Experimental hepatitis C vaccine shows early promise

LONDON Wed Jan 4, 2012 2:08pm EST

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LONDON (Reuters) - A new vaccine against the chronic liver disease hepatitis C has shown promising results in an early-stage clinical trial in humans, British and Italian scientists said Wednesday.

They said the experimental vaccine, which is based on a modified cold virus and was safety-tested in 41 people, generated immune responses similar to those seen in people who have a rare but natural defense against the disease.

The results suggest it might be possible in future to develop a potentially long-lasting vaccine that would be broadly effective against hepatitis C - a virus estimated to infect around 170 million people worldwide.

But the researchers, whose findings were published in the Science Translational Medicine journal Wednesday, cautioned that much more research is needed over many years before a successful vaccine could be fully developed.

"We've found that it's possible to prime large cellular immune responses against hepatitis C that last for at least a year," said Paul Klenerman of Britain's Oxford University, who led the first trials of the vaccine in humans.

"The immune responses we've seen are exciting and we are beginning the next stage of trials," he said in a statement about the results, adding: "It could be a long road."

Hepatitis C is caused by a virus transmitted through the blood. Those infected can have it for years without symptoms, but if left untreated it can lead to cirrhosis, liver cancer and death.

The mainstay of hepatitis C treatment has been a combination of the generic medicines interferon and ribavirin, but they have only around a 50 percent success rate and interferon can cause flu-like symptoms that mean many patients stop their treatment.

New drugs, including Incivek from Vertex Pharmaceuticals and Merck's Victrelis, were licensed in 2011 and are proving popular, but they still need to be taken with interferon and ribavirin.

Because hepatitis C is a virus that constantly changes, it is a tricky target for designing a vaccine and no successful shot against the infection has yet been developed. There are also six different strains of the virus, making it difficult to make vaccine that works for all types.

The team worked with researchers from Britain's Birmingham University and from Okairos, a small Italian biotech firm, on a new approach to developing a vaccine by stimulating a different part of the immune system from those tried before.

The new vaccine, the researchers explained, is designed to generate a response in the immune system's T-cells to the internal parts of the virus, which are more constant, rather than trying to prime an antibody attack on the virus's ever-changing outer coat.

"The outside shell of the hepatitis C virus is very variable but the inside of the virus is much more stable. That's where the engine of the virus is, where we may be able to successfully target many of the crucial pieces of machinery," said Klenerman.

The team tested the vaccine in a so-called Phase I study designed primarily to gauge the vaccine's safety. A total of 41 healthy adults took part in the study and results showed the vaccine appeared safe and was able to stimulate a large T-cell response against hepatitis C that lasted for at least a year.

The Oxford researchers are starting trials to see if the vaccine can help treat people already infected with hepatitis C, as well as continuing to develop the vaccine to get better immune responses.

"T-cell responses often become weak in those with chronic hepatitis C infections," Klenerman said. "It may be that using a vaccine to boost their immunity could become part of any treatment with other drugs."

A separate research team in the United States is also planning a larger trial in at-risk groups to see if the vaccine can protect against hepatitis C infection, he said.

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