For some people, the flu can just be an inconvenience--feeling rotten and perhaps a week off work. However, for elderly people, it can lead to hospitalization, long-term complications and, in some cases, it can even be fatal. But data from a Phase II trial of a universal influenza vaccine show not only that the candidate is effective in elderly people, but also that it boosts the effects of other flu vaccines.
Israeli company BiondVax's universal influenza vaccine, known as Multimeric-001, was well tolerated in a group of 120 volunteers aged 65 and over, and the shot triggered immune responses in this group when used alone. When it was given as a primer shot, before a booster shot of a standard seasonal trivalent inactivated flu vaccine, Multimeric-001 improved the immune response from the standard vaccine, the company reports. This is significant because around 60% of elderly people do not have a high enough immune response to the standard vaccine to be protected. While BiondVax has already released results from its first Phase II trial, the company believes this is the first Phase II study of a universal flu vaccine in elderly people.
Multimeric-001 is labeled 'universal' because it is based on peptides that are common to the majority of existing strains of flu, including the avian and swine varieties. Because these peptides change very little, the company expects the vaccine to cover future strains of the virus as it mutates.
"We are delighted with these Phase II results," Dr. Ron Babecoff, BiondVax's CEO, said in a statement. "We have confirmed, in what is to our knowledge, the first Phase II study of a universal flu vaccine in elderly, that the Multimeric-001 vaccine is not only safe and immunogenic on its own but also enhances the performance of traditional strain-dependent flu vaccines in the elderly when given in a prime-boost regimen. We are excited to report that this prime-boost indication for our universal flu vaccine increased immunity to trivalent inactivated vaccine flu strains by more than 10 percent."
The company has not published these results, but they will be reported at the 2nd Annual Vaccines Congress in London, as well as at the World Vaccine Congress in Washington D.C., so any conclusions drawn have not yet been peer-reviewed. BiondVax is planning a third Phase II trial in the elderly in Europe in the 2012/2013 flu season, and the company expects to begin Phase III trials later in 2013, according to its website.
- read the press release