Completed Infection & Immunity Pregnancy, Children & Inherited Conditions

A proof of concept Phase IIb efficacy trial to evaluate the protective efficacy of a booster MVA85A vaccination administered to BCG primed infants in the Western Cape.

Funder Wellcome Charity-funded
Recipient organisation University of Oxford
Funding £4.0M
Period Jan 2008 — Aug 2014

In plain English

AI plain-English summary

A single shot of a new TB vaccine, MVA85A, is being tested in South African infants to see if it can actually prevent the disease. Tuberculosis kills more people than any other infectious disease, and the only existing vaccine, BCG, provides inconsistent protection—especially against the lung form of TB that spreads between people. MVA85A is designed to boost BCG’s effects. It has already passed safety and immune-response tests in adults and infants in the UK and The Gambia, and in South African adults and adolescents. The critical missing piece is proof that it works. If this trial shows that MVA85A protects infants, it would be the first new TB vaccine to demonstrate efficacy in decades. That could change how TB is controlled in high-burden countries, reducing transmission and saving lives. Even a partially effective booster would be a major step forward for global public health. This is a direct test of a practical intervention, not fundamental science—the question is simply whether the vaccine prevents disease in the real world.

View original technical description
MVA85A is a recombinant modified vaccina virus Ankara (MVA) expressing an immunodominant antigen (antigen 85A) from Mycobacterium tuberculosis (M.tb). MV85A is a leading new TB vaccine developed to boost BGC. The efficacy of a BGC prime - MVA85A boost vaccination regimen has been demonstrated in 3 preclinical models; mice, guinea pigs and non-human primates. Clinical trials with MVA85A show that it is safe and highly immunogenic in all populations tested to date. These include: subjects latently infected with M.tb and subjects infected with HIV in the UK; and adults and infants in The Gambia. Detailed immunological analysis demonstrated that the vaccine induces highly polyfunctional antigen-specific T cells containing IL2, TNFa and IFN-y. These cells proliferate and have a non-terminally differentiated phenotype. We are currently conducting a series of Phase IIa clinical trials in South African and have shown that the vaccine is safe and highly immunogenic in South African adults and adolescents. Trails are underway in HIV/TB infected adults and are due to start in children and infants. The key question is whether this highly immunogenic and safe vaccine is protective, and therefore the next step is to evaluate the protective efficacy of MVA85A in a Phase IIb proof-of-concept study in South African infants.

View the original record at the funder ↗

Researchers

Helen McShane (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

MVA85A Tuberculosis Vaccine Prime and Selective Delayed BCG Boost in Infants of HIV Infected Mothers
MVA85A Tuberculosis Vaccine Prime and Selective Delayed BCG Boost in Infants of HIV Infected Mothers.
Characterising the immune response to antigen 85A of non-tuberculous mycobacteria in Cape Town and Oxford.
A clinical study comparing the immune response to revaccination with intradermal BCG and aerosol BCG in previously BCG vaccinated healthy adult volunteers with and without Type 2 Diabetes
Evaluating a multi-valent aerosol booster tb vaccine for adolescents and young adults in diverse african settings: T5 tbvac

Original classification

Strategic Award - Innovations

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.