/ 16 November 2007

On the trail of a new vaccine

Kurnel Plaatjies was having a bad week. He had been starved overnight, had a tube stuffed up his nose and fluid poured down it and sucked out. He had been forced to breathe strange mixtures and made to cough. And now strangers were trying to make friends when all he wanted to do was watch television.

The indignant toddler is a volunteer foot soldier in the world’s most advanced attempt to create a vaccine to stop the spread of tuberculosis. The Bacille Guerin-Camille (BCG) vaccine, created 85 years ago, is fairly effective in preventing extra-pulmonary TB in young children. It is relatively useless in preventing pulmonary forms of the disease — as Kurnel had demonstrated. Despite having had a BCG in infancy, he was probably about to start six months of anti-TB treatment, following in the steps of his father, who was treated two years earlier.

But Kurnel’s sputum and stomach samples will be added to a growing database of TB infection, cure rates and transmission in the Worcester area, where researchers from the South African TB Vaccine Initiative (Satvi) are gearing up to push through six clinical trials of possible vaccines as fast as possible.

Already two vaccines have gone into clinical trials at the trial site, and the other four will follow within a year. Without a better vaccine TB cannot be eradicated from humans, and the burden of TB disease is greater now than at any time in history. The World Health Organisation estimates that a new TB infection occurs every second, with more than 1,5-million people a year dying from the disease. It is the second-biggest killer in South Africa.

Researchers under the leadership of Greg Hussey have been working for years with the Aeras Global TB Vaccine Foundation, local communities and the government to create the infrastructure to test vaccines in the Worcester area. If humanity gets a new TB vaccine before the 100th birthday of the existing one, it will almost certainly be due to the children and adults living in this region of the Western Cape. But even the most optimistic projections are that the earliest date for a TB vaccine is 2014 — if one of the six turns out to be at least as effective, safe and affordable as the BCG.

Aeras is headed by Jerald Sadoff, who previously worked for Merck, one of the ‘big pharma” companies attacked by health activists for high prices and lack of interest in medicines for poorer countries. It is a product development partnership, a global non-governmental organisation set up to function as a business to develop new drugs and diagnostics and to push companies to give it access to the libraries of drugs that might not have made it to the market for reasons unrelated to effectiveness and safety.

Lack of potential profit can lead a pharmaceutical company to lock away a drug in the research archives at the early stages of development rather than risk the multimillion-dollar costs of full testing.

Aeras’s approach is to use a ‘prime-boost” system, where children first have their immune systems alerted — primed — by one vaccination. This is followed by a booster to improve and extend protection.

For the Aeras vaccines, BCG is used as the booster — most children in the Worcester area receive this vaccination shortly after birth, which has added to the area’s attraction as a research site. Another lure is the rate of TB, which is among the highest in the world for reasons that are not yet understood. Five of the vaccines headed for Worcester are booster vaccines — including an oral version that would have the advantage of costing very little. The sixth is a revised form.

A more effective vaccine could save thousands of children from the situation at the other end of the corridor — the ward where Kurnel had his two days of tests. There, in a locked room designed for 40 people, 52 young patients live for weeks and months of in-patient TB treatment.

Most have weekend contact only with their parents and the months of separation take their toll, creating emotional and developmental problems.