Phase IIb trial of TB vaccine initiated

Aeras, a nonprofit developer of effective tuberculosis vaccines, and the Oxford-Emergent Tuberculosis Consortium announced the start of a Phase IIb trial on Thursday for a new investigational tuberculosis vaccine for people living with HIV.  

The proof-of-concept efficacy trial of the vaccine will be conducted at research sites in South Africa and Senegal with primary funding support from the European and Developing Countries Clinical Trials Partnership. This is the first proof-of-concept efficacy trial in people infected with HIV using MVA85A, which is being developed by OETC and Aeras.

The organizations expect the trial to generate important immunogenicity, safety and efficacy data about the vaccine. The trial will test the vaccine candidate in approximately 1,400 adults between the ages of 18 and 50 who are infected with HIV.

“Clinical trials of new vaccines against tuberculosis must be an urgent priority on our agenda, as too many lives are lost to TB, especially among people living with HIV,” Michael Cashman, a member of the European Parliament, said. “I recently visited a clinical trial site of this vaccine candidate in infants in South Africa, and I was impressed with the progress. I am anxious to see a new TB vaccine licensed, and I am proud that European Union member states are investing in this critically-important work.”

Aeras is the sponsor of the trial with significant funding provided by EDCTP, a pan-European body that supports multicenter projects which combine capacity building, clinical trials and networking.

“The TB and HIV co-epidemic is devastating, requiring a concerted global response. EDCTP in partnership with Aeras, OETC and others is committed to accelerate research and development of this promising vaccine against tuberculosis by co-financing the clinical trial as an essential part in its evaluation," professor Charles Mgone, the executive director of EDCTP, said.

Tuberculosis kills 1.7 million people per year, while more than two billion people worldwide are infected with TB, which is approximately one out of every three people on the planet. Those infected with HIV living in countries with high TB prevalence are 20 times more likely to develop TB than those who are HIV-negative.

“Together with our partners, Emergent BioSolutions is proud to be leading the development of a new vaccine to defeat TB, one of the world’s deadliest infectious diseases," Fuad El-Hibri, the chairman and CEO of Emergent BioSolutions, said. "This trial is particularly critical because of its focus on adults living with HIV. If we are successful, MVA85A will help make the dream of a world free from TB a reality."