means individuals can experience repeated infections.
Indian Express
4 days ago
- Health
- Indian Express
How a novel initiative helped Tamil Nadu bring down TB deaths in the state
Tamil Nadu has witnessed a dip in the number of tuberculosis (TB) deaths in the state after the rollout of the Tamil Nadu Kasanoi Erappila Thittam (TN-KET), or TB death free initiative, in 2022. Due to the initiative, three districts — Dharmapuri, Karur, and Villupuram — witnessed a reduction in the number of TB deaths between 2022 and 2023, according to a paper published in the Indian Journal of Community Medicine. The TB death rate in Dharmapuri went down from 12.5% to 7.8%, in Karur from 7.1% to 5.3%, and in Villupuram from 6.1% to 5.2%. Scientists at the National Institute of Epidemiology told The Indian Express that within the six months of the TN-KET program, Tamil Nadu saw a dip in the number of early TB deaths by 20% across the state. Two-thirds of the districts in the state documented a 20% to 30% reduction in total deaths in 2024, according to scientists. Experts say, the program has been successful for two reasons. One, it uses a quick, easy-to-use tool, which helps a doctor determine whether a patient is severely ill and needs to be hospitalised soon after being diagnosed with TB. The tool does not require any laboratory-based investigations. Two, the initiative follows a differentiated care model which offers a patient-centred approach instead of a one-size-fits-all treatment. Tamil Nadu health workers use a paper-based triage tool which prioritises patient care based on the severity of the illness. To determine the severity, health workers record five key parameters for all TB patients in the state. If a patient has a BMI of less than 14 kg/sq m, or suffers from respiratory issues, or performs poorly on any of the other metrics, they are tagged as 'severely ill'. Such a patient is immediately referred for comprehensive assessment and inpatient treatment (care provided in a hospital or in some sort of medical facility). Note that this paper-based triage tool is simpler than other tools where health workers have to record 16 parameters of a patient, and send them for laboratory-based investigation. This makes the process of diagnosis at least a week long. Using the TN-KET program's triage tool, a diagnosis can be made within a day. Since the implementation of the initiative, 98% of the patients diagnosed with TB in Tamil Nadu get examined using the triage tool, and 98% of those confirmed to be severely ill are admitted to hospitals within seven days of diagnosis, according to scientists. The Tamil Nadu government has also launched a portal called Severe TB Web Application, where once the recorded parameters are entered, one can assess 'the probability of a patient dying', Manoj Murhekar, head of the National Institute of Epidemiology, told The Indian Express. 'This will help guide the health workers to take immediate action and prevent TB deaths,' he said. The TN-KET is one of India's first initiatives to implement the differentiated care guidelines issued by the National Tuberculosis Elimination Programme (NTEP) in 2021. By following a patient-centred model, it provides treatment based on a patient's medical history and medical parameters such as age, weight, and specific disease conditions. It also considers the severity of the disease in all patients diagnosed with TB, and provides comprehensive care to the worst affected. Combined with a quick examination of TB patients through the triage tool, this model has been highly effective in preventing early deaths of the worst affected patients. Usually, 50% of those who die due to TB, lose their lives within the first two months after being diagnosed. 'Immediate inpatient care can reduce the probability of early death in severely ill patients by 1% to 4%. Usually, the probability of death in such patients is between 10% and 50%,' said Hemant Shewade, senior scientist at the National Institute of Epidemiology, who has studied the implementation of the TN-KET. Currently, India bears the highest burden of TB across the world. With an estimated 28 lakh cases, the country accounted for 26% of the global TB burden in 2023, according to the Global TB report, which was released last year. With 3.15 lakh deaths due to TB in 2023, India accounted for 29% of the global burden, the report revealed. The success of the TN-KET program has demonstrated that a differentiated care model combined with the use of a simple triage tool could save the lives of TB patients. This initiative can now be emulated by other states, helping reduce the number of TB deaths across the country. Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government's management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country's space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University's Dart Centre. Dutt has a Bachelor's Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
