TB vaccine clinical trials may begin this year in India

TB vaccine clinical trials may begin this year in India

Very little research has been done on tuberculosis (TB) vaccine from the time BCG vaccine came into the market in 1921, until the last few years, says Peg Willingham, Senior Director, External Affairs, AERAS Global TB Vaccine Foundation.

In India, which has a high-burden of TB, particularly drug-resistant TB, the TB vaccine research is moving ahead through the regulatory approval processes at St Johns' Research Institute, Bangalore, India.

The existing BCG vaccine has limited effectiveness in preventing people from TB. The 2009 World Health Organization (WHO) Global Tuberculosis Report which was released on 24 March 2009, says that the incidence of TB per capita continues to go down since 2004 however the decline is just one per cent per year which implies that TB will not be eliminated for centuries if we conduct 'business as usual'. The WHO Report also confirms the notion that there might be more than half a million multi-drug resistant TB (MDR-TB) cases every year. Fifty-four (54) countries have reported extensively drug-resistant TB (XDR-TB), according to this report.

There is no doubt that as TB diagnosis and treatment efforts gets scaled up, the efforts to prevent TB should also get boosted. Alongside the compelling need to push research for new TB diagnostics, drugs and vaccines has to be accelerated.

"Sputum smear microscopy TB test was invented in 1882, so it is not the most technologically advanced way but it is the cheapest way to test TB that's why it is still being used in developing countries," says Peg Willingham. "Unfortunately it detects only 50% of TB cases unless the person is infected with HIV when it detects 20% cases" further explains Peg Willingham.

That is why the AERAS Global TB Vaccine Foundation gave expensive and sophisticated equipment called Mycobacteria Growth Indicator Tube (MGIT) to the Bangalore facility where the TB vaccine clinical trials may commence this year, to accurately diagnose TB. "This is one way in which a clinical trial may benefit the community where the research is taking place because we want to bring in very high standards of diagnosis because we want to get reliable results of a clinical trial" says Peg Willingham.

Presently in India, AERAS Global TB Vaccine Foundation is conducting epidemiological studies to find out how much TB is in the area. Since 2005, they have enrolled 11,000 babies and adolescents, not to give TB vaccine candidate products but to see how much TB is in the area. This information is important to evaluate if it is safe enough to do a large clinical trial in that area. AERAS Global TB Vaccine Foundation is also planning to conduct a Phase I clinical trial at St Johns' Research Institute, India, during the course of 2009, said Peg Willingham.

Just like other clinical trials that have taken place in India, AERAS Global TB Vaccine Foundation also is committed to engage communities through effective community advisory boards (CAB), and raising literacy about clinical trials in the community. "We want all our clinical trials to be conducted at the highest international standards of ethics and quality because we will like our vaccines approved by the United States Food and Drug Administration (US FDA) and such agencies in different countries around the world. So if we did anything to compromise the quality it will be tragic because vaccine will not have good uptake" said Peg Willingham.

In the course of conducting these epidemiological studies, AERAS Global TB Vaccine Foundation has already consistently worked upon involving communities, providing them information about tuberculosis and other related information and services.

In Bangalore for these epidemiological studies to assess the TB incidence in the community, babies are enrolled even before they are born because they get BCG vaccine at birth. "So it entails working with pregnant mothers. One important thing we have found which is very cultural to India, is that mother-in-law is very important in the informed consent process" shares Peg Willingham.

"Babies get the existing BCG vaccine. We follow them for two years and provide check up and medical care and refer them to the treatment as needed" adds Peg Willingham.

Finding information about TB incidence in the proposed site for clinical trial of a TB vaccine is crucial to assess the feasibility of a large-scale clinical trial, as an enormous investment is at stake.

"We are also looking at some other possible partnerships to conduct clinical trials elsewhere in India. We have a manufacturing agreement with SERUM Institute of India" shares Peg Willingham.

The TB vaccine research will take at least another seven years before any vaccine can reach the market. Activist Ezio Santos Filho said that there is a gap of USD 2 billion every year to push research and development of new diagnostics, drugs and vaccines. Along with pushing for new tools to fight TB, there is a clear need to scale up high-quality existing TB diagnostics, mobilize communities to test for TB and successfully complete treatment, scale up measures like infection control in congregated settings, provide isoniazid preventive therapy (IPT) wherever possible, and continue advocating for new TB diagnostics, drugs and vaccines.

- Bobby Ramakant