Research needed to overcome stunning shortcomings in TB tools

John Donnelly, a writer working with the GHTC, is blogging following our trip to visit global health research projects in Kenya. This is his third post from the field.

KISUMU, Kenya – The shortcomings in the tools to fight tuberculosis (TB) are stunning.

There is no effective TB vaccine beyond childhood. The most common TB diagnostic tool was developed in the 1880s and fails to detect the bacterium in half of the cases. And the drugs needed to treat TB are also ancient – the most recent ones were developed more than 40 years ago.

As a result, resistance to TB drugs has run wild in parts of the world. There are an estimated 440,000 cases of multi-drug resistant TB globally, and at least 58 countries have reported cases of extensively drug resistant TB, which can be incurable.

“TB is an example of what happens if you fail to invest in research,” said Kevin Cain, TB Branch Chief at the KEMRI/CDC Research and Public Health Collaboration in Kisumu. The Kenya Medical Research Institute (KEMRI) and the US Centers for Disease Control and Prevention (CDC) have been partnering together in the country for more than 30 years. “It means you end up with a diagnostic tool that is over a century old, you are using drugs from the 1960s and older. And you end up with the situation we are in: many cases of extensively drug-resistant TB, which can be untreatable.”

But in western Kenya, and in several other research sites around the world, clinical trials are ongoing for a new vaccine, drugs, and diagnostics. On GHTC’s trip to Kenya, we were able to see participants of a Phase II trial of a TB candidate sponsored by Aeras, a GHTC member and non-profit product development partnership (PDP) dedicated to the development of an effective and affordable TB vaccine for all age groups.

Currently, the Bacille Calmette-Guérin (BCG) vaccine, which is over 80 years old, is only partially effective; it provides some protection against severe forms of pediatric TB, but is unreliable against adult pulmonary TB.

The trial in western Kenya involves giving two doses to children: one on the initial visit and a second 28 days later. Dr. Samuel Ouma, a physician working on the TB trial, said that 144 children have enrolled at his clinic in Boro. The trial offers free health care to the babies enrolled in the study.

We met with one of the mothers of the children in the study. Sharon Akinyi Olunga, 27, said she asked many questions before enrolling her baby, Winfrey Atieno Juma, now 13 months old. She said she was very happy she had enrolled her daughter.

“It’s good for our babies,” she said. “I loved that my child should go into this research project first because if anything happened to her, whether she was sick with a cold or pneumonia, she would immediately receive free medical care. Here, funding for medical care is really difficult to get. So it put me at ease.”

Olunga said there was another reason she wanted her daughter to be part of the trial: it served a greater good for children around the world. “I think of so many babies, so many children in Africa and around the world, have been helped by vaccines,” she said. “If this vaccine works, that means all those children will be helped by my baby’s participation. That makes me feel very good.”

Watching Olunga was her grandmother, Hilda Auma Juma, who was in her 70s. Juma also said she was glad to see medical research in her village and in neighboring villages.

“I am happy because it helps the health of all babies,” said Juma, who had nine children. She said health care has dramatically improved for mothers and children compared to the situation a half-century ago.

“In my time, when I gave birth, mothers only had the faith of God to take care of the babies,” Juma said. “Now mothers have all these vaccines. Babies and children are living. We hope we may soon have more vaccines. It’s wonderful.”