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U.S. Swine Flu Vaccine Trials Set to Begin
Date:7/22/2009

Announcement comes day after first such program in world started in Australia

WEDNESDAY, July 22 (HealthDay News) -- The United States is readying its first human trials of an experimental vaccine to protect against the H1N1 swine flu virus, officials announced Wednesday.

Two possible vaccines will be tested at eight institutions around the country under the auspices of the National Institute of Allergy and Infectious Diseases (NIAID).

The purpose of the trials, said NIAID Director Dr. Anthony S. Fauci in a prepared statement, is to "determine whether the vaccines are safe and to assess their ability to induce protective immune responses. These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall."

The announcement follows Tuesday's revelation that two Australian biotechnology companies have started inoculating adult volunteers in the world's first H1N1 swine flu vaccine trials. Those trials, as well as the trials planned in the United States, hope to produce an effective shot against the virus that has so far killed more than 700 people worldwide.

In the United States, several trials will be conducted concurrently, officials said.

"I think the speed with which they [federal officials] got this going is impressive," said one expert, Dr. John J. Treanor, professor of medicine and of microbiology and immunology at the University of Rochester Medical Center, in New York. "They have a really well-organized clinical trials infrastructure that is uniquely posed to do these kinds of studies when there's an emergency situation like there is now."

One of the NIAID studies will try to determine if one or two 15-microgram doses of the candidate H1N1 vaccine are sufficient to provoke an immune response in healthy adults aged 18 to 64 and in people aged 65 and older. Studies will also look at whether one or two doses of 30 micrograms are more effective.

The two-dose regimens will be given three weeks apart. Two manufacturers, Sanofi Pasteur and CSL Biotherapies, produced the vaccines.

If these trials seem safe, the vaccines will also be tested in children aged 6 months to 17 years, according to the NIAID statement.

"The response to the vaccine may vary in different age groups," said Dr. Karen Kotloff, a professor of pediatrics and lead investigator at the Vaccine and Treatment Evaluation Unit at the University of Maryland, one of the medical centers chosen for the trials. In a statement released by the university, Kotloff explained that age could make a difference in vaccine response because "young people have not seen a flu virus like this before," whereas older Americans might have been exposed to H1N1 type strains in the past.

Additional trials will look at concurrent administration of the swine flu vaccine with regular, seasonal vaccine.

"It makes sense to test the combined swine flu and seasonal flu vaccines because there are some populations in whom both vaccines are indicated," Treanor said. "It would certainly be easier to give them at the same time but these trials are mostly focused on making sure they don't interfere with each other in some way and that they still get a good response."

Besides the University of Maryland School of Medicine, other centers taking part in the trials include the University of Iowa; St. Louis University; Baylor College of Medicine in Houston; Children's Hospital Medical Center, Cincinnati; Emory University in Atlanta, Group Health Cooperative, Seattle; and Vanderbilt University in Nashville, officials said.

In Australia, Adelaide-based drug manufacturer Vaxine initiated trials Monday with 300 participants, while Melbourne's CSL has 240 people in its seven-month study. Australia had 14,703 confirmed cases of swine flu as of Wednesday, and at least 41 deaths, according to the Associated Press. The winter flu season is well under way in the Southern Hemisphere.

Both companies said it would be at least six weeks before results of the initial trials are known.

As was the case when the H1N1 swine flu virus first surfaced in Mexico and then the United States in mid-April, infections in the Southern Hemisphere continue to be relatively mild, much like the seasonal flu, and recovery is fairly quick.

As vaccine development continues, the H1N1 swine flu virus continues to sweep around the world.

Last Friday, the CDC was reporting 40,617 confirmed cases of H1N1 infection and 263 deaths in the United States, although officials believe that more than 1 million Americans have been stricken with the swine flu. The reason for the disparity: The virus continues to produce mild symptoms and patients typically recover quickly.

Officials expect to see a new outbreak of H1N1 swine flu in the United States in the fall. It will most likely start earlier than seasonal flu, Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention, said during a Friday press conference. Seasonal flu typically surfaces in late fall.

Unlike seasonal flu, the H1N1 flu continues to pose more problems for younger people, Schuchat added. "There are higher attack rates and hospitalizations in younger adults and children," she said.

Meanwhile, Canadian health officials reported Wednesday the nation's first case of Tamiflu-resistant swine flu virus. A 60-year-old Quebec man was given the antiviral drug after his son fell ill with the virus. The strain doesn't seem to have spread beyond the reported individual case, the AP said.

U.S. Human Cases of H1N1 Flu Infection
(As of July 17, 2009, 11 AM ET)
States and Territories* # of
confirmed and
probable cases
Deaths
Alabama
477
 
Alaska
218
 
Arizona
762
11
Arkansas
47
 
California
3161
52
Colorado
155
 
Connecticut
1581
7
Delaware
364
 
Florida
2188
12
Georgia
174
1
Hawaii
722
1
Idaho
143
 
Illinois
3357
15
Indiana
282
1
Iowa
165
 
Kansas
186
 
Kentucky
143
 
Louisiana
232
 
Maine
133
 
Maryland
732
3
Massachusetts
1343
5
Michigan
515
8
Minnesota
660
3
Mississippi
219
 
Missouri
70
1
Montana
94
 
Nebraska
264
1
Nevada
406
 
New Hampshire
247
 
New Jersey
1350
14
New Mexico
232
 
New York
2670
57
North Carolina
395
4
North Dakota
61
 
Ohio
161
1
Oklahoma
176
1
Oregon
465
5
Pennsylvania
1914
8
Rhode Island
188
2
South Carolina
244
 
South Dakota
39
 
Tennessee
247
1
Texas
4975
24
Utah
966
14
Vermont
59
 
Virginia
319
2
Washington
636
4
Washington, D.C.
45
 
West Virginia
227
 
Wisconsin
6031
5
Wyoming
106
 
Territories
American Samoa
8
 
Guam
1
 
Puerto Rico
18
 
Virgin Islands
44
 
TOTAL (55)*
40,617 cases
263 deaths
*includes the District of Columbia, American Samoa, Guam,
Puerto Rico and the Virgin Islands

Source: U.S. Centers for Disease Control and Prevention

More information

There's more on the flu at the U.S. Department of Health and Human Services.



SOURCES: John J. Treanor M.D., professor, medicine, microbiology and immunology, University of Rochester Medical Center, Rochester, N.Y.; July 22, 2009, news releases, U.S. National Institute of Allergy and Infectious Diseases, and University of Maryland School of Medicine; July 17, 2009, teleconference with Anne Schuchat, M.D., director, National Center for Immunization and Respiratory Diseases, U.S. Centers for Disease Control and Prevention; Associated Press


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