Early data shows that the H56:IC31 candidate vaccine did not provide protection against TB recurrence
The Statens Serum Institut (SSI) announced today that they will stop the development of the H56:IC31 tuberculosis (TB) candidate vaccine. The first analyses of data from the phase 2b vaccine trial, conducted under the EDCTP-funded POR TB study, show that the vaccine was well tolerated and was immunogenic. However, the primary analysis showed it did not provide protection against TB recurrence.
“This was a well-conducted study by a Europe-Africa team of highly experienced researchers. Although the results are disappointing, the data will inform decisions about the development of future TB vaccines and as such valuable lessons can be learned from this trial.”
Dr Pauline Beattie, EDCTP Operations Manager and Scientific Advisor
The research team has informed the study participants and national authorities in Tanzania and South Africa of these results. Detailed clinical and lab analyses are underway to understand the mechanisms leading to TB recurrence. The researchers will share all findings with the scientific community to help advance the field. Developing a safe and effective vaccine against TB remains a global priority. EDCTP encourages all stakeholders to work together in the fight against TB.
Read the full statement from the POR TB Consortium.
Read more about EDCTP’s portfolio of TB vaccine projects.