Aeras

Partnership objectives

  1. Develop new TB vaccines that are affordable and accessable to all those who need them
  2. Improvement of Bacille Calmette-Guérin (BCG) efficacy
  3. Development of an improved TB vaccine (as a booster for BCG and/or replacement of BCG)

It is the goal of Aeras to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 10 years. It is the goal of Aeras to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 10 years. Copyright Crucell

What are the health needs and challenges?

Many people think of tuberculosis as a disease of the past, but the reality is that TB is an urgent public health crisis. Each year, more than 8.5 million people become sick with TB and 1.3 million people die of the disease. In fact, TB is the leading cause of death among people living with HIV, causing one out of every four deaths. It is also the third leading cause of death for women, affecting people during their most productive years (ages 15-44).

While control programs are making progress in reducing deaths from TB, global TB incidence relative to population growth has remained consistently high. There are almost 1 million more cases of TB in the world today (8.6 million) than in 1990 (7.8 million). And because of growing drug resistance, TB is becoming much more difficult and expensive to treat.

Research and development for new vaccines would have the biggest impact on the epidemic, and remains the cornerstone to reaching global elimination within the coming decades.

Description of partnership activities and how they address needs and challenges:

The most effective way to stop the global TB epidemic is to prevent the spread of M. tuberculosis, but that is becoming increasingly difficult with the rise of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), the latter of which is resistant to most first- and second-line drugs. 

Aeras was founded in 1997 to develop new concepts and tools to control the global TB epidemic. It is the goal of Aeras to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 10 years.

GSK has long been committed to developing an effective tool against TB disease. For about 10 years, the company has been working with organizations such as Aeras in the development of a TB vaccine to ensure access to an effective TB vaccine to the populations who need it most. GSK’s current M72/AS01E candidate prophylactic vaccine has been tested in early stage Phase I/II studies in Europe and TB endemic countries.  In October 2012, GSK and Aeras entered into a new agreement with the goal of assessing the potential efficacy of the M72/AS01E candidate vaccine against TB disease and to investigate biomarkers of risk for TB disease and possible correlates of protection, which would benefit the TB vaccine field in general. The trial is targeted to start in summer 2014 and will enrol more than 3500 participants across several trial sites in South Africa, Zambia and Kenya. Information on the clinical trials is available online.

First-in-Human Clinical Trials:

First-in-human studies are small studies in healthy adults - usually 20-80 subjects - to evaluate the safety and immunogenicity of a vaccine candidate.

Phase I Clinical Trials:

Phase I clinical trials are small safety studies in different target populations. These may include a preliminary assessment of dose-range and/or age de-escalation.

Phase IIa Clinical Trials:

Phase IIa clinical trials are larger studies - usually 100-300 subjects - that explore dose-range in target populations with the goal of identifying the optimum dose; the dosing schedule; and/or the route of administration based on safety, immunogenicity and/or biological endpoints. These are focused studies designed to provide evidence of biological activity in the target population.

Phase IIb Clinical Trials:

Phase IIb clinical trials are larger, well-controlled studies that evaluate safety and proof-of-concept/efficacy. These trials usually include more than 1,000 subjects and are designed to demonstrate evidence of disease prevention or treatment in the target population.

Phase III Clinical Trials:

Phase III clinical trials are pivotal registration studies to support licensure. They are designed to demonstrate statistically significant evidence of disease prevention or treatment and long-term safety in target populations as required by national regulatory authorities. These studies are conducted with the final manufactured product.

Lessons learned:

South Africa is particularly poised as a key driver of TB vaccine innovation, since it has the highest incidence of the disease and is well-equipped with world-renowned researchers and infrastructure to conduct TB studies. Our in-country partners provide primary and follow-up care to communities involved in clinical trials. They educate the local communities and raise awareness about TB and vaccine trials.

Recently, the successful completion of the first large, Phase IIb trial in South Africa of nearly 3,000 infants showed that it is possible to conduct a trial of that scope and magnitude, even though the vaccine did not prove to be more efficacious than the widely used infant vaccine BCG.

Summary of impact and forward looking information

Serving as a critical translational bridge from the bench to the field Aeras has sponsored and conducted over 25 clinical vaccine trials enrolling thousands of subjects, and is a key partner in six active clinical development programs.

Videos

The Race Against Tuberculosis (Official Trailer)

Partnership information

Company(ies) GlaxoSmithKline , Johnson & Johnson , Sanofi

Partner(s) Australian Aid, Bill and Melinda Gates Foundation, CDC China, China National Biotec Group, European and Developing Countries Clinical Trials Partnership Programme (EDCTP), Global Health Innovative Technology (GHIT) Fund, Infectious Disease Research Institute (IDRI), International Maternal Pediatric Adolescent AIDS Clinical Trials Network, Organization of Educational Technology and Curriculum (OETC), Rijksoverheid, South African Tuberculosis Vaccine Initiative, Statens Serum Institute, Stop TB Partnership, Tuberculosis Vaccine Initiative, UK Department for International Development (DFID), University of Cape Town, US Food and Drug Administration (US FDA), US National Institutes of Health (NIH), Wellcome Trust

Type of Partner(s) Academia / Hospitals, Government, Multilaterals, NGOs, Other Business, PDPs

Therapeutic Focus Infectious Diseases

Disease(s) Tuberculosis

Program Type(s) Prevention Programs - Vaccines, Research & Development - Development of Treatments

Targeted Population(s) Children, General population, People with low income, Youth

Region(s) East Asia & Pacific, Europe & Central Asia, Middle East & North Africa, South Asia, Sub-Saharan Africa

Number of Countries 93

Country(ies) Afghanistan, Albania, Algeria, Angola, Armenia, Azerbaijan, Bangladesh, Belarus, Benin, Bhutan, Botswana, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, China, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Ghana, Guinea, Guinea-Bissau, India, Indonesia, Iran, Iraq, Israel, Jordan, Kenya, Kosovo, Lebanon, Lesotho, Liberia, Libya, Madagascar, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Moldova, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Niger, Nigeria, Pakistan, Philippines, Romania, Russia, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Singapore, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Swaziland, Syria, Tajikistan, Tanzania, Thailand, The Gambia, Togo, Tunisia, Turkey, Turkmenistan, Uganda, Uzbekistan, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Start Date 2004

More information Aeras

Anticipated completion date Ongoing