As UN Summit Addresses Global Tuberculosis Pandemic, GSK Touts Effective Vaccine

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GlaxoSmithKline (GSK) and the non-profit Aeras reported that their M72/AS01E vaccine candidate significantly cut the rate of pulmonary tuberculosis in HIV-negative adults with latent tuberculosis infection. The results are part of an ongoing Phase IIb clinical trial. The data was also published in the New England Journal of Medicine.

After two years of study, the clinical trial showed the vaccine had an overall efficacy of 54 percent, with some variation reported in different demographic sub-groups. The trial is conducted in areas where tuberculosis is endemic, Kenya, South Africa and Zambia, and has 3,573 HIV-negative adults participating.

In the trial, patients received two doses of either M72/AS01E or placebo 30 days apart. They were then followed for at least two years to look for evidence of pulmonary tuberculosis. In the group receiving the vaccine, 10 patients developed active pulmonary tuberculosis compared to 22 patients in the placebo group.

“These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis,” stated Emmanuel Hanon, senior vice president and Head of R&D, Global Vaccines GSK. “This scientific breakthrough — one of the very few in tuberculosis vaccine development for almost 100 years — has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.”

The trial is sponsored by GSK and in partnership with Aeras, a nonprofit working to develop new and effective TB vaccines. Aeras is funded by the Bill & Melinda Gates Foundation, the UK’s Department for International Development, the Directorate General for International Cooperation in the Netherlands, and the Australian Agency for International Development.

The clinical trial is ongoing and expected to wrap up in 2019.

The news coincides with the United Nations summit. As part of the summit, global representatives are gathering today to discuss initiatives to prevent and treat tuberculosis, which in 2017 took more lives than any other communicable disease. Approximately 1.3 million people died of TB last year. Another 300,000 people with both HIV and TB also died last year, according to the World Health Organization (WHO). The organization estimates about 10 million people worldwide become newly infected each year.

“It really is a global epidemic,” said Tereza Kasaeva, who heads WHO’s program to combat TB, reported U.S. News and World Report.

There is heightened concern about increases in drug-resistant TB strains, many which aren’t correctly diagnosed. “Because of the increasing mobility in society it also affects economically more powerful countries,” said Ralf Otto-Knapp of the German Central Committee to Combat Tuberculosis, reported U.S. News and World Report. “We need a joint political will and the necessary resources to fight tuberculosis effectively.”

Part of the meeting will be to attempt to generate more funding. WHO recently recommended changes to the way drug-resistant TB is treated, “prioritizing oral drugs over injectable medication,” U.S. News and World Report indicated. Doctors Without Borders indicates that oral treatments can have fewer severe side effects, increase cure rates and decrease deaths, “but noted that it requires U.S. pharmaceutical giant Johnson & Johnson, which makes the key drug bedaquiline, to reduce its price in low- and middle-income countries with high rates of drug-resistant TB. The company has already sharply reduced costs for the drug in some countries, but in others, a six-month course of treatment can cost several thousand dollars — far more than most people can afford.”

There have only been two new TB drugs to enter the market in the last 50 years.

There is a TB vaccine which was developed in 1921 called Bacille Calmette-Guerin (BCG). Babies in countries with high TB rates are routinely administered the BCG vaccine. The problem with BCG, however, is that its effects don’t last. And it does not protect against the most common type of TB that affects the lungs of adults and adolescents, which can be transmitted through coughing and sneezing.

Although GlaxoSmithKline’s vaccine is promising, its overall efficacy to date is only slightly better than 50 percent. But the company believes it can do better. “It’s the first time we really tested the biological potential of our vaccine and we think that there is a lot of additional improvement now that we can bring,” Hanon told Reuters.