Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Data from Historic Phase IIb Clinical Trial for Tuberculosis Vaccine Candidate Published

Published: Monday, February 04, 2013
Last Updated: Monday, February 04, 2013
Bookmark and Share
Vaccine candidate did not provide statistically-significant protection in preventing TB disease in infants previously vaccinated with BCG.

Data were published in The Lancet today from a Phase IIb clinical trial evaluating the safety and efficacy of MVA85A in preventing tuberculosis (TB) in infants. MVA85A is a TB vaccine candidate designed to boost immune responses already primed by the Bacille Calmette-Guérin (BCG) vaccine, the currently licensed and widely used TB vaccine.

Data show that a single dose of MVA85A is not sufficient to confer statistically significant protection against TB disease or infection in infants who had been vaccinated at birth with BCG. There were 32 cases of TB disease in the infants that received BCG + MVA85A compared with 39 cases of disease among those receiving BCG + placebo. Non-significant vaccine efficacy was measured at 17.3% (95% CI -31.9% to 48.2%) at study completion. The vaccine candidate also did not provide statistically significant protection from infection with Mycobacterium tuberculosis, the bacterium that causes TB, which was a secondary efficacy endpoint.

“Although the results of this first efficacy trial of a new TB vaccine are not what we had hoped for, further analysis of the data should reveal a great deal about how the body’s immune system protects against TB and what is necessary to develop an effective vaccine,” said senior author Prof. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow at the University of Oxford and the original developer of the vaccine. “The results from this study should let us know far more about the type and level of immune response required, and that will boost future efforts to develop an effective TB vaccine by Oxford and other researchers throughout the world. The difficulty of this task is one reason why there has not been a new TB vaccine since BCG was developed more than 90 years ago, but one is still urgently needed and I’m not about to give up now.”

MVA85A is the first novel, preventive TB vaccine candidate since BCG to complete a Phase IIb safety and efficacy study.

The study was successful in that the vaccine was well tolerated, there was no evidence of any harm to the trial participants, and it gave a clear answer. This study also showed it is possible to conduct a large infant efficacy clinical trial in an area of high TB incidence with robust endpoints for detecting disease, something that is expected to greatly benefit future testing of TB vaccine candidates.

Funding for this clinical trial was provided by Aeras, a nonprofit biotech with a social mission to develop TB vaccines, The Wellcome Trust, and the Oxford-Emergent Tuberculosis Consortium (OETC), a joint venture between the University of Oxford and Emergent BioSolutions. This Phase IIb study was sponsored by Aeras and conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative (SATVI). The vaccine was originally developed and investigated by the University of Oxford.

It is anticipated that further analysis of the data and samples collected will be conducted for information that may be helpful for the development of new vaccine candidates. For example, blood samples will be used to identify markers that can predict whether a child will develop TB disease in the future. These biomarkers are termed “correlates of risk” and may substantially aid the development of new vaccines and contribute to different trial designs in the future.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Project to Focus on Link Between Immune System and Brain Disorders
Researchers to investigate whether mood disorders, such as depression, and neurodegenerative diseases, such as Alzheimer’s, could be treated by targeting the immune system.
Monday, December 22, 2014
£5m Programme to Investigate Brain Networks
The studies in primates will look at how networks of millions of neurons in the brain give rise to key functions.
Friday, May 16, 2014
Faster Visa Endorsement will Support International Mobility for Top Researchers
This visa route is designed for the brightest and best bringing them from outside the European Economic Area to the UK.
Monday, April 07, 2014
Scientific News
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Advancing Protein Visualization
Cryo-EM methods can determine structures of small proteins bound to potential drug candidates.
Breast Cancer Drug Hope
A drug for breast cancer that is more effective than existing medicines may be a step closer thanks to new research.
Harnessing Nature’s Vast Array of Venoms for Drug Discovery
Scripps scientists have developed a method for rapidly identifying venoms.
A New Platform for Discovering Antibiotics
Harvard chemists hope to shorten time, difficulty in measuring their effectiveness, potential.
The Need for Speed
Evaluating MALDI-TOF as a high-throughput screening technology for the pharmaceutical industry.
Antarctic Sponge Extract Kills MRSA
New findings may provide opportunity for developing new drugs to fight dangerous bacteria currently highly resistant to treatment.
US-India Collab Finds Molecular Signatures of Severe Malaria
Study may be a significant advancement in understanding the causes of severe malaria.
Novel Way to Prevent Deadly Bacterial Infections
Monash scientists may have found a way to stop deadly bacteria from infecting patients. The discovery could lead to a whole new way of treating antibiotic-resistant “superbugs”
Gene Expression Controls Revealed
Researchers have modelled every atom in a key part of the process for switching on genes, revealing a whole new area for potential drug targets.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!