The Prevention of Tuberculosis Recurrence Consortium (POR TB) held its annual meeting virtually on 15 November 2022. The meeting included presentations from work package leaders and clinical trial sites in South Africa and Tanzania, where the study is conducted.
After delays related to the SARS-CoV-2 pandemics, the POR TB Phase II trial to determine efficacy of the multistage vaccine H56:IC31 for prevention of recurrent TB disease is fully enrolled with 831 randomised trial participants. A protocol amendment to extend the project for 21 months was approved by EDCTP. The presentations from clinical trial sites focused on participants’ retention, reduction of losses-to-follow-up and ascertainment of clinical trial endpoints. EDCTP Senior Project Officer Dr Michelle Helinksi attended the meeting virtually. The POR TB trial results are expected on the first quarter of 2024.
Important discussions on how to optimise the scientific output of the consortium took place at the meeting. These included:
validation of the POR trial design for testing TB vaccine candidates;
considerations about different scenarios upon clinical trial unblinding regarding vaccine efficacy;
how to proceed in case of lack of vaccine efficacy with potential analyses on correlates of risk for recurrent TB;
the contribution of TB relapses by the same bacteria versus reinfections by different bacteria for the primary endpoint of recurrent TB during trial follow-up;
secondary papers of scientific relevance using the data collected from trial participants.