Leroy N. Soetoro
2013-05-04 04:43:18 UTC
http://www.latimes.com/health/la-sci-hiv-vaccine-trial-halted-
20130426,0,4809457.story
In another major setback for efforts to develop an HIV vaccine, federal
researchers have shut down a key clinical trial after an independent panel
of safety experts determined that volunteers who got an experimental
vaccine appeared to be slightly more likely to contract the human
immunodeficiency virus than those who got a placebo.
Investigators involved in recruiting volunteers and running the trial at
21 sites across the country were ordered Tuesday morning to stop
immunizing volunteers with the genetically engineered HVTN 505 vaccine and
to inform the nearly 2,500 people who participated in the study whether
they got the vaccine or the placebo. All of the volunteers were men or
transgender people who have sex with men.
The announcement came Thursday from the National Institute of Allergy and
Infectious Diseases, known as NIAID, which developed the HVTN 505 vaccine
and launched the advanced clinical trial in 2009. The vaccine was designed
to prime the immune system to mount a robust defense against all three
subtypes of the HIV virus.
Although earlier trials that tested the vaccine on fewer people suggested
it was able to produce an immune response to HIV and had a good safety
record, the larger trial revealed a "non-statistically significant
increase in HIV acquisition among volunteers in the investigational
vaccine group compared to those in the placebo group," NIAID said in a
statement.
The difference in infection risk between the vaccine group and the placebo
group could have been a matter of chance. Even so, the data failed to
indicate that the vaccine was having or would ever achieve its
intended effects of reducing one's risk of infection with HIV, the virus
that causes AIDS.
Also discouraging was the fact that the three-shot vaccine regimen did not
help suppress the replication of HIV in people once they were infected,
NIAID noted.
"This is quite a substantial disappointment," said Dr. Scott Hammer, a
Columbia University virologist who is one of the trial's principal
investigators. But, Hammer added, "we've learned from every clinical
efficacy trial we've done. We've had good and bad news, but each one takes
us a little closer in terms of what to pursue and not to pursue."
Altogether, there were 41 HIV infections among the 1,250 study volunteers
who got the experimental vaccine and 30 infections among the 1,244 who
received the placebo.
Of the 23 volunteers who became infected with HIV in the first 28 weeks of
the study, 14 had received the vaccine and nine had received the placebo.
The experimental vaccine was also a disappointment for another reason: It
failed to reduce the viral load of volunteers who became infected after
they enrolled in the trial.
In its statement, NIAID said that it "remains committed to the pursuit of
a highly effective, preventive HIV vaccine as part of a multifaceted HIV
prevention research program." Meanwhile, it said that study volunteers who
became infected during the trial would be referred to local services "for
appropriate care and treatment." The study's investigators would continue
to follow those volunteers for five years from the time they enrolled,
NIAID said.
This is not the first large HIV vaccine trial to end abruptly after
initial results proved disappointing. In 2003, early trials testing a
Genentech Inc. vaccine known as Aidsvax found that some who got it
developed HIV prompting government regulators to block further testing
in the United States. In 2007, a trial in South Africa that tested a
vaccine made by Merck & Co. was ended prematurely because participants who
got the active vaccine were found to have higher rates of infection than
those who did not.
The HVTN 505 vaccine regimen was an outgrowth of one of those
disappointments. Researchers improved upon the Aidsvax vaccine and tested
the new formulation, called RV-144, in heterosexuals in Thailand. In 2009,
they found that it reduced infection rates by 30%.
The HVTN 505 vaccine incorporated many of the lessons learned from the RV-
144 trial about constructing a vaccine that would train the immune system
to recognize and fight the genetic guts of the virus as well as its
"envelope," or outer cell wall.
That those lessons failed to yield a successful vaccine in the NIAID trial
was a bitter disappointment to researchers. In the coming weeks and
months, researchers will be poring over two years' worth of blood samples
from volunteers, said Dr. Stephen J. Brown, medical director of the AIDS
Research Alliance, the Los Angeles site participating in the HVTN 505
trial.
As they do so, Brown said, researchers are likely to glean new insights
into which parts of the current vaccine might form the basis for new HIV-
prevention regimens. The next HIV vaccine trials are to start next year in
southern Africa.
The World Health Organization estimates that 34 million people worldwide
are living with HIV, including 2.5 million who became infected in 2011 a
statistic that underscores the need for a vaccine. More than 25 million
people have died since the HIV/AIDS epidemic began, according to the WHO.
--
Barack Obama, reelected by the dumbest voters in the history of the United
States of America.
Eric Holder, racist black murdering United States Attorney General, still
has his job.
Nancy Pelosi, Democrat criminal, accessory before and after the fact to
improper vetting of Barry Soetoro aka Barack Hussein Obama, a confirmed
felon using SSAN 042-68-4425, belonging to a dead man.
Obama ignored the brutal killing of an American diplomat in Benghazi, then
relieved American military officers who attempted to prevent said murder
in order to cover up his own ineptness.
Obama continues his goal of disarming America while ObamaCare increases
insurance premiums 200% and leaves millions without health care.
Obama helped bankrupt Illinois. Democrat run Chicago closes 54 public
schools.
