News agency, Cape Town, South Africa
Tuesday September 18th 2018

Boland TB vaccine trial results provide hope

04.02.2013

A groundbreaking Tuberculosis inoculation trial in the Boland region is providing hope for the further development of an effective TB vaccine for children.

TB was one of the highest killer diseases in South Africa and finding an efficient replacement for the commonly used Bacillus Calmette-Guerin was an urgent matter.

According to the World Health Organisation (WHO), about 100 million newly born babies were being vaccinated using BCG each year and while this vaccine could prevent severe forms of TB in some children, its widespread use in infants had failed to control the global epidemic.

But positive results from a three-year study sponsored by the non-project biotech organization Aeras and University of Cape Town’s South African Tuberculosis Vacccine Initiative (SATVI) to investigate the safety and efficacy of MVA85 vaccine in BCG-vaccinated children, were released today.

Funding for the clinical trial was provided by Aeras, the Wellcome Trust and the Oxford Emergent Tuberculosis Consortium.

MVA85 is said to be the first “novel” preventive TB vaccine after BCG to complete a phase 2b safety and efficacy study.

MVA85’s ability to prevent TB infection was tested in 2 800 infants who had tested negative for TB and HIV and had all initially received BCG at birth.

Half of those infants, aged between four and six months, then received a single dose of MVA85A while the other half received a placebo.

The researchers today said while MVA85 had failed to prevent TB, it was “generally well tolerated” and had a “safety profile” comparable to other pediatric vaccines.

The most frequent side effect observed was “mild redness or swelling around the injection site following vaccination”.

With the test vaccine’s safety established, further tests could be conducted.

Commenting on the results of the study, principal researcher for the study, Dr. Mechelle Tameris from UCT said “it was early days” highlighting that they would study the outcome in depth and see what changes they could make in a bid create an effective vaccine.

Professor Helen McShane, Wellcome clinical research fellow at Oxford, concurred, saying 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.”

She said 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.”

Professor Willem Hanekom director at SATVI said they were proud “ to have completed the first efficacy trial of a new TB vaccine in 90 years”.

She believed the results would guide the TB vaccine field in the future highlighting that said the “TB epidemic in our country is devastating – half a million South Africans develop the disease every year.

“Prevention by an effective vaccine would be the best way to get the epidemic under control.

“With this goal in mind, our group will continue to test multiple new vaccine candidates in the Worcester area. We are very grateful for the commitment of the local community in this effort,” she said. – Francis Hweshe

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