The Hindu : National : Genetic committee approves clinical trial of AIDS vaccine

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Thursday, Jun 09, 2005

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National

Genetic committee approves clinical trial of AIDS vaccine

Staff Correspondent

Second vaccine to be tried on humans in India

NEW DELHI: The Genetic Engineering Approval Committee (GEAC) of the Union Environment and Forests Ministry on Wednesday approved phase-I of the clinical trial of a new preventive recombinant AIDS vaccine, Modified Vaccina Ankara (MVA) or TBC-M4. This is the second AIDS vaccine to be tried on humans in India.

Manufactured by an American company, Therion Biologics Corporation, the trials would be conducted by the Chennai-based Tuberculosis Research Centre, an institute of the Indian Council for Medical Research (ICMR).

TBC-M4 was supposed to be the ICMR's first AIDS vaccine to be tried on human beings but its testing was delayed for technical reasons. The ICMR began human trial of the AAV vaccine in February this year.

The actual trial of TBC-M4 is likely to start in the fourth quarter of this year and the Tuberculosis Research Centre has started training its staff in Chennai.

The vaccine has been approved for testing by the Health Ministry and the screening committee of the Drugs Controller of India.

The Committee also gave the green signal for import of Denimax 16000 L and Denimax XCL by Luminis Biotech Pvt Ltd, Mumbai, from the Denmark-based Novozymes. Permission has been given to import and market 16 IU LG Eutropin (human growth hormone) by the Delhi-based L.G. Chemical. Phase-III clinical trials of r insulin Lispro (cr-DNA origin) by Wockhardt, Mumbai, have also been allowed.

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