The Tuberculosis Research Centre (TRC) in Chennai has started the process of phase-1 trial of Prime-Boost AIDS Vaccine and has enrolled the first volunteer on April 1. The volunteer got the first of the four doses, said Dr V D Ramanathan, Research Scientist in the TRC. He said a simultaneous trial will also be held at the National AIDS Research Institute, Pune.
Dr Ramanathan, senior deputy director of the Institute, said healthy individuals between the age of 18 and 50 who are at low risk for getting HIV infection have been selected as volunteers. No AIDS patient has been selected for the phase-1 trial.
Speaking to Pharmabiz, he said that since the phase-1 trial continues for around two years time to get a clear-cut result, the time of the phase-2 trial cannot be determined now. The phase-2 depends up on the result of the first one, he added. National AIDS Research Institute (NARI), Pune and TRC Chennai are the two sites where the study is being conducted at present. The US-based International AIDS Vaccine Initiative and YRG Care Centre, Chennai are associating with TRC in the research and trials.
For the phase-1 trial strategy, ADVAX, a DNA based vaccine is used as the Prime and MVA-based vaccine (a vector that contains six HIV genes) is taken for the boost.
Dr Ramanathan clarified that MVA was considered to accept as boost, because of the fact that it would be possible to boost the level of immune responses produced by ADVAX.
To complete the trial, thirty-two volunteers will be recruited with 16 each at NARI and the TRC. At each centre, the 16 volunteers will be divided into two wings of eight each. One will get only MVA while the other will get ADVAX and MVA (prime-boost). Two volunteers in each will get a placebo, Dr Ramanathan explained.
He said, earlier the TRC had successfully conducted phase-1 trials of an MVA-based AIDS vaccine candidate (TBC-M4), which indicated that the vaccine candidate had acceptable levels of safety and was well tolerated. The trial was conducted under the aegis of an MoU between the Government of India-through ICMR, NACO and IAVI. But the decision to conduct a phase-1 trial using MVA was dropped and a strategy for using prime-boost was considered.
TRC has been developed as a global centre of excellence for clinical evaluation of AIDS vaccines in India. The Vaccine Trial Centre (VTC), established at TRC, includes a clinical facility, a data management unit and a state-of-the-art HIV immunology, virology and routine medical laboratory.