Satellite Banner
Technology
Networks
Scientific Communities
 
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 3,200+ scientific posters on ePosters
  • More Than 4,800+ 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

Five New Breast Cancer Genes Found
Discovery of mutations paves the way for personalised treatment of breast cancer.
Tuesday, May 03, 2016
How Black Fever Beats Drugs
For drug resistance, sometimes it just takes two (extra DNA base pairs).
Wednesday, March 23, 2016
Gene Expression: A Snapshot of Stem Cell Development
New genes found that regulate development of stem cells.
Monday, October 05, 2015
New Research will Show How the Environment Could Change the Way We Eat
A new study funded by the Wellcome Trust will investigate how environmental changes over the next 20-30 years may impact the way we eat, in the UK and worldwide.
Thursday, July 16, 2015
Single Cells Seen In Unprecedented Detail
Parallel sequencing of DNA and RNA provides insight into secret world of cells.
Wednesday, April 29, 2015
The First Fine-Scale Genetic Map Of The British Isles
Many people in the UK feel a strong sense of regional identity, and it now appears that there may be a scientific basis to this feeling, according to a landmark new study into the genetic makeup of the British Isles.
Thursday, March 19, 2015
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
Ability Of HIV To Cause AIDS Could Be Slowing
Research indicates that HIV is becoming less virulent.
Tuesday, December 02, 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
Lonely Bacteria are More Likely to Become Antibiotic-resistant
Scientists from the University of Manchester have discovered that microbes in smaller groups are more likely to mutate, resulting in higher rates of antibiotic resistance.
Wednesday, April 30, 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
Stem Cell Transplant Repairs Damaged Gut in Mouse Model of IBD
The findings pave the way for patient-specific regenerative therapies for inflammatory bowel diseases such as ulcerative colitis.
Friday, October 18, 2013
New Foot-and-Mouth Vaccine Signals Huge Advance in Global Disease Control
New FMDV vaccine designed to trigger optimum immune response.
Friday, March 29, 2013
Discovery of Molecular Pathway of Alzheimer's Disease Reveals New Drug Targets
The study gives the most detailed understanding yet of the complex processes leading to Alzheimer's.
Wednesday, November 21, 2012
Wellcome Trust and MRC Invest £13m to Create a New National Stem Cell Resource
The Wellcome Trust and Medical Research Council today announced a £12.75 million initiative to create a catalogue of high-quality adult stem cells (iPS cells).
Wednesday, November 07, 2012
Scientific News
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
Connectome Map More Than Doubles Human Cortex’s Known Regions
Researchers at NIH have developed software that automatically detects the “fingerprint” of each of these areas in an individual’s brain scans.
Discovered Through ‘Big Data’ Analysis
Researchers at the SBP have identified over 100 new genetic regions that affect the immune response to cancer.
Human Stem Cells to Rapidly Generate Bone, Heart Muscle
A new study shows that combining positive and negative signals can quickly and efficiently steer stem cells down complex developmental pathways to become specialized tissues that could be used in the clinic.
New Mechanism of Tuberculosis Infection
Researchers at UTSW Medical Center have identified a new way that tuberculosis bacteria get into the body, revealing a potential therapeutic angle to explore.
New Therapeutic Targets For Small Cell Lung Cancer Identified
Researchers at UTSW Medical Center have identified a protein termed ASCL1 that is essential to the development of small cell lung cancer and that, when deleted in the lungs of mice, prevents the cancer from forming.
Eliminating Doubt in Criminal Investigations
New ASU certificate to help curb error, misunderstanding in the quest for justice.
Determination of 13 Organic Toxicants in Human Blood
Researchers have utilised liquid-liquid extraction coupling HPLC-MS/MS to identify and quantify organic toxicants in human blood.
A Novel Cell Culture Model For Forensic Biology Experiments
Researchers have developed a new cell culture model which provides an efficient research tool in forensic biology.
Rhino DNA Bank Aids Anti-Poaching Fight
At the University of Pretoria's Veterinary Genetics Laboratory (VGL) at Onderstepoort, Dr Cindy Harper and her team have developed a ground-breaking technique to collect and catalogue DNA from rhinos and rhino horns.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!