Japan’s National Institute of Biomedical Innovation (NIBIO), Aeras and Create Vaccine Company (CREATE) have entered into a collaboration agreement for the preclinical and clinical development of new mucosal tuberculosis (TB) vaccines.

The deal will advance vaccine candidates based on the rhPIV2 technology via preclinical stages with an aim to advance to safety and immunogenicity testing in clinical trials.

Under the deal, the partners will collaborate jointly to establish development criteria and evaluate progress through agreed upon development milestones, which will include the characterisation of new vaccine constructs with a range of antigens, the conduct of immunology studies to identify the most promising novel vaccines, and the establishment of current good manufacturing practices (cGMP).

CREATE president Koichi Kozuki said: "The exciting partnership among NIBIO, Aeras and CREATE will accelerate development efforts for clinical application of new TB vaccines to the patients who need it."

The new TB vaccines will be based on NIBIO’s human parainfluenza type 2 (rhPIV2) vector technology created by Tsukuba Primate Research Center at NIBIO.

The agreement is supported via a grant from the Global Health Innovative Technology Fund (GHIT), a new partnership formed to help international partnerships that allow Japanese technology, innovations, and insights to play a more direct role in reducing disparities in health.

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"Further studies contribute to the ultimate goal of establishing a new vaccine strategy that can definitely prevent TB."

Aeras president and CEO Tom Evans said these will be important candidates; designed to target mucous membranes to keep TB from entering the lungs.

"This type of collaboration among global experts is exactly the approach needed to find an effective vaccine that will end tuberculosis in Japan and around the world," Evans said.

CREATE is a joint venture firm formed by Dainippon Sumitomo Pharma and Japan BCG Laboratory to develop and market TB vaccines developed in partnership with NIBIO and Aeras.

NIBIO director of Tsukuba Primate Research Center Yasuhiro Yasutom said: "Further studies contribute to the ultimate goal of establishing a new vaccine strategy that can definitely prevent TB."

Image: TB exacts its greatest toll on individuals during their most productive years, from ages 15 to 44. Photo: courtesy of