AlaskaDenise
In Memoriam
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09/13/06
MARY T. ROBBINS
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[FONT=Verdana,Arial]Three residents of Charlestown retirement community on Maiden Choice Lane will wrap up their involvement in a clinical trial program to develop an effective avian flu vaccine next month. [/FONT]
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The residents, who could not be named by clinical trial officials due to privacy concerns, will have their final examinations in October.
Researchers at the University of Maryland School of Medicine in Baltimore began to enroll volunteers in the study in March.
The volunteers were needed for two clinical trials of a revised form of a pandemic vaccine against avian influenza to see if the vaccine would stimulate immune responses if given in lower doses.
One trial was conducted for healthy adults ages 18 to 49.
The other trial, which involved the Charlestown residents, was conducted for healthy adults 65 and older.
Results of the study for the first age group were published recently in the New England Journal of American Medicine. It reported that only 50 percent of participants responded to the vaccine, said Dr. Wilbur Chen, assistant professor of medicine at the University of Maryland School of Medicine and co-principal investigator of the avian flu vaccine for the elderly.
"In the elderly, we wanted to test different doses," he said. "We predicted it would require higher doses."
Medical personnel working on the study hoped that adding a compound called an adjuvant would improve the vaccine's response, Chen said.
In this case, the adjuvant was aluminum hydroxide, the same compound found in other vaccines approved in the United States, including the one for tetanus.
Four different dosages, half with aluminum hydroxide added and half without, were given the volunteers in the study group, Chen said.
The trial was a double-blind trial, meaning neither Chen and the other administrators nor the volunteers knew which level of dosage was being administered or whether the volunteer was receiving the vaccine containing aluminum hydroxide.
The study, conducted simultaneously at other medical facilities around the country, involved a total of about 600 volunteers.
It ended Aug. 17.
Of the 600 volunteers, 101 were involved in the adult trial at the University of Maryland School of Medicine.
To participate, volunteers had to meet a strict set of guidelines regarding their medical histories and undergo a physical examination.
They were given the vaccine when the trial began.
A month later, participants received a second dose of the vaccine.
In October, they will have their final follow-up exam.
"We follow them out for six months and get their antibody levels," Chen said. "That is how we are able to tell, based on the blood response, how they are doing with the vaccine.
"So far, it looks pretty safe. We have not been seeing a lot of adverse reactions."
Nothing could happen without the help of the senior volunteers, he added.
"When we are working with the elderly, we like to consider them a part of the medical team," said Chen, who has spoken at Charlestown about the clinical study and about the avian flu. "A lot of data we are expecting from them is by their own report."
Participants were required to keep a daily diary and take their own temperatures.
While the study on the vaccine offers some cause for hope, Chen remains cautious about Maryland's preparedness regarding the avian flu.
"We spend a lot of money coming up with rapid-response teams, not just for the avian flu," he said. "It seems that no matter how much we prepare or account for, we are never really prepared enough. At least we are seeing a vaccine that we think would be prepared for the bird flu."
If a public health threat involving the bird flu were to emerge, Chen said a stockpile of the vaccine exists.
"Even though it's experimental, we still would be able to deploy it and have some confidence that it would not cause people harm," he said.
.
[/FONT]
09/13/06
MARY T. ROBBINS
Email this story to a friend
[FONT=Verdana,Arial]Three residents of Charlestown retirement community on Maiden Choice Lane will wrap up their involvement in a clinical trial program to develop an effective avian flu vaccine next month. [/FONT]
[FONT=Verdana,Arial]
The residents, who could not be named by clinical trial officials due to privacy concerns, will have their final examinations in October.
Researchers at the University of Maryland School of Medicine in Baltimore began to enroll volunteers in the study in March.
The volunteers were needed for two clinical trials of a revised form of a pandemic vaccine against avian influenza to see if the vaccine would stimulate immune responses if given in lower doses.
One trial was conducted for healthy adults ages 18 to 49.
The other trial, which involved the Charlestown residents, was conducted for healthy adults 65 and older.
Results of the study for the first age group were published recently in the New England Journal of American Medicine. It reported that only 50 percent of participants responded to the vaccine, said Dr. Wilbur Chen, assistant professor of medicine at the University of Maryland School of Medicine and co-principal investigator of the avian flu vaccine for the elderly.
"In the elderly, we wanted to test different doses," he said. "We predicted it would require higher doses."
Medical personnel working on the study hoped that adding a compound called an adjuvant would improve the vaccine's response, Chen said.
In this case, the adjuvant was aluminum hydroxide, the same compound found in other vaccines approved in the United States, including the one for tetanus.
Four different dosages, half with aluminum hydroxide added and half without, were given the volunteers in the study group, Chen said.
The trial was a double-blind trial, meaning neither Chen and the other administrators nor the volunteers knew which level of dosage was being administered or whether the volunteer was receiving the vaccine containing aluminum hydroxide.
The study, conducted simultaneously at other medical facilities around the country, involved a total of about 600 volunteers.
It ended Aug. 17.
Of the 600 volunteers, 101 were involved in the adult trial at the University of Maryland School of Medicine.
To participate, volunteers had to meet a strict set of guidelines regarding their medical histories and undergo a physical examination.
They were given the vaccine when the trial began.
A month later, participants received a second dose of the vaccine.
In October, they will have their final follow-up exam.
"We follow them out for six months and get their antibody levels," Chen said. "That is how we are able to tell, based on the blood response, how they are doing with the vaccine.
"So far, it looks pretty safe. We have not been seeing a lot of adverse reactions."
Nothing could happen without the help of the senior volunteers, he added.
"When we are working with the elderly, we like to consider them a part of the medical team," said Chen, who has spoken at Charlestown about the clinical study and about the avian flu. "A lot of data we are expecting from them is by their own report."
Participants were required to keep a daily diary and take their own temperatures.
While the study on the vaccine offers some cause for hope, Chen remains cautious about Maryland's preparedness regarding the avian flu.
"We spend a lot of money coming up with rapid-response teams, not just for the avian flu," he said. "It seems that no matter how much we prepare or account for, we are never really prepared enough. At least we are seeing a vaccine that we think would be prepared for the bird flu."
If a public health threat involving the bird flu were to emerge, Chen said a stockpile of the vaccine exists.
"Even though it's experimental, we still would be able to deploy it and have some confidence that it would not cause people harm," he said.
.
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