Final child vaccinated in clinical trial of new TB vaccine

May 4, 2011
Final child vaccinated in clinical trial of new TB vaccine
An infant vaccination. Credit: Wellcome Images.

The final participant in a clinical trial to assess the safety and efficacy of a new vaccine against tuberculosis (TB) has been vaccinated.

The vaccination of the final child marks a significant milestone in the development of the MVA85A/AERAS-485 candidate, the most advanced of any of the new generation of preventative TB vaccines currently being investigated.

Tuberculosis kills 1.8 million people per year, and more than 2 billion people worldwide are infected with TB - approximately one in every three people on the planet. Bacille Calmette-Guérin (BCG) is currently the only available vaccine against the disease. It provides some protection against TB in children; however, it provides only variable protection against pulmonary TB, which accounts for most of the worldwide disease burden. New vaccines, therefore, are urgently needed to combat the problem.

The new vaccine, called MVA85A/AERAS-485, is given to children after the BCG and is designed to boost the body’s immune response to the vaccine, improving the level of protection. It was originally developed at the University of Oxford by Dr Helen McShane, a Wellcome Trust Senior Clinical Research Fellow, working with Dr Sarah Gilbert, a Reader in Vaccinology, and Professor Adrian Hill, a Wellcome Trust Principal Research Fellow.

A double-blinded phase IIb trial of MVA85A/AERAS-485 was launched in 2009 and conducted at the TB vaccine research site of the South African Tuberculosis Vaccine Initiative (SATVI) of the University of Cape Town, in partnership with Aeras, the Oxford-Emergent Consortium Ltd and the Wellcome Trust.

Dr Michele Tameris, the Vaccine Trials Manager at the SATVI Worcester site, said: "Our team has worked tremendously hard to vaccinate our target of 2784 babies in just under two years. The trial is significant for being the most advanced of all TB vaccine candidates being tested in clinical trials, as well as the most babies enrolled in any TB vaccine trial. As a phase llb trial, it is designed to test for safety in a large group of babies as well as to see whether it works to prevent TB. It has already been successfully tested for safety in smaller groups of babies. Understandably, this final vaccination is a proud milestone for SATVI and its partners."

"We are pleased to report that the trial has run smoothly, with no vaccine-related serious adverse events being reported", added Dr Hassan Mahomed, who leads the trial as Principal Investigator and SATVI Co-Director.

"We are extremely proud of this achievement and are eager to see the study results, which are expected to be available in mid-2012," said Dr Helen McShane. "This milestone brings us a step closer to potentially having a new TB vaccine, from which millions of people around the world would benefit."

Following vaccination, babies are being followed up for around two years to see whether the new has provided protection against TB. The study is expected to run until the middle of 2012.

The trial has been part-funded by a Wellcome Trust Strategic Translation Award.

Explore further: Trials begin for 'essential' new TB vaccine

Related Stories

Trials begin for 'essential' new TB vaccine

July 30, 2007

Clinical trials are underway with the first new vaccine against TB in over 80 years. If successful, the tests will have major implications for TB control and could lead to the development of a new vaccine ready to use within ...

TB vaccine enters new clinical trials

April 23, 2009

( -- The world’s leading candidate for a tuberculosis vaccine, developed at the University of Oxford, is to enter Phase IIb proof-of-concept clinical trials, making it the first TB candidate vaccine for more ...

New TB booster shows promise

March 16, 2010

A booster shot appears to improve tuberculosis (TB) resistance in previously vaccinated adults, according to new research in South Africa.

New TB vaccine enters clinical testing

September 23, 2010

At an international gathering of TB vaccine researchers in Tallinn today, the Aeras Global TB Vaccine Foundation announced it will initiate a clinical trial of an investigational live recombinant tuberculosis vaccine to be ...

Tuberculosis vaccine passes phase I trial

March 24, 2011

( -- The currently available tuberculosis vaccine BCG is over 90 years old – and its effectiveness is declining. An increasing number of mycobacterial strains are emerging, against which the current vaccine ...

2,784 vaccinations later

April 29, 2011

The two thousand, seven hundred and eighty-fourth baby has been vaccinated today in South Africa as part of a clinical trial of a new vaccine against tuberculosis. The new TB vaccine is the most advanced in development anywhere ...

Recommended for you

Researchers discover a drug for a tropical disease

August 30, 2016

Researchers at the University of Georgia are working to find the fastest way possible to treat and cure human African trypanosomiasis, long referred to as sleeping sickness. By working to improve chemical entities already ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.