Although much of the media attention has subsided concerning the novel H1N1 virus, or swine flu, the reality is that the virus continues to rapidly spread worldwide. In fact, the World Health Organization has declared it a Phase Six pandemic, the highest possible rating. The Centers for Disease Control and Prevention reports that more than 70 countries have been affected, and the number of confirmed cases is approaching 100,000 with more than 400 deaths. In the United States, there are more than 40,000 confirmed cases and 260 deaths.
To combat spread of the H1N1 virus, the Food and Drug Administration has fast-tracked the research needed to produce an H1N1 vaccine. The goal is to begin clinical trials in August and have an approved vaccine ready for distribution by October. There are fewer than 10 sites in the nation taking part in this study, but one is local. Dr. Robert Jeanfreau, a principal investigator in the H1N1 vaccine study and internal medicine physician with East Jefferson General Hospital, is working in conjunction with Benchmark Research to determine the immunologic response to the proposed vaccine.
"The spread of the H1N1 virus has commanded the attention of health organizations and pharmaceutical companies throughout the world and has drawn them together to quickly find a vaccine," Dr. Jeanfreau says.
The H1N1 vaccine study is expected to last 30 to 45 days. Clinical trial participants receive an initial physical, a pre-screening evaluation and have blood drawn to establish baseline antibody levels. Participants are then given the vaccine and asked to keep a journal of any injection site symptoms that may occur. Side effects of the vaccine are expected to be minimal and may include soreness and redness at the injection site. Concluding their portion of the study, participants return for a final blood test to record the rise in antibody levels. Officials expect the results to confirm the safety and effectiveness needed to approve production.
"We hope to see a fourfold increase in antiviral antibodies in our participants from first to final blood draw," Dr. Jeanfreau says. "If we see that increase, it lets us know that they are protected and immunized."
H1N1 virus, like the common flu, is contagious and can be spread by contact or when it becomes airborne through coughing and sneezing. Both viruses may cause fever, chills, headache, nausea and other flulike symptoms. One of the primary differences is that humans have not been able to develop immunity or resistance because it is completely different from the common flu virus. That is why, if successful, the H1N1 vaccine will be administered in addition to the normal flu shot already in development for this flu season.
To help protect against acquiring the swine flu, health care professionals say one of the first lines of defense is to practice good hand hygiene and to use and dispose of a tissue when coughing or sneezing. If a tissue is unavailable, coughing or sneezing into your arm is advised. Hand washing can help eliminate germs and should be performed with soap and warm water for at least 20 seconds or through the use of alcohol-based gels. In addition, it is always advisable to avoid close contact with someone who has the virus and to clean areas at home and work with disinfectants.
"The study is still seeking participants in our area, especially those between three months and 6 years old and those 65 and older," Dr. Jeanfreau says. "Everyone wants safe medications and vaccines. This a great way to help yourself, your family and the community in a safe and controlled study."
Those interested in participating in the H1N1 vaccine study can call 504-888-9493.