EDCTP funded clinical trial testing new tuberculosis vaccine initiates vaccinations
18 DECEMBER 2019: Statens Serum Institut (SSI) in Copenhagen, Denmark, is the coordinator of a consortium which has been awarded a substantial grant from the European & Developing Countries Clinical Trial Partnership (EDCTP) supported by the European Union.
The grant finances a clinical trial in South Africa and Tanzania of a new and promising tuberculosis (TB) vaccine candidate H56:IC31* developed by SSI. SSI and Aeras Global TB Vaccine Foundation NPC (a South African affiliate of IAVI) are co-sponsors of the trial. The consortium consists of partners from South Africa, Tanzania, Italy and Denmark: the South African Tuberculosis Vaccine Initiative (SATVI) (Cape Town, South Africa), University of Cape Town Lung Institute (Cape Town, South Africa), TASK Applied Science (Cape Town, South Africa), the Aurum Institute (Johannesburg, South Africa), the National Institute for Medical Research (NIMR; Mbeya, Tanzania), Ospedale San Raffaele (Milan, Italy), the Aeras Global TB Vaccine Foundation NPC (Cape Town, South Africa), and SSI (a governmental research institution under the Danish Ministry of Health) (Copenhagen, Denmark).
Rationale: Over the last two centuries, TB is estimated to have killed one billion people, and it remains the world’s most lethal infectious disease. The highest incidences of TB infection a nd disease in the world are encountered in sub-Saharan Africa. South Africa reports one of the highest incidences in the world with 567 incident cases per 100.000 in 2017, and TB was South Africa’s leading cause of death in 2015. In 2016, 6.5% of all deaths in South Africa were attributed to TB. Following successful treatment of TB disease, recurrence rates vary between 4-8%, and the majority of recurrences occur within the first year after completion of TB treatment. This is a significant issue for patients and TB control. Multidrug- and extensively drug-resistant TB (MDR- and XDR-TB) are growing threats. An effective TB vaccine will reduce the incidence of TB, resulting in fewer people requiring treatment and thus reducing antibiotic resistance. Also, because TB vaccines are expected to be equally effective against drug-sensitive and drug-resistant TB strains, vaccines could be key to controlling the TB epidemic and containing the spread of resistant strains.
The current clinical trial is an innovative type of TB vaccine Phase IIb efficacy trial, using the prevention of TB recurrence post-TB treatment as an indicator of the ability of a vaccine to prevent TB disease in the broader healthy population. In the clinical trial 900 participants will be vaccinated with either H56:IC31 or placebo at the end of their TB treatment. Participants will be followed-up for one year, which is the period associated with the highest risk of recurrent TB. The trial investigates if vaccination with H56:IC31 added at the end of standard TB treatment is better at preventing recurrent TB than standard drug treatment alone. All sites in the clinical trial are now randomizing and vaccinating participants. Enrollment of participants in the clinical trial is expected to be completed by July 2020.
"This important trial will help us understand if vaccination can contribute to improved treatment outcomes, and potentially to shorter treatment regimens.”Profesor Mark Hatherill
Dereck Tait, MBChB, Senior Medical Director at Aeras Global TB Vaccine Foundation NPC said, “We are pleased to partner in this innovative clinical trial and grateful to EDCTP for its support. If H56:IC31 is efficacious in preventing TB recurrence, this would be a major advance for TB. Benefits would accrue to patients who would be less likely to suffer from recurrences and to TB control programmes for which recurrent TB is a major burden on resources.”
We are pleased to partner in this innovative clinical trial and grateful to EDCTP for its support. If H56:IC31 is efficacious in preventing TB recurrence, this would be a major advance for TB-
Dereck Tait
Media contact details
For further information please contact Kjersti Moen, SSI, at kjmo@ssi.dk or +45 32688657, or Rose Catlos, IAVI, at rcatlos@iavi.org or +1 2128471049.
This project is part of the EDCTP2 programme supported by the European Union.
* IC31® is a vaccine adjuvant owned by the biotech company Valneva SE.
About IAVI: IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at www.iavi.org.