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Clinical trials of TB vaccine MTBVAC begin in India

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Hyderabad, March 24 (IANS) The clinical trials of MTBVAC, the Spanish tuberculosis vaccine, began among adults in India.

The trials of the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human are being carried out by Bharat Biotech in close collaboration with Biofabri, a Spanish biopharmaceutical company.

Trials to evaluate the safety and immunogenicity of MTBVAC have started with a pivotal safety, immunogenicity and efficacy trial planned to start in 2025, the companies said in a joint statement on Sunday

“After more than three decades of research, it is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate,” said Esteban Rodriguez, CEO of Biofabri.

The only vaccine in use today, BCG (Bacillus Calmette and Guérin), is an attenuated variant of the bovine TB pathogen. It is more than 100 years old and has a very limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease. The companies hope that the new vaccine will be a milestone in global vaccinology and called it an example of public-private, national and international collaboration.

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“Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today. We are honoured to partner with BioFabri, Dr. Esteban Rodriguez and Dr. Carlos Martin in this noble effort to reinvent TB vaccines,” said Krishna Ella, Executive Chairman Bharat Biotech.

After the completion of a Phase2 dose finding trial the MTBVAC vaccine, a double-blind, controlled Phase3 clinical trial in newborns started in 2023, comparing the vaccine with the current BCG vaccine. 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated.

The aim is to assess the immunogenicity and efficacy of MTBVAC which is administered intradermally to infants on the first day of life.

Health restrictions imposed during the COVID-19 pandemic led to an increase in infections and a decrease in diagnosis and treatment. As a result, annual TB deaths have risen to over 1.6 million.

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This Phase3 neonatal project, partially funded by the European Union through its EDCTP (European & Development Countries Clinical Trial Partnership) programme, is being coordinated by Biofabri, as part of a consortium.

After completing a dose escalation trial in HIV uninfected adults, a Phase2 study in HIV infected adults has started in 2024 to determine whether MTBVAC is safe in this population. This ongoing trial at 16 sites in South Africa – involving the vaccination of 276 adults – is evaluating safety and immunogenicity in HIV-negative and HIV-positive adults and adolescents vaccinated with MTBVAC.

–IANS

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Cut down smoking to avoid cognitive ageing: Study

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New Delhi, July 6 (IANS) Want to maintain sharp memory skills and cognitive function as you age? Cutting down on smoking suggests a large study that found it to be a key lifestyle factor linked to cognitive decline.

The study, published in Nature Communications, is based on a 10-year survey of 32,000 adults aged 50 or over from 14 countries in Europe.

The team led by researchers from the University College London, UK showed that cognitive decline was faster for lifestyles that included smoking. People who smoked had cognitive scores that declined up to 85 per cent more over 10 years than those who did not.

Lead author Mikaela Bloomberg (UCL Behavioural Science & Health) said the study “is observational; it cannot definitively establish cause and effect, but it suggests smoking might be a particularly important factor influencing the rate of cognitive ageing”.

As per previous studies, people who engaged in more healthy behaviours like regular exercise, and moderate alcohol intake have slower cognitive decline. However, it did not specify whether all behaviours contributed equally to cognitive decline.

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However, the new study showed that among the healthy behaviours, “not smoking may be the most important in terms of maintaining cognitive function”.

Among those unable to stop smoking, the study suggests engaging in other healthy behaviours such as regular exercise, moderate alcohol consumption, and remaining socially active “to offset adverse cognitive effects”, Mikaela said.

–IANS

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Surging dengue cases in K'taka: BJP urges Cong govt to declare medical emergency

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Bengaluru, July 6 (IANS) The BJP in Karnataka has demanded that the Congress government declare a medical emergency over the rising dengue cases in the state.

Addressing a joint press conference at the BJP headquarters in Bengaluru, BJP MP C.N. Manjunath demanded that along with declaring a medical emergency, the state government should also form a task force and take the opinion of experts in handling the situation.

“Dengue is detected more among children and it is increasing every day. Six to seven deaths have been reported so far and more than 7,000 active dengue cases are reported in the state. Every day 600 to 700 dengue cases are reported in the state.”

