Upcoming TB vaccine looks promising MVA85A/AERAS-485

MVA85A/AERAS-485 vaccine has been awarded orphan drug status by the European Medicines Agency (EMEA) and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.

The new vaccine – MVA85A/AERAS-485 – is considered the most exciting advance in the field of TB vaccines for over 80 years.

MVA85A/AERAS-485 – promising vaccine for tuberculosis – is passing through a crucial phase of development in Cape Town, South Africa.

MVA85A/AERAS-485 is developed at the University of Oxford.

The  MVA85A/AERAS-485 vaccine candidate will be put to Phase IIb proof-of-concept trials in South Africa by the Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd.  Isis Innovation Ltd., the Wellcome Trust and the University of Cape Town (UCT).

The MVA85A/AERAS-485 vaccine study will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) of UCT in the Western Cape Region from its study site 100 km from Cape Town in Worcester, South Africa.

This study will test MVA85A/AERAS-485 in approximately 2,784 children under one year of age, all of whom have received Bacille Calmette-Guerin (BCG) at birth.

MVA85A/AERAS-485 human studies have been approved by the Medicines Control Council of South Africa – the country’s drug regulatory authority.

MVA85A/AERAS-485 vaccine has been awarded orphan drug status by the European Medicines Agency (EMEA) and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.

“We believe this is the most exciting advance in the field of TB vaccines for over 80 years,” said Dr Helen McShane of the Jenner Institute, University of Oxford, “and is a testament to the commitment shown by the partners and funders involved. We have shown that this vaccine is safe and stimulates strong immune responses. This trial will hopefully show that the vaccine can protect people from getting TB and enable the global community to begin to control this devastating disease.”

The Phase 2b studies will evaluate MVA85A/AERAS-485 vaccine candidate’s  safety, immunogenicity and preliminary efficacy.

This is the first proof-of-concept trial of a new preventive TB vaccine in infants in more than 80 years.

MVA85A/AERAS-485 vaccine is being tested in an area burdened by one of the highest incidence rates of TB in the world, in a community most likely to benefit from its success, according to the partners.

Approximately one out of every three people on the planet is affected with tuberculosis or TB. TB kills 1.8 million people per year and more than two billion people worldwide are infected with TB.

BCG is currently the only available vaccine against TB. BCG, which is administered to infants throughout the developing world and in certain countries in the developed world, provides some protection against pediatric TB. However, BCG provides only variable protection against pulmonary tuberculosis, which accounts for most of the worldwide disease burden.

“The world desperately needs new and better approaches to combat TB,” said Dr. Marcos Espinal, executive secretary of the Stop TB Partnership. “The advancement of a new TB vaccine candidate to this stage is an exciting development for all of us who seek to end this terrible epidemic.”

MVA85A/AERAS-485 vaccine candidate is intended to boost the response of T-cells already stimulated by the BCG vaccine given in the childhood.

Previous clinical trials of MVA85A/AERAS-485 vaccine in adults have demonstrated consistently high cellular immune responses in those who received the MVA85A/AERAS-485 vaccine candidate following vaccination with BCG.

“There is still a long road ahead, but this marks an important milestone toward the goal of a more effective TB vaccine,” said Jerald C Sadoff, MD, president & CEO of the Aeras Global TB Vaccine Foundation.

The Aeras Global TB Vaccine Foundation is working with the Consortium to develop MVA85A/AERAS-485 with additional funding from the Wellcome Trust.

MVA85A/AERAS-485  vaccine candidate 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.

MVA85A/AERAS-485 vaccine was licensed by Isis Innovation, the University’s technology transfer company to the Oxford-Emergent TB Consortium in July 2008.

“This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world’s deadliest diseases,” said Fuad El-Hibri, chairman and chief executive officer at emergent BioSolutions.

The Aeras Global TB Vaccine Foundation is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines. Aeras’ major funders are the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs, the Danish International Development Agency, the Research Council of Norway and the U.S. Centers for Disease Control and Prevention. Aeras operates a state-of-the-art manufacturing and laboratory facility in Rockville, Maryland, USA.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics. Emergent’s marketed product, BioThrax (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programmes focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia.

Isis Innovation Ltd is the University of Oxford’s technology company and manages the University’s intellectual property portfolio, working with University researchers on identifying, protecting and marketing technologies through licensing, spin-out company formation and material sales. Isis files on average one new patent application each week, has concluded over 400 technology licensing agreements, and established 62 new spin-out companies from Oxford.

The Oxford-Emergent Tuberculosis Consortium Ltd “OETC” is a joint venture between the University of Oxford and Emergent Product Development UK Ltd. OETC was formed with the aim of developing the MVA85A TB vaccine to meet both developed and developing country health needs.

The South African Tuberculosis Vaccine Initiative is located in the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (UCT).

The University of Oxford’s Medical Sciences Division is one of the largest biomedical research centers in Europe.

Wellcome Trust is the largest charity in the UK.