Annual Report 2015
2015 was a year of extraordinary activity for SATVI. The clinical and laboratory teams completed three Phase 1-2 trials of novel TB vaccines in adult and infant study populations; finished enrolment in two large Phase 2 TB vaccine trials, including a proof of concept efficacy trial of the GSK M72 candidate vaccine in TB-infected adults and a Prevention of Infection (POI) trial of the Sanofi H4 candidatevaccine and BCG in adolescents; and started recruitment for clinical trials of a recombinant BCG vaccine (VPM-1002) in newborns; a live attenuated Mycobacterium tuberculosis vaccine (MTBVAC) in adults and infants; and an adjuvanted subunit vaccine (ID93+GLA-SE) in recently treated TB patients.
Our research remains firmly focused on development of a new TB vaccine that is safe and effective in infants, children, and adults, including persons who are HIV infected. At the same time, we have made a concerted effort to diversify our TB research portfolio. After a lengthy preparation period, we enrolled our first participants into an AIDS Clinical Trial Group (ACTG) household contact study of multidrug-resistant TB patients. The study marks the first of several TB diagnostic and therapeutic studies in the SATVI pipeline. SATVI’s research outputs continue to increase, with a total of 28 papers published by SATVI authors in 2015, including the report of a first-in-human trial of the adjuvanted subunit vaccine H56:IC31 (Staten Serum Institut).
The year ended on a high note, with the award of a multimillion dollar grant for a clinical trial that will test a screen and treat strategy to target preventive therapy for persons with a transcriptomic signature of risk for TB disease. CORTIS (The Correlate of Risk Targeted Intervention Study) will start in mid-2016. We also led a successful application to a joint SAMRC-NIAID call to establish the Clinical Research Unit for Advancement of Tuberculosis Biomarker-Targeted Interventions, part of the new RePORT SA network.
We also bade farewell to Dr Zameer Brey, who joined the Bill & Melinda Gates Foundation’s South Africa Office, and we welcome Dr Masooda Kaskar, who joins us from Novartis to take up the reins of the COO position in 2016.
A big ‘thank you’ goes to the Breede Valley community in which we work, our study participants and their families, who are deeply invested in our research to prevent and cure TB. The achievements of the past year would also not have been possible without the help of our many local and international partners, and we begin 2016 in the same spirit of active and equal collaboration towards a shared goal –“a World without TB”.
Associate Professor Mark Hatherill