“More cases are reported in Bengaluru, Chikkamagaluru, Mysuru and Hassan. A doctor has succumbed to dengue fever,” Manjunath said.

“Once complications start in dengue, death is 99 per cent as there is no treatment. Controlling dengue is nothing but controlling mosquitoes. The medicines would be administered for fever and blood pressure,” he added.

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“Along with dengue, mosquitoes will also infect people with Zika virus and Chikungunya. Dengue should be declared as an endemic as it has affected people all over the state. The war-footing approach, like how things moved during Covid-19, is needed to tackle the spread of dengue, hence there is a need to declare a medical emergency,” the BJP MP said.

Manjunath also added that the growth of mosquitoes is not coming under control as the construction of flyovers, underpasses and bridges have not been completed on time.

“The land is dug and water is filled and it is becoming a breeding ground for Aedes aegypti mosquitoes known as primary transmitters of dengue fever.”

State BJP Spokesperson C.N. Ashwath Narayan said: “Dengue is spread in all districts. It is a seasonal disease and the Congress government has failed to take precautions. Health Minister Dinesh Gundu Rao is busy touring the state and engaged with party-related activities.”

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The Union government had issued a circular on precautions to be taken by the states after dengue cases were reported from Maharashtra, he added.

“Minister Gundu Rao is not at all focused on the rising number of cases of dengue fever in the state. The private hospitals and laboratories are charging exorbitant rates for blood tests from Rs 1,000 to 1,500, violating all guidelines by the government in this regard,” he said while criticising the Karnataka government.

–IANS

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'Will affect lakhs of honest students': Centre opposes cancellation of NEET-UG exam in SC

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New Delhi, July 5 (IANS) The Centre, in a preliminary affidavit filed before the Supreme Court on Friday opposed the batch of pleas seeking cancellation of the NEET-UG examination, for admission in undergraduate medical programmes, saying it would affect “lakhs of honest candidates” who appeared in it on May 5.

The Union Ministry of Education said that scrapping the entire exam would seriously jeopardise the interests of the lakhs of honest candidates who attempted the question paper held on May 5 this year.

“In the absence of any proof of any large-scale breach of confidentiality in a pan-India examination, it would not be rational to scrap the entire examination and the results already declared. It is submitted that in any examination, there are competing rights that have been created whereby the interests of a large number of students who have taken the examination without adopting any alleged unfair means must not also be jeopardised,” the affidavit said.

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As regards the alleged instances of irregularities, including cheating, impersonation, and malpractices, the Central Bureau of Investigation (CBI) is undertaking an investigation and has taken over the cases registered in different states, it added.

The Centre said that it is committed to conducting all competitive examinations in a fair and transparent manner and if at the behest of some criminal elements, the confidentiality of competitive examinations has been breached, they must be dealt with sternly and with the full force of law to ensure that they are punished.

“The Government is committed to ensure the sanctity of examinations and protect the interest of students. To ensure transparency, fairness, and credibility in public examination, Parliament has enacted the Public Examination (Prevention of Unfair Means) Act, 2024 on 12.02.2024. The Act was brought into effect on 21.06.2024 and provides for stringent punishment for offences related to unfair means in public examinations. Public Examination (Prevention of Unfair Means) Rules, 2024 under the Act have also been notified on 23.06.2024,” it said.

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Recently, the top court had expressed reservations over the filing of a writ petition by a coaching institute alleging irregularities in the conduct of the NEET-UG exam.

“What fundamental rights of yours are violated to enable you to maintain a writ petition filed under Article 32 of the Constitution?” a vacation bench had asked the senior counsel representing Xylem Learning, a coaching institution providing assistance to NEET students.

Meanwhile, President Droupadi Murmu, in her address to a joint sitting of Parliament, asserted that the government was committed to a fair investigation and ensuring strict punishment to the guilty in the instances of paper leaks.

“Even earlier, we have witnessed many instances of paper leaks in different states. It is important that we rise above party politics and undertake concrete measures nationwide. Parliament has also enacted a strict law against unfair means in examinations,” she added.

The Supreme Court is slated to hear on July 8 the batch of petitions pertaining to the NEET-UG exam, including its cancellation.

