Please login to the form below

Not currently logged in

GSK squares up to Merck with shingles vaccine data

Trial shows vaccine cut the risk of shingles in over 50s by 97%

GSK - logo on building 

GlaxoSmithKline (GSK) has reported positive phase III trial data for a new shingles vaccine that could be the first major competitor to Merck & Co's Zostavax.

Shingles, also known as herpes zoster, is a painful skin rash caused by the reactivation of the chickenpox virus in people who have previously had the illness.

It can be extremely painful and in some cases leads to long-term pain (post-herpetic neuralgia) that does not resolve after the skin lesions have healed and can last for years.

The HZ/su vaccine cut the risk of shingles developing in people aged over 50 by 97% compared to placebo in the 16,000-patient ZOE-50 study, which got underway in 2010. In trials, Zostavax' protective efficacy was around 70%, although there are no direct head-to-head comparisons of the two vaccines.

The vaccine - which has been predicted to become a $1bn-a-year product if approved - is administered in two doses two months apart by intramuscular injection, while Zostavax is given in a single shot. GSK's vaccine is based on a protein called gE found on the herpes zoster virus, while Zostavaz is a live, attenuated form of the zoster virus.

Merck reported Zostavax sales of $758m in 2013, a 16% increase on the prior year as take-up in elderly patients continues to grow thanks to a new direct-to-consumer (DTC) advertising campaign.

HZ/su also includes Agenus' AS01B adjuvant, which was also used in the company's RTS vaccine for malaria and MAGE-A3 vaccine, which flunked trials in melanoma and lung cancer. Shares in Agenus climbed more than 17% on the news

"If approved, this candidate vaccine may offer an important option for the prevention of shingles, a painful disease that negatively impacts peoples' health and quality of life," said Alain Brecx, vaccine development leader at GSK.

The company said the safety data from the trial would be analyst by its independent data monitoring committee over the coming months, but as of the last review at the end of May no serious side effects had been identified.

GSK has not indicated when it hopes to file for approval of HZ/su, but said it currently has other studies ongoing to test the vaccine's safety and efficacy in people aged 70 and older and in immunocompromised people and will be reporting additional clinical data in 2015. 

Article by
Phil Taylor

22nd December 2014

From: Research



Featured jobs

Subscribe to our email news alerts


Add my company
Create Health

A healthcare marketing agency that shares your passion for making things better. Our clients with solve real health problems every...

Latest intelligence

Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...