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On-farm Trials For Bovine TB Vaccine Move On To Next Phase

On-farm trials for a cattle vaccine and new skin test for bovine TB are set to move to the next phase, government vets have announced.

Farmers and veterinarians are now being encouraged to volunteer and support the delivery of the Animal and Plant Health Agency (APHA) project.

The next phase of the field trials, similarly to the previous two phases, will take place on commercial cattle farms in areas of England and Wales.

The trials will commence on farms where there is a low incidence of bTB, and are set to be completed in 2026-2027.

Development of a cattle vaccine against bovine TB is at the forefront of global solutions to help eradicate this disease.

Over 60,000 cattle in England and Wales were slaughtered during 2023-2024 to tackle bovine TB.

If the next phase is successful, the UK would take a step closer to a vaccine which would be used in conjunction with other measures to tackle the disease.

Laboratory studies have indicated that the CattleBCG vaccine and DIVA skin tests are safe and that the test performs well, under controlled APHA facility environments.

When coupled with the skin test, APHA said the vaccine represented a 'significant advancement' in bTB control that could contribute to reducing the disease in cattle, APHA said.

Previous studies with vaccinated animals have demonstrated significant protection against experimental challenge with high dose of bTB.

UK chief veterinary officer, Christine Middlemiss said: "bTB has remained one of the most difficult animal disease challenges to tackle, causing devastation to farmers and rural communities.

"These trials and the active participation of farmers will help us in ensuring any new vaccine and testing approach is both effective and practical."

Jenny Stewart, APHA chief executive, said the launch of the next phase of trials marked a significant step forward in developing a viable and effective TB vaccine.

"APHA scientists and field colleagues are at the forefront of tackling animal and plant disease outbreaks and this new phase will further our understanding of this disease.

"If you have a cattle herd that meets the inclusion criteria and are interested in taking part, please do contact us to be a part of this research."

Farmers interested in taking part can contact APHA by emailing tb.Advice@apha.Gov.Uk.

TB Vaccine And Test Move To Next Phase In England And Wales

Commercial cattle farms in low-incidence bovine tuberculosis (TB) areas of England and Wales are being invited to participate in the next round of field trials for a cattle vaccine and new skin test.

The Animal and Plant Health Agency (Apha) is looking for interested farmers and vets, who are being encouraged to volunteer and support the delivery of the project as it moves into Phase 3 trials.

See also: Experts to review new evidence in battle against bovine TB

To be eligible, herds must be officially TB Free (OTF), from the Low-Risk Area (LRA) of England or the Low TB Area (LTBA) of Wales, and have been in existence for eight years or more.

They must not currently be in an enhanced surveillance testing regime, such as radial or contiguous TB testing, and not be in an active TB hotspot (as defined by Apha).

Cattle herds must also have been OTF for a minimum of three continuous years with a herd tuberculin skin test completed within three calendar years, and not have introduced cattle from a higher TB risk area in the 12 months prior to the enrolment date.

Bovine TB costs taxpayers in England about £100m every year, with an estimated further £50m cost to the industry. More than 60,000 cattle in England and Wales were slaughtered during 2023-24 to tackle the disease.

© Tim Scrivener

Apha is confident that if this next phase is successful, the industry will be a step closer to a vaccine which can be used in conjunction with other measures to tackle the disease.

UK chief veterinary officer Christine Middlemiss said: "These trials and the active participation of farmers will help us in ensuring any new vaccine and testing approach is both effective and practical."

Laboratory studies have indicated that both the cattle BCG vaccine and Diva (detecting infected among vaccinated animals) skin test are safe and the test performs well under controlled Apha facility environments.

Recent international studies investigating the full extent of BCG protection in natural conditions found a total efficacy of 89%.

Apha chief executive Jenny Stewart said this round of field trials was a significant step forward in developing a viable and effective cattle TB vaccine, and urged those who meet the criteria to contact Apha if they are interested in participating.

Further information on the field trials can be found on the TB Hub.

IAVI And Biofabri Dose First Adults And Teens In TB Vaccine Trial

International non-profit research company IAVI has dosed the first patients in its Phase IIb trial of tuberculosis (TB) vaccine, which, if approved, could be the second to be cleared in more than 100 years.

Alongside Spanish biopharmaceutical company Biofabri, the randomised placebo-controlled IMAGINE trial examining MTBVAC (NCT06272812) will recruit approximately 4,300 adolescent and adult patients with latent TB infection, shown by a positive interferon gamma release assay (IGRA) test, across 15 sites in South Africa, Kenya, and Tanzania.

The current standard of care for TB has remained unchanged since the invention of the first vaccine, Bacillus Calmette-Guérin (BCG), in 1921. This vaccine is thought to last approximately 20 years and doesn't offer complete protection into adolescence and adulthood. This vaccine was originally derived from the bovine version of the disease, mycobacterium bovis. In contrast, MTBVAC is a live-attenuated TB vaccine candidate derived from mycobacterium tuberculosis.

A previous Phase II study (NCT03536117) examined the vaccine in newborns, with Biofabri now conducting a Phase III trial of the vaccine in neonates in South Africa, Madagascar, and Senegal.

A separate study, published in Nature, found MTBVAC in adult rhesus macaques showed a significant improvement following aerosol exposure to M. Tuberculosis compared to a single BCG vaccine.

Lewis Schrager, head of IAVI's TB vaccine development group, said: "The IMAGINE trial is an important new effort to develop a vaccine capable of combatting the world's deadliest disease. Because MTBVAC is a single-shot vaccine we are hopeful that, if proven effective, MTBVAC could prevent millions of cases of TB disease, particularly in persons living in some of the world's most difficult-to-reach locations."

The vaccine was initially designed by researchers at the University of Zaragoza alongside the Institut Pasteur and is now developed and licensed by Biofabri. Funding for the trials was provided by Open Philanthropy, the Bill and Melinda Gates Foundation, and the German Federal Ministry of Education and Research.

Research by the World Health Organization (WHO) estimates that 1.25 million people died as a result of TB in 2023 alone. It is currently considered to be one of the world's leading causes of death from a single infectious agent and a driver of anti-microbial resistance. Under the right circumstances, TB can become zoonotic, meaning it can spread between species.

Keertan Dheda, principal investigator for the trial, said: "An effective vaccine is urgently needed for TB, historically the biggest killer of mankind, which results in 11 million newly diseased individuals every year.

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"Besides the millions of resultant deaths, TB is also associated with substantial reductions in the gross domestic product of low- and middle-income countries, given that economically active young people are often affected by the disease."

Experts have raised concerns about TB research as some funding comes from the US Agency for International Development (USAID), which has recently been stopped. Experts have said that sponsors, agencies or foundations may have to fill funding gaps to ensure vital research continues.

Elsewhere in the treatment of TB, Medical AI company Lunit's chest X-ray analysis software INSIGHT CXR has demonstrated superior performance in TB detection.

"IAVI and Biofabri dose first adults and teens in TB vaccine trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

 

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