HANOVER — Dartmouth College’s Geisel School of Medicine and Aeras, a global nonprofit biotech, have joined forces to conduct a trial of a new vaccine for tuberculosis, one of the world’s deadliest diseases.
The vaccine, known as DAR-901, is related to the vaccine SRL-172, previously shown by Dartmouth investigators to decrease the risk of TB in a trial known as the DarDar Trial.
Aeras said in the announcement Wednesday that DAR-901 will be added to Aeras’ portfolio of TB vaccines in clinical development.
“The world desperately needs new vaccines to prevent the global spread of TB. We are pleased to join forces with Dartmouth’s Dr. Ford von Reyn and the DAR-901 partners in manufacturing the candidate and supporting the first clinical trial,” Aeras President and CEO Dr. Tom Evans said in the announcement.
The Aeras announcement coming just before World TB Day, which falls on Monday, is exciting, said von Reyn, professor of medicine at Geisel School of Medicine and the principal investigator.
Partnering with Aeras modernizes the production of the booster vaccine, von Reyn said, and is also a vote of confidence from the vaccine manufacturer.
There is an international effort to eradicate TB by 2050, von Reyn said. The only way to accomplish this is by continuing to attack TB with antibiotics and other known medical treatments as well as introduce an effective booster vaccine,.
Effective in those with HIV
The Dartmouth group that has been working on the booster is enthusiastic about its potential, he said.
“Of the 40 or so vaccines in development, we’re the only one that’s shown effectiveness in humans.”
“The Dartmouth group here has been working on this vaccine basically since the mid-’90s, and we went through the typical stages testing new vaccine,” von Reyn said.
Phase 3 of the related SRL-172, known as the DarDar Trial, was a controlled trial that included 2,000 HIV-infected patients in Tanzania, half of whom received the booster.
According to the announcement, “The DarDar Trial demonstrated that the new vaccine was safe and 39 percent effective in preventing definite TB in HIV-infected adults with a CD4 cell count of at least 200 cells/ml.
“We liked that result, and we thought that if these had been used in people without HIV it probably would have been twice as affective,” von Reyn said.
“If you have HIV you are particularly vulnerable to TB infection,” von Reyn said, additionally, “TB is the leading killer of AIDS patients.”
Dartmouth’s new study
In April the new study will start and will be conducted at Dartmouth, von Reyn said.
Because it is a booster, this new trial drug DAR-901 will be evaluated as a booster vaccine in adolescents and adults who are foreign-born. Most other countries, unlike the United States, administer the TB vaccine to infants. The effects of the vaccine end after 10 to 15 years, von Reyn said.
Other studies would take place in countries where TB is more prevalent.
“Our goal is to demonstrate that this is an effective booster vaccine that could help reduce the burden of TB disease throughout the world,” von Reyn said.
More than 8.5 million people each year develop active TB, and 1.3 million people die of the disease.
The Dartmouth team has been focused on research to combat TB since von Reyn’s tenure with the World Health Organization’s AIDS program in 1987.
“It’s heartening to see Aeras and Dartmouth join forces to advance this vaccine candidate. Its precursor —SRL-172 — is the only new vaccine to have shown evidence of protection against TB in humans and in particular in HIV-infected persons, the most vulnerable group. This is an important step forward in the global battle against TB,” Professor Ajit Lalvani, director of the Tuberculosis Research Centre, National Heart and Lung Institute at Imperial College London, said in the announcement.