US rushing swine flu vaccine clinical trials

Editor's NOTE:

This piece is included in way of background to help demonstrate that the timing of the initial "Swine Flu" presentation last year demanded an expedited vaccine development phase and an accelerated vaccine clinical trial phase.

As mentioned in my "Primer" HERE... the data from these clinical trials is incomplete to date and must be carefully monitored. Nevertheless, members of high-risk groups should strongly consider getting the vaccine when it is made available as to date the reported complication rate appears to be acceptably low.

--Dr. J. P. Hubert

By: Deborah Shlian
July 28, 2009
Miami Health Care Examiner

As the swine flu continues to rapidly move across the globe, the World Health Organization has stopped asking governments to report new cases, claiming the effort is too great now that the disease has become so widespread. Instead, the focus is on developing strategies for preventing what some experts fear will be a new, more serious outbreak of swine flu in the fall and winter months just when seasonal flu arrives.

Pharamceutical companies are rushing to develop a vaccine by early fall. Clinical trials have already started in Australia. Canadian trials will begin by September or early October. Federal health officials announced that the first US clinical trials will begin in August and will be conducted in what Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Disease described as “a two month compressed time frame” in which about 2400 volunteers will be tested. The initial tests will be of vaccines made by Sanofi-Pasteur, a European company, and CLS Biotherapies, an Australian company that has supplied seasonal flu shots in the US for years. A third company, Novartis, is conducting separate trials for FDA licensing.

Adult volunteers for the clinical trials will be recruited at 8 separate sites including Emory University in Atlanta, the University of Maryland School of Medicine in Baltimore, Vanderbilt University in Nashville, Baylor College of Medicine in Houston, Children’s Hospital Medical Center in Cincinnati, Group Health Cooperative in Seattle, the University Iowa in Iowa City, and St. Louis University.

Initial studies will determine whether one or two 15-microgram doses of A/H1N1 swine flu vaccine are needed to produce an immune response in healthy adult volunteers (18 to 64 years) and elderly people (65 years and older).

The doses will be given 21 days apart. If there are early indications that the vaccines are safe, similar trials in healthy children (six months to 17 years) will begin. According to Fauci, later tests may include pregnant women, who are at higher risk for swine flu complications.

Vaccines will be given to different sets of volunteers before, after or at the same time as the seasonal flu vaccine. Every volunteer will be monitored for negative side effects including allergic reactions to the chicken eggs that the vaccines are grown in.

Researchers will also look out for Guillain-Barré syndrome , a rare reaction to any vaccine which can cause fever, serious nerve damage and muscle weakness. The 1976 vaccination of 40 million people after a swine flu outbreak in Fort Dix, N. J., was halted after some people developed the syndrome. However, the vaccine was never proved to be the cause. According to a 2009 worldwide literature review, approximately one person in 100,000 develops Guillain-Barré syndrome for unknown reasons. Unfortunately because the US vaccine trials are so small, it is unlikely to pick up such a rare side effect. “You’d have to vaccinate several hundred thousand or millions of people to do that,” Fauci said.

In addition to checking for adverse reactions, volunteers will have their blood tested about three weeks after the shot to see if antibodies to the virus have developed. Those with high levels of antibodies to the specific strain should be immune to the infection or at the very worst, get only a mild case of the flu if exposed to it.

Once these trials are completed and the vaccine is determined to be safe and effective, health officials can then make specific recommendations as to how to conduct a vaccination program and who should be vaccinated. (Editor's emphasis throughout)

Assuming things go according to schedule, the hope is to have as many as 160 million doses ready in the US by mid October and then 80 million doses a month later. Depending on how much vaccine is available and assuming most individuals will require two shots, it could take until March to vaccinate the full U.S. population of 300 million people.

None of the first trials will test a vaccine containing an adjuvant, which is an additive -generally an oil-water emulsion- that stimulates the immune system to react more strongly and helps to stretch the number of doses of vaccine needed. Adjuvants are common in veterinary vaccines and tend to cause more side effects. They are not now used in flu shots in the United States. But they are “not off the board,” Fauci said. “We’ve developed a mix-and-match protocol for them, but we want to see the data on vaccine safety first.” According to a report from Reuters, the U.S. Health and Human Services Department has contracted for 120 million doses of adjuvant which they might use if the flu mutates into a more dangerous form and the demand for more shots than are available results.

Federal advisers plan a meeting tomorrow to discuss who should receive the vaccination.