Tuberculosis vaccine MVA85A fails to protect babies in new study

FILE - In this Aug. 26, 2009 file photo, a merchant speaks with a woman holding her ill child at a pharmacy in Pailin, Cambodia. The future of a pricey malaria program meant to provide cheap drugs for poor patients may be in jeopardy after health officials clashed over its effectiveness in two new reports. In 2010, the Affordable Medicines Facility for malaria was started by groups including United Nations agencies and the Global Fund to Fight AIDS, Tuberculosis and Malaria. It was a pilot project to subsidize artemesinin combination drugs. Most of the drugs bought were sold in the private sector, where there are few controls on who gets them. But in October 2012, a report by Oxfam, an international charity, labeled the program a failure and said there was no proof it had saved lives because officials didn't track who received the drugs. (AP Photo/David Longstreath, File)

A promising new tuberculosis vaccine has failed to protect infants against the deadly infectious disease that kills more than 1 million people worldwide every year, a new study found.

The world's most advanced tuberculosis vaccine, MVA85A, was designed to improve protection from the only existing tuberculosis vaccine, BCG, which is routinely given to newborns. Though the new vaccine appeared safe, scientists found no proof it prevented the airborne disease.

Previous tests of the vaccine in adults had been promising and researchers said the trial provided useful data to inform future studies. There are a dozen other TB vaccines currently being tested.

Study co-author Dr. Helen McShane, a professor of vaccinology from the University of Oxford who helped develop the vaccine, told the BBC the vaccine "induced modest immune responses against TB in the infants, but these were much lower than those previously seen in adults, and were insufficient to protect against the disease."

Some health officials were discouraged by the results.

"It's pretty disappointing," said Dr. Jennifer Cohn, a medical coordinator at Doctors Without Borders, who was not part of the study. "Infants are at really high risk of TB but this doesn't seem to offer them any protection."

MVA85A was developed at Oxford and was tested in nearly 2,800 infants in South Africa who had already been given a BCG shot, between 2009 and 2011. About half of the babies got the new vaccine while the other half got a placebo.

They were followed for up to three years. In the group that got the vaccine, there were 32 cases of TB, versus 39 cases in the group that got a placebo. The vaccine's efficacy rate was about 17 percent.

No serious side effects related to the vaccine were reported.

The study was paid for by Aeras, the Wellcome Trust and the Oxford-Emergent Tuberculosis Consortium. The results were published online Monday in the journal The Lancet.

"There is much that we and others can learn from the study and the data it has produced," McShane said in a statement. She and colleagues are further analyzing the samples from the trial to better understand how humans become infected with TB bacteria.

McShane and her co-authors wrote that the vaccine could potentially protect adolescents or adults against TB since their immune systems work differently from those of infants. The shot is also currently being tested in people with HIV.

"If this vaccine is effective in adults, that would be hugely valuable because the majority of TB disease and deaths are among adults," said Richard White, an infectious diseases expert at the London School of Hygiene and Tropical Medicine. "But no one knows the answer to that right now."

"A vaccine is likely to be a cost-effective way of preventing TB," he said, comparing the $650 million that has been invested into vaccine development in the past decade versus the $1 billion it currently costs to control the disease.

He also warned the world couldn't afford to ignore the spike in TB and its drug-resistant forms. "There are certain boroughs of London that have higher rates of TB than parts of Malawi," he said. "TB is such a big problem that we really need to throw the book at it."

Tuberculosis is a bacterial disease transmitted from person to person via infected droplets from the throat and lungs of people who have the illness, according to the World Health Organization. Symptoms include coughing, chest pains, weakness, weight loss, fever and night sweats. The disease is currently treated with a six-month course of antibiotics.

An October report from the WHO found world TB rates fell in 2011 to 8.7 million new cases, down from 8.8 million cases in 2010. However, the report acknowledged drug-resistant strains may be spreading as a result of patients not being treated properly.