The preliminary results of the much anticipated Phase II TB vaccine trial conducted in 240 individuals who are HIV positive and those not infected with the virus will become available in December this year.
The Phase II trial (Tuberculosis-014) began in November 2011 and is being carried out at the YRG Care Medical Centre, Chennai.
All the 240 subjects do not suffer from active TB. Tuberculosis was ruled out by sputum examination, chest X-ray, and clinical examination.
The 240 individuals are split into three equal groups of 80 subjects each. The first group comprises those who are infected with HIV and are taking antiretroviral therapy (ART) as their CD4 count is less than 350. The second group comprises HIV positive people who are not taking antiretroviral therapy as their CD4 count is more than 350. The last group of 80 people comprises those who are not infected with HIV.
In each of the three groups of 80 subjects, 40 would have got a vaccine and the remaining half would have got a placebo. The randomised, double-blind, placebo-control study will last for three years. The prime objective of this trial is to test the safety, immune responses (immunogenicity) and efficacy of the candidate TB vaccine.
“Till now the vaccine is safe and tolerable. Other findings will be known after the December 2012 interim analysis,” said Dr. N. Kumarasamy, Principal Investigator of the trial and also the Chief Medical Officer at YRG Care Medical Centre, Chennai.