ROCKVILLE, Md., July 11, 2018 /PRNewswire-USNewswire/
-- Aeras, a nonprofit organization dedicated to developing
vaccines against tuberculosis (TB), today announced the publication
of the full results from a Phase 2, randomized, controlled clinical
trial of two TB vaccines— the currently available BCG vaccine and
an investigational vaccine, H4:IC31—in the New England Journal
of Medicine (NEJM).
This proof-of-concept study showed that vaccination can reduce
the rate of sustained TB infections in a high-transmission setting,
such as in uninfected, healthy adolescents in the Western Cape of
South Africa where the study was
conducted. In the trial, revaccination with BCG significantly
reduced sustained TB infections in adolescents with a 45.4% vaccine
efficacy. H4:IC31 also reduced sustained infections, although not
at statistically significant levels, showing 30.5% vaccine
efficacy. However, the trend observed for H4:IC31 is the first time
a subunit vaccine has shown any signal that it may be able to
protect against TB infection or disease in humans. In the trial, TB
infections were measured by a blood test (QuantiFERON-TB Gold
In-Tube (QFT)) converting from negative to positive, and sustained
infections were defined by a QFT test that remained positive for at
least six months.
Jacqueline Shea, PhD, Chief
Executive Officer at Aeras, said: "With this study, we showed that
vaccines against TB infection can work. The results highlight the
importance of investing in new approaches to fighting the leading
infectious disease killer and to evaluating new concepts in
clinical trials. Further, the collaborative effort established
between industry leaders, nonprofits and clinical sites during this
trial showed how powerful combining such forces can be for
developing new interventions against a global health threat. The
BCG results are important findings with significant public health
implications that could lead to saving millions of lives. Likewise,
the novel prevention-of-infection trial design can be used to
inform clinical development of new vaccine candidates before entry
into large-scale prevention-of-disease efficacy trials. We are very
grateful to the trial participants and our partners and funders who
enabled the conduct of this trial."
Initial results from the study were presented at the
5th Global Forum in New Delhi,
India in February 2018.
BCG is the only licensed tuberculosis vaccine available
globally. H4:IC31 is an investigative subunit vaccine candidate
being developed jointly by Aeras and Sanofi Pasteur, the vaccines
business of Sanofi (EURONEXT: SAN) (NYSE: SNY), and the Statens
Serum Institut. The clinical trial was funded by Sanofi Pasteur,
the United Kingdom's Department
for International Development, The Bill & Melinda Gates
Foundation and Aeras. The clinical trial was conducted at the South
African Tuberculosis Vaccine Initiative (SATVI) at the University
of Cape Town and at the
Emavundleni Research Centre (part of the Desmond Tutu HIV Centre).
The study was approved by the Medicines Control Council of
South Africa and the relevant
local independent ethics committees.
About TB
Tuberculosis is designated a priority infectious disease by the
World Health Organization (www.who.int/tb/en/). It causes more
deaths than any other single infectious agent and is increasingly
characterized by antimicrobial resistance. There were 10.4 million
new cases of TB in 2016 and 1.7 million deaths.
About Aeras
Aeras is a nonprofit organization advancing the development of
new tuberculosis vaccines for the world in partnership with other
biotech, pharmaceutical and academic organizations. Aeras is
primarily funded by The Bill & Melinda Gates Foundation, the UK
Department for International Development (DFID), and other parties
committed to ending the TB epidemic. Aeras also receives support
from the U.S. government and through partnerships and
collaborations with universities and pharmaceutical companies
around the world. Aeras is headquartered in Rockville, Maryland (USA), with a clinical
development and operations office in Cape
Town, South Africa. For more information, please visit
www.aeras.org.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
About Statens Serum Institut (SSI)
Statens Serum Institut (SSI, Copenhagen, Denmark) is a public institution
under the Danish Ministry of Health, with a mission to reinforce
health through disease control and research. Since 1902, SSI has
been an integrated part of Danish and international health
services, ensuring preparedness against infectious diseases and
biological threats as well as control of congenital disorders. With
more than 600 employees, SSI is one of Denmark's largest research institutes.
About South African Tuberculosis Vaccine Institute (SATVI)
SATVI is a world leader in TB vaccine clinical research located
within the Health Sciences Faculty at the University of
Cape Town. The goal of SATVI is
the development of new and effective vaccination strategies against
TB through conduct of clinical trials of new vaccine candidates and
immunology studies to better understand risk for and protection
against TB. For more information visit www.satvi.uct.ac.za.
About Desmond Tutu HIV Foundation
The Desmond Tutu HIV Foundation, housed within the Desmond Tutu
HIV Centre at the University of Cape
Town, is committed to the pursuit of excellence in research,
treatment, training and prevention of HIV and related infections in
South Africa.
Fully self-funded by grants and other investigator raised funds,
its vision for the future includes the continuation of current
TB/HIV related work of treatment, care, prevention and education
particularly in the most vulnerable populations, whilst staying
abreast of new developments and continuing to contribute to cutting
edge information in HIV and TB public health, social and clinical
research.
For more information, contact:
Preeti Singh at psingh@burness.com
or +1 301-280-5722
Lori Weiman at lweiman@aeras.org
or +1 301-547-2955
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