Indian HIV/AIDS vaccine to go on 2nd phase of human testing by 2011

A potential vaccine candidate against HIV/AIDS developed by Indian researchers is showing early promise in human volunteers.

The HIV/AIDS vaccine is currently being tested jointly by Tuberculosis Research Centre (TRC), Chennai and National AIDS Research Institute (NARI), Pune in 32 healthy people, reports said.

The first round of human studies using the Indian HIV/AIDS vaccine, which will be completed this year, has been found safe in patients. No adverse reactions have been reported so far. Related: Glaxo-Pfizer JV offers free access to new HIV/AIDS medicines to low-cost generic makers in poorer nations

TRC and NARI are expected to start the second round of human studies using the India-made HIV/AIDS vaccine in early 2011.

The Indian HIV/AIDS vaccine failed to meet the required level of immunity boosting capacity in clinical trials conducted in 2008.

Now that the Indian HIV/AIDS vaccine has been enhanced with a booster, the researchers are awaiting the data from 32 healthy volunteers.

If the data shows that the new version of the vaccine could boost the immunity to the desired level,Indian researchers will take it to the second phase which involves a larger group of volunteers for three years.

Once proved successful, the Indian HIV/AIDS vaccine will go to third –and most significant phase — of testing its strength and efficacy in real-time patients suffering from the disease. Related: HIV drug consumption to double in India as 1 lakh more patients go for ART

TRC and NARI started the 18-month trial in 2009 with 16 volunteers in each centre. The groups were further divided into two for a double blind’ study. While one group was given injections thrice, the other was given injections four times. One of this was a placebo, the other the vaccine. Neither the volunteers nor the scientists knew which group received the vaccine.

The earlier round of clinical trials carried out by TRC in August 2008 was significant because the vaccine passed the safety test. Yet, it was not as strong as we expected it to be, according to the study’s principal investigator Dr V R Ramanathan, senior deputy director, TRC.

The researched then boosted the vaccine by adding another DNA vaccine candidate, which was tried by scientists in the USA.

“We hope this combination will yield better results. All the volunteers received the injections in the first six months. They were asked to come on the 9th, 12th and 18th month for follow-up. We have completed the 12th month follow-up. So far, we have not seen any toxic reactions,”  NARI director Dr RS Paranjape was quoted as saying. The last visit for follow-up will be in December. We will then unblind’ the study and the results will be available by February, according to him.

However, the vaccine may take several yeras before it reaches markets. Phase -2 is only a larger study with a sample size that may extend up to 500. This will take at least three years. The vaccine will then be upgraded for the next level of trial, where volunteers from high-risk groups will also participate. This is where we would know if the vaccine is really efficient in stopping the virus from entering the body, said Dr Ramanathan.

India currently figures among the top 20 countries with the highest incidence of HIV infection around the world.

The number of facilities with HIV testing and counselling in the country has also increased from 4,269 in 2007 to 4,817 in 2008.

The number of people receiving HIV treatment has increased 12-fold globally, since 2003Since 2003. The cost needed for HIV treatment this year is pegged around $ 9 billion, according to UNAIDS.

Across the globe, an additional 1.2 million HIV patients were started on the life-saving anti-retroviral treatment (ART) in 2009 — the highest number of infected availing of this medicare in a single year.

An estimated 5.2 million HIV patients were receiving this life-saving treatment at the end of 2009, according to WHO estimates