--- news://freenews.netfront.net/ - complaints: ***@netfront.net ---
20130426,0,4809457.story
In another major setback for efforts to develop an HIV vaccine, federal
researchers have shut down a key clinical trial after an independent panel
of safety experts determined that volunteers who got an experimental
vaccine appeared to be slightly more likely to contract the human
immunodeficiency virus than those who got a placebo.
Investigators involved in recruiting volunteers and running the trial at
21 sites across the country were ordered Tuesday morning to stop
immunizing volunteers with the genetically engineered HVTN 505 vaccine and
to inform the nearly 2,500 people who participated in the study whether
they got the vaccine or the placebo. All of the volunteers were men or
transgender people who have sex with men.
The announcement came Thursday from the National Institute of Allergy and
Infectious Diseases, known as NIAID, which developed the HVTN 505 vaccine
and launched the advanced clinical trial in 2009. The vaccine was designed
to prime the immune system to mount a robust defense against all three
subtypes of the HIV virus.
Although earlier trials that tested the vaccine on fewer people suggested
it was able to produce an immune response to HIV and had a good safety
record, the larger trial revealed a "non-statistically significant
increase in HIV acquisition among volunteers in the investigational
vaccine group compared to those in the placebo group," NIAID said in a
statement.
The difference in infection risk between the vaccine group and the placebo
group could have been a matter of chance. Even so, the data failed to
indicate that the vaccine was having or would ever achieve its
intended effects of reducing one's risk of infection with HIV, the virus
that causes AIDS.
Also discouraging was the fact that the three-shot vaccine regimen did not
help suppress the replication of HIV in people once they were infected,
NIAID noted.
"This is quite a substantial disappointment," said Dr. Scott Hammer, a
Columbia University virologist who is one of the trial's principal
investigators. But, Hammer added, "we've learned from every clinical
efficacy trial we've done. We've had good and bad news, but each one takes
us a little closer in terms of what to pursue and not to pursue."
Altogether, there were 41 HIV infections among the 1,250 study volunteers
who got the experimental vaccine and 30 infections among the 1,244 who
received the placebo.
Of the 23 volunteers who became infected with HIV in the first 28 weeks of
the study, 14 had received the vaccine and nine had received the placebo.
The experimental vaccine was also a disappointment for another reason: It
failed to reduce the viral load of volunteers who became infected after
they enrolled in the trial.
In its statement, NIAID said that it "remains committed to the pursuit of
a highly effective, preventive HIV vaccine as part of a multifaceted HIV
prevention research program." Meanwhile, it said that study volunteers who
became infected during the trial would be referred to local services "for
appropriate care and treatment." The study's investigators would continue
to follow those volunteers for five years from the time they enrolled,
NIAID said.
This is not the first large HIV vaccine trial to end abruptly after
initial results proved disappointing. In 2003, early trials testing a
Genentech Inc. vaccine known as Aidsvax found that some who got it
developed HIV prompting government regulators to block further testing
in the United States. In 2007, a trial in South Africa that tested a
vaccine made by Merck & Co. was ended prematurely because participants who
got the active vaccine were found to have higher rates of infection than
those who did not.
The HVTN 505 vaccine regimen was an outgrowth of one of those
disappointments. Researchers improved upon the Aidsvax vaccine and tested
the new formulation, called RV-144, in heterosexuals in Thailand. In 2009,
they found that it reduced infection rates by 30%.
The HVTN 505 vaccine incorporated many of the lessons learned from the RV-
144 trial about constructing a vaccine that would train the immune system
to recognize and fight the genetic guts of the virus as well as its
"envelope," or outer cell wall.
That those lessons failed to yield a successful vaccine in the NIAID trial
was a bitter disappointment to researchers. In the coming weeks and
months, researchers will be poring over two years' worth of blood samples
from volunteers, said Dr. Stephen J. Brown, medical director of the AIDS
Research Alliance, the Los Angeles site participating in the HVTN 505
trial.
As they do so, Brown said, researchers are likely to glean new insights
into which parts of the current vaccine might form the basis for new HIV-
prevention regimens. The next HIV vaccine trials are to start next year in
southern Africa.
The World Health Organization estimates that 34 million people worldwide
are living with HIV, including 2.5 million who became infected in 2011 a
statistic that underscores the need for a vaccine. More than 25 million
people have died since the HIV/AIDS epidemic began, according to the WHO.
--
Barack Obama, reelected by the dumbest voters in the history of the United
States of America.
Eric Holder, racist black murdering United States Attorney General, still
has his job.
Nancy Pelosi, Democrat criminal, accessory before and after the fact to
improper vetting of Barry Soetoro aka Barack Hussein Obama, a confirmed
felon using SSAN 042-68-4425, belonging to a dead man.
Obama ignored the brutal killing of an American diplomat in Benghazi, then
relieved American military officers who attempted to prevent said murder
in order to cover up his own ineptness.
Obama continues his goal of disarming America while ObamaCare increases
insurance premiums 200% and leaves millions without health care.
Obama helped bankrupt Illinois. Democrat run Chicago closes 54 public
schools.
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