The first phase of a clinical trial on a vaccine designed to combat the avian flu virus is expected to conclude Oct. 31, as officials begin building a defense against a potentially deadly pandemic.
Experts at the University of Maryland Medical Center in Baltimore were asked to determine what would be optimal and safe dosages of a vaccine produced by pharmaceutical company sanofi pasteur to ensure a person was properly protected from the avian influenza virus H5N1, the deadly form that’s surfaced in Europe and Asia.
Sanofi pasteur provided researchers with 8,000 trial doses of the vaccine that was specifically designed to fight H5N1 avian flu virus, company spokesman John Abrams said.
James Campbell, the principal investigator for the study and assistant professor of pediatrics, said he and his collaborators at the University of Rochester and the University of California in Los Angeles determined that the vaccine should be administered in two doses.
“A single dose of the vaccine did not give people protective levels of antibodies in their blood,” he said.
Four different dose amounts were tested: 7.5, 15, 45 and 90 micrograms, Campbell said. The scientists found that the two largest amounts produced the most significant immune response.
The vaccine appears to be safe, Campbell said, adding that the 154 Maryland volunteers were monitored for red or sore arms or other adverse reactions to the intravenous shots.
“Still, whenever you test a new vaccine, you have to start with the assumption that there might be something that you weren’t expecting but could happen,” he said.
On Oct. 31, the scientists will draw new blood samples from the Maryland volunteers and take a last measure of antibodies in their blood. Those results will be compared to blood drawn before the first vaccine was administered and at two other stages during the study.
Antibodies are what the immune system makes to fight a foreign invader or disease, Campbell said. More antibodies detected in the blood means that the body is developing a better immune response to fight the avian flu.
Campbell said he didn’t know when, or whether, the vaccine would make it to the market.
“At this point, it’s hard to predict, but if the need arose, doses will be made,” he said.
&nb
Experts at the University of Maryland Medical Center in Baltimore were asked to determine what would be optimal and safe dosages of a vaccine produced by pharmaceutical company sanofi pasteur to ensure a person was properly protected from the avian influenza virus H5N1, the deadly form that’s surfaced in Europe and Asia.
Sanofi pasteur provided researchers with 8,000 trial doses of the vaccine that was specifically designed to fight H5N1 avian flu virus, company spokesman John Abrams said.
James Campbell, the principal investigator for the study and assistant professor of pediatrics, said he and his collaborators at the University of Rochester and the University of California in Los Angeles determined that the vaccine should be administered in two doses.
“A single dose of the vaccine did not give people protective levels of antibodies in their blood,” he said.
Four different dose amounts were tested: 7.5, 15, 45 and 90 micrograms, Campbell said. The scientists found that the two largest amounts produced the most significant immune response.
The vaccine appears to be safe, Campbell said, adding that the 154 Maryland volunteers were monitored for red or sore arms or other adverse reactions to the intravenous shots.
“Still, whenever you test a new vaccine, you have to start with the assumption that there might be something that you weren’t expecting but could happen,” he said.
On Oct. 31, the scientists will draw new blood samples from the Maryland volunteers and take a last measure of antibodies in their blood. Those results will be compared to blood drawn before the first vaccine was administered and at two other stages during the study.
Antibodies are what the immune system makes to fight a foreign invader or disease, Campbell said. More antibodies detected in the blood means that the body is developing a better immune response to fight the avian flu.
Campbell said he didn’t know when, or whether, the vaccine would make it to the market.
“At this point, it’s hard to predict, but if the need arose, doses will be made,” he said.
&nb
