The phase I trial of the Modified Vaccina Ankaara (MVA) or TBC-M4 AIDS vaccine trial on human beings, which is going to commence in the last quarter of this year, will focus on assessing the safety and immunogenic capacity of the vaccine, according to DrV.D.Ramanathan, principal investigator of the trial and deputy director and Head of Clinical pathology of Tuberculosis Research Centre, Chennai. The trial will be conducted by TRC, a research institute of the Indian Council for Medical Research (ICMR).
Right now, with whole of the 18 members working in Tuberculosis Research Centre, by using the immunology laboratory in the centre, 32 volunteers are going to be participating in the trial. More people may be enlisted for the community work on AIDS vaccine trial. The results of this trial will orient further clinical studies to be conducted, Dr Ramanathan revealed to Pharmabiz.
The trial of vaccine on human beings may take approximately two years, according to Dr Ramanathan. This is the second AIDS vaccine to be tried on humans in India. The Genetic Engineering Approval Committee (GEAC) of the Union Environment and forest ministry has given approval for the trial on June 8.
The vaccine manufactured by an American company, Theroin Biologics Corporation, is ICMR’s first vaccine to be tried on human beings. ICMR began human trial of the Adeno Associated Vector Borne Vaccine (AAV) in the beginning of this year.
The vaccine has been approved for testing by the Health Ministry and the screening committee of the Drugs Controller General of India.