Listed clinical trials group Hvivo has been selected to carry out a human trial for a whooping cough vaccine in what is expected to be the largest such exercise it has ever conducted.
The company, formerly known as Open Orphan, has signed a letter of intent with Delaware-based group Iliad Biotechnologies to conduct a pivotal phase three human challenge trial for its lead Bordetella Pertussis vaccine candidate.
Iliad is a late-stage biotech development company, which has raised over $100 million to date. The group is focused on the prevention of whooping cough, a life-threatening disease caused by Bordetella Pertussis, which is a highly contagious respiratory bacterium.
The two groups are currently working to finalise the definitive agreement, and a further announcement will be made in due course.
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The landmark study would be the first phase three study to be conducted using a human challenge trial for Bordetella Pertussis.
A human challenge trial overcomes the difficulties associated with conducting traditional phase three field studies for whooping cough due to the unpredictability of outbreaks. The study is expected to commence in the second half of this year.
Whooping cough is particularly dangerous for babies under six months of age, causing serious and sometimes life-threatening complications. It affects about 16 million people globally, and accounts for about 160,700 deaths in children younger than age five years old annually. Although estimated global vaccination coverage is 84 per cent, current vaccines have failed to control epidemics.
Iliad chief executive Keith Rubin said the new vaccine has the “potential to address a major unmet medical need”, while Hvivo chief executive Yamin Mo Khan said he was pleased his company had been selected to carry out the trial.
“We have a long history of successfully conducting human challenge trials for our clients, which has supported our clients to bring life-saving medicine and vaccines to the global population,” he said.
“Conducting this large-scale phase three human challenge trial offers the potential to bring this leading vaccine to patients faster than would otherwise be possible.”
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