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24-02-2016, 11:55 AM
New and improved TB vaccine undergoes trial
Hope are high for a new and improved Tuberculosis vaccine, with the Pune-based Serum Institute of India working towards a promising vaccine — originally developed in Germany — and introducing it in a clinical setting.
Serum, one of the world’s leading vaccine manufacturers, has signed a contract with Hanover-based Vakzine Projekt Management GmbH and secured the license to manufacture it. The new vaccine to prevent TB - will be tested in over 2,000 adults in an ambitious trial to be undertaken by Indian Council of Medical Research (ICMR), National Institutes of Health and others. Currently another ambitious phase II trial is also underway at South Africa that includes 416 newborn from both HIV positive and HIV negative mothers to define the safety of the This clinical study primarily aims at defining safety of the new TB vaccine (VPM1002) in HIV-exposed newborn.
Currently, VPM1002 is under negotiation with regulatory agencies in India, for a multicentric phase III trial in adults. The goal of this study is to determine the capacity of the vaccine to protect against relapse when given after successfully completed drug treatment of TB patients.
Dr Soumya Swaminathan, Director General of ICMR said that the adult group will initially be tested as part of the clinical trials. This group will essentially be those who have been detected with TB and completed the six month treatment. “The trials will enroll those who have been cured of TB so as to prevent a relapse,” said Dr Swaminathan.
BCG remains the only licensed vaccine against TB that is inexpensive, and requires only one contact with health services. Now, a group, headed by Dr Stefan H E Kaufmann, director of Max Planck Institute for Infection Biology, Berlin, has developed the recombinant vaccine. The institute holds the patent and has licensed the vaccine to VPM , Germany, that in turn licensed it to Serum Institute in Pune. Serum will manufacture the vaccine, which now is being tested on humans, Umesh Shaligram, Director, R& D, Serum Institute told The Indian Express.
Despite many advances in TB control, the pandemic continues relentlessly. In 2012, TB was the second-leading cause of death from infectious disease worldwide, after HIV, with 8.6 million new cases. HIV-TB coinfection is especially lethal, contributing to 3,20,000 deaths of the 1.3 million TB-related deaths in 2012 .
Hope are high for a new and improved Tuberculosis vaccine, with the Pune-based Serum Institute of India working towards a promising vaccine — originally developed in Germany — and introducing it in a clinical setting.
Serum, one of the world’s leading vaccine manufacturers, has signed a contract with Hanover-based Vakzine Projekt Management GmbH and secured the license to manufacture it. The new vaccine to prevent TB - will be tested in over 2,000 adults in an ambitious trial to be undertaken by Indian Council of Medical Research (ICMR), National Institutes of Health and others. Currently another ambitious phase II trial is also underway at South Africa that includes 416 newborn from both HIV positive and HIV negative mothers to define the safety of the This clinical study primarily aims at defining safety of the new TB vaccine (VPM1002) in HIV-exposed newborn.
Currently, VPM1002 is under negotiation with regulatory agencies in India, for a multicentric phase III trial in adults. The goal of this study is to determine the capacity of the vaccine to protect against relapse when given after successfully completed drug treatment of TB patients.
Dr Soumya Swaminathan, Director General of ICMR said that the adult group will initially be tested as part of the clinical trials. This group will essentially be those who have been detected with TB and completed the six month treatment. “The trials will enroll those who have been cured of TB so as to prevent a relapse,” said Dr Swaminathan.
BCG remains the only licensed vaccine against TB that is inexpensive, and requires only one contact with health services. Now, a group, headed by Dr Stefan H E Kaufmann, director of Max Planck Institute for Infection Biology, Berlin, has developed the recombinant vaccine. The institute holds the patent and has licensed the vaccine to VPM , Germany, that in turn licensed it to Serum Institute in Pune. Serum will manufacture the vaccine, which now is being tested on humans, Umesh Shaligram, Director, R& D, Serum Institute told The Indian Express.
Despite many advances in TB control, the pandemic continues relentlessly. In 2012, TB was the second-leading cause of death from infectious disease worldwide, after HIV, with 8.6 million new cases. HIV-TB coinfection is especially lethal, contributing to 3,20,000 deaths of the 1.3 million TB-related deaths in 2012 .
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