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–IANS

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Study shows how cancer evades chemotherapy, finds mechanism to reverse

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New Delhi, July 5 (IANS) An international team of researchers from the UK and China has shown how cancer builds up resistance to chemotherapy — one of the biggest challenges in the treatment of the deadly disease.

Using a mice study, the early-stage research, led by The Institute of Cancer Research (ICR), London, and Sun Yat-sen University, China showed that Stiripentol — a drug currently used to treat epilepsy — can help reverse cancer’s resistance to chemotherapy, which will help shrink tumours and prolong survival.

In the study, the team zeroed in on lactate — the product that builds up as cancer cells convert nutrients to energy — which was found to be most abundant in chemotherapy-resistant cancer tissues.

For the study, published in the journal Nature, the researchers examined tissue from 24 patients with stomach cancer, where 15 of the cancers were resistant to chemotherapy and the tumours had continued to grow.

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Stiripentol and chemotherapy reduced the size of tumours — for four weeks after treatment — in mice with stomach cancer. These also survived for longer — for more than 70 days.

In comparison, tumours in mice treated with chemotherapy alone shrunk for one week and started to grow again. With only chemotherapy, no mice survived for longer than 40 days after treatment.

Further, lactate was also found responsible for altering the structure of a key protein involved in DNA repair, called NBS1, and affecting its efficiency.

The researchers believe that lactate may be behind chemotherapy resistance in other cancers such as “pancreatic, lung and ovarian cancers”.

“This extremely promising research has uncovered a likely mechanism for how cancer evades chemotherapy,” said Professor Axel Behrens, Professor of Stem Cell Biology at The Institute of Cancer Research.

“In our early-stage study, we’ve seen that you can prevent the build-up of lactate and make a tumour that was resistant to chemotherapy sensitive again — the treatment continues to work,” Axel added.

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–IANS

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Ultra-processed food ads misleading; fuelling obesity & diabetes in India: Report

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New Delhi, July 5 (IANS) Advertisements of unhealthy food products with high salt (HFSS) food products, or ultra-processed food (UPF) are misleading and are “seductive, luring, manipulative or deceptive” people to buy and in turn increasing the incidences of obesity and diabetes, according to a new report on Friday.

The report ’50 Shades of Food Advertising’, by the Nutrition Advocacy in Public Interest (NAPi), is based on an observational study of the appeal in 50 advertisements of food products that have appeared in popular English and Hindi newspapers available in Delhi and also took note of some of the ads that appeared in TV commercials during cricket games or few on social media.

It calls upon the government to amend existing regulations to end these misleading ads.

The report comes as India is facing persistent undernutrition among children under five, and a rising trend of obesity and diabetes among grown-ups.

The recent ICMR-National Institute of Nutrition (NIN)’s dietary guidelines for Indians reveals that more than 10 per cent of 5-19- year-olds are pre-diabetic. This is when the government has set a target to halt the rise of obesity and diabetes among Indians by 2025.

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The report provides evidence that food and drink products under the category of unhealthy/HFSS or UPFs “are being advertised by using different appeals such as evoking emotional feelings, manipulating the use of experts, appropriating benefits of real fruits, using celebrities to add value to the brand, projecting as healthy, etc”.

It noted that these advertisements mislead on many counts; and also provide information on the gaps in the existing legislations, such as the FSS Act of 2006, the Cable TV Networks Regulation Act, 1994 and Rules, the Consumer Protection Act of 2019, and the Norms of Journalistic Conduct 2022.

Arun Gupta, a pediatrician and NAPi convenor, called on the government to implement measures for “each advertisement to disclose in bold letters the amount of nutrient of concern per 100 gram/ml”.

It would be in the best interest of the people’s health that a public health ‘Bill’ is proposed in the Parliament to halt obesity. If we fail to halt the rising trend, it will only increase the disease and economic burden, year by year on the individual family and the health system as a whole,” he added.

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NAPi also recommends stopping any food advertisements if the food product is HFSS and UPF.

The report also provides an objective method of identifying what is misleading food advertising to help authorities like the FSSAI make a quick decision to stop it, said Nupur Bidla, a member of NAPi and a social scientist, adding that the delay in banning the ads helps “companies to enjoy the ‘freedom’ to advertise and make money while public health may suffer”.

–IANS

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