Health authorities in Australia have been granted approval for human trials of a laboratory-produced monoclonal antibody designed for treating those exposed to the dangerous Hendra virus.
The trial, involving volunteers, will be conducted this year. Healthy men and women aged 18 to 50 are being sought for the study, with some already having come forward.
The approval, granted to Queensland’s Department of Health, follows the announcement in late 2013 of a $A1.2 million state and federal grant to fund a human clinical safety trial.
The trial will be run at the QIMR Berghofer Medical Research Institute and will be supervised by Hendra virus specialist Dr Geoffrey Playford, from the Princess Alexandra Hospital.
“The human monoclonal antibody m102.4 was developed for the treatment of Hendra virus infection in people,” Playford explains.
“To date, the antibody has only ever been used on compassionate grounds in eleven people. Of these patients, 10 survived but there was insufficient information to determine whether the use of the monoclonal antibody influenced this outcome, which is why further research is required.”
A monoclonal antibody is a laboratory-produced molecule that is carefully engineered to attach to specific defects in a targeted cell – in this case a Hendra virus cell.
Playford said monoclonal antibodies mimicked the antibodies the human body naturally produced as part of the immune system’s response to germs, vaccines and other invaders.
“The antibody is designed to attach to part of the Hendra virus, thereby alerting the body’s immune system to the virus’s presence and marking it for destruction,” he said.
“The main objective of the study is to evaluate the safety and tolerability of the Hendra virus monoclonal antibody m102.4.
“Basically, we want to find out how the antibody makes people feel and whether there are any side effects. The trial will also determine the amount of antibody in a person’s blood at various times during the study and the effect it has on the immune system.”
Queensland’s chief health officer, Dr Jeannette Young, said testing the monoclonal antibody on humans would see the state move one step closer to protecting those at high risk of developing Hendra virus following contact with an infected horse.
The director of the University of Queensland’s Australian Institute for Bioengineering and Nanotechnology (AIBN), Professor Peter Gray, said the trial’s journey began in 2010 when the state’s chief health officer obtained a licence from the US Department of Defence, to produce the experimental antibody called m102.4.
“Our experts at UQ’s AIBN have worked very hard to produce the m102.4 monoclonal antibody. It’s now exciting to think that, with human trials being approved in compliance with international guidelines, we are that much closer to saving infected people’s lives,” Gray said.
Since 1994, there have been 52 incidents of Hendra virus in horses in Australia, with 14 in New South Wales and 38 in Queensland. A total of 90 horses have died from the Hendra virus during this period. There have been seven cases of Hendra Virus infection in humans, resulting in four deaths.
All cases of human infection, believed to result from contact with the bodily fluids of infected horses, have occurred in Queensland.
More information: http://www.hendrastudy.com.au