Published: 3:06AM Wednesday October 21, 2009
Source: Reuters
Source: ONE News
Doctors who surprised the world of AIDS research with a study
showing a vaccine prevented some HIV infections released details of
their findings and said careful review showed they held up.
Full details of the study, which showed the experimental vaccine
prevented nearly one-third of infections among 16,000 ordinary Thai
volunteers, were published in the New England Journal of
Medicine.
"That's a validation of the results," said Jerome Kim, a US Army
colonel at the Walter Reed Army Institute of Research in Maryland,
who helped lead the trial.
The vaccine is a combination of Sanofi-Pasteur's ALVAC canary
pox/HIV vaccine and the failed HIV vaccine AIDSVAX, made by a San
Francisco company called VaxGen and now owned by the non-profit
Global Solutions for Infectious Diseases.
The trial, sponsored by the US government and the Thai Ministry of
Public Health, cut the risk of infection by 31.2% over three years,
according to one analysis of the data.
Kim's team said the effect was modest and hard to interpret, that
the vaccine was not nearly ready for commercial use and might not
work in Africa, where AIDS is most common.
What worked might have been the combination of both drugs, and not
one or the other, Kim told a news conference in Paris on Tuesday
after he and colleagues presented the findings to a meeting of AIDS
vaccine researchers.
"The combination in the vaccine generated slightly different and
slightly more potent response than each individual component alone,
we don't know that that's the case here, but it's something we'd
like to investigate."
Days after the results were announced at an unusual news conference
in Bangkok in September, some unidentified researchers were quoted
by Science magazine and The Wall Street Journal as saying the study
was weaker than at first presented.
Different analyses
At issue were the statistical methods used to analyse the
data.
Kim's team conducted three different analyses - one called an
intention to treat analysis, one called a modified intention to
treat analysis and one called a pro-protocol analysis.
Those who questioned the findings, according to media reports, said
two of the methods were statistically insignificant.
In a commentary in the journal, Raphael Dolin of Beth Israel
Deaconess Medical Center and Harvard Medical School in Boston said
the study had been rigorously designed and conducted.
"Although the merits of each type of analysis can be debated, all
three yielded a possible, albeit modest, effect of the vaccine in
preventing HIV infection," Dolin wrote.
What is still unclear was how long the protection lasts and how
much each of the two vaccines contributed.
"The most important thing all of us are interested in is why from a
scientific standpoint we saw the results that we saw," US Army
Colonel Nelson Michael said.
The AIDS virus infects an estimated 33 million people globally and
has killed 25 million since it was identified in the 1980s.
Cocktails of drugs can control HIV but there is no cure.
In 2007, Merck & Co ended a trial of its vaccine after it
was found not to work, and in 2003, AIDSVAX used alone was found to
offer no protection, either.
Supachai Rerks-Ngarm, a disease control expert from Thailand's
Health Ministry, said more work would need to be done with trial
participants.
"We have to explain what made the vaccine work, and how we can make
it work better for future improvement of vaccine candidates," he
said.
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