Corporate Banner
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
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 2,500+ scientific posters on ePosters
  • More Than 3,800+ 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

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
Study Reveals Extent of Type 2 Diabetes Problem in Black and Minority Ethnic Populations
According to the study half of all people of South Asian, African and African-Caribbean descent will develop diabetes by age 80.
Friday, September 14, 2012
£30 Million Boost for Biomedical Engineering Research
Partnership will provide funding for long-term projects that address healthcare needs.
Wednesday, September 12, 2012
Wellcome Trust and MRC Invest in World-Class Stem Cell Institute
Two of the UK’s largest funders of medical research are to invest £8 million in a new world-leading centre for stem cell biology and medicine.
Thursday, August 09, 2012
Scientific News
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
Low-level Arsenic Exposure Before Birth Associated with Early Puberty in Female Mice
Study examine whether low-dose arsenic exposure could have similar health outcomes in humans.
Inciting an Immune Attack On Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Intensity of Desert Storms May Affect Ocean Phytoplankton
MIT study finds phytoplankton are extremely sensitive to changing levels of desert dust.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!