First clinical trial for Hendra treatment in humans

Hendra virus
Hendra virus

The first clinical trial of a human monoclonal antibody therapy capable of neutralising the deadly Hendra virus is set to start early next year, it has been announced.

The treatment is not intended as a vaccine for the general population, but is expected to improve a person’s chance of survival should they come into contact with the virus.

The Hendra virus, first isolated in 1994, is a bat-borne virus capable of infecting horses, possibly through contact with bat urine, droppings, or birth materials. There have been seven confirmed cases in humans, all of whom caught it from infected horses. Four cases proved fatal.

Now, Queensland researchers are about to take a major step towards proving the safety of the only known effective treatment for preventing the disease in humans.

Queensland Health Minister Lawrence Springborg, New South Wales Primary Industries Minister Katrina Hodgkinson, and Queensland Agriculture Minister John McVeigh, have announced a $A1.2 million grant to fund a clinical trial of the antibody treatment.

“This world-first trial will test the monoclonal antibody in a small group of people for the first time to evaluate its safety, determine a safe dosage range and identify any side-effects,” Springborg said.

“There are many organisations involved in Hendra virus research and treatment as it’s a problem that knows no borders.

“This is a collaboration between groups in Queensland, New South Wales and the United States to develop a new medicine that could save lives in the event of a Hendra virus incident in Australia.”

Funding for the trial was drawn from $A9 million provided for Hendra virus research from the National Hendra Virus Research Program, to which the Queensland, New South Wales and Commonwealth governments each contributed $A3 million.

Hodgkinson said the clinical trial was a significant step forward in combating the virus. “This work is globally significant and, along with advancements in horse vaccine development, is critical in our future control strategies.”

The antibody for the trial was developed through a long-standing association between Queensland Health and the laboratories of Professor Christopher Broder of the US-based Uniformed Services University of the Health Sciences, and Dr Dimiter Dimitrov of the National Cancer Institute, also in the US.

They also worked with researchers at the Australian Institute for Bioengineering and Nanotechnology (AIBN) at the University of Queensland, and clinicians at Princess Alexandra Hospital in Brisbane.

AIBN’s director, Professor Peter Gray, said the monoclonal antibody to be used in the trial, known as m102.4, was classified as a biologic medicine and was manufactured at its National Biologics Facility using specialised cell factories developed by US collaborators, and a production process developed at AIBN.

“Biologics are medicines based on natural proteins made using recombinant DNA technology with the potential to target medical conditions for which there are no other treatments,” Gray said.

“It is important to understand that monoclonal antibody therapy is not a vaccine for the general population, but a treatment which is expected to improve a person’s chance of survival should they have come into contact with the Hendra virus.

“The Phase 1 clinical trial is planned for early 2014 upon approval from a Human Research Ethics Committee and in compliance with National Health and Medical Research Council guidelines.”

The trial results are expected to be known by the end of 2014.

“The United States is also interested in the results of the clinical trial as Hendra virus is similar to the Nipah virus which can cause death and severe illness in people and animals. Nipah virus is regularly found in humans in Bangladesh and India.”

News of the trial came just a day before first anniversary of the introduction of a vaccine for horses against Hendra. More than 150,000 doses have been administered in the first year.

Equivac HeV is said to provide at least six months of protection.

“The veterinary and equine industries have been critical to this encouraging spike in vaccination numbers,” said Dr Stephanie Armstrong from Zoetis, the company that developed the vaccine with the Commonwealth Scientific and Industrial Research Organisation (CSIRO).

“Veterinarians and leaders in the equine community have gone to great lengths to ensure that the public understand the role of the vaccine and the devastating impacts of a Hendra infection.”

CSIRO’s lead researcher in the development and testing of Equivac HeV, Dr Deborah Middleton, a veterinary pathologist, said she was pleased to see that the uptake of the vaccine has increased in the last five months.

“As a veterinarian, it is great to see how supportive the industry has been of Equivac HeV,” she said.

“I have seen first-hand how Hendra has created difficult working conditions for my colleagues and greater uptake of this vaccine will not only make their working lives easier, but it will also help protect them and their staff from a potentially fatal Hendra infection.”

Armstrong added: “While we have reached this important milestone, it is important that we continue to protect our horses against the virus. This disease doesn’t give any second chances, so it’s critical to take a preventative approach to protect veterinarians, their clients and the wider community in Australia.”

Among the doses administered, only 0.22 per cent of cases have reported minor adverse events, placing Equivac HeV in line with other vaccines on the market.

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