H1N1 Influenza Vaccine Trial in People with Asthma

NIH prepares to launch 2009 H1N1 influenza vaccine trial in people with asthma.

The National Institutes of Health is preparing to launch the first government-sponsored clinical trial to determine what dose of the 2009 H1N1 influenza vaccine is needed to induce a protective immune response in people with asthma, especially those with severe disease. The study is cosponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of NIH.

"People with severe asthma often take high doses of glucocorticoids that can suppress their immune system, placing them at greater risk for infection and possibly serious disease caused by 2009 H1N1 influenza virus," says NIAID Director Anthony S. Fauci, M.D. "We need to determine the optimal dose of 2009 H1N1 influenza vaccine that can be safely administered to this at-risk population and whether one or two doses are needed to produce an immune response that is predictive of protection."

The study plan has been submitted to the Food and Drug Administration for review. With FDA allowing it to proceed, the clinical trial will be conducted at seven sites across the United States that participate in NHLBI's Severe Asthma Research Program.

This program already has a well-characterized group of participants with mild, moderate or severe asthma who may be eligible for this new study. These groups are largely distinguished by the amount and frequency of glucocorticoids needed to control asthma symptoms. People with mild disease may not need glucocorticoids, or may require low doses of inhaled glucocorticoids; those with moderate asthma need low to moderate doses of inhaled glucocorticoids; and those with severe asthma need high doses of inhaled glucocorticoids and frequently use oral glucocorticoids as well.

Individuals who already have been infected with 2009 H1N1 influenza or have received a 2009 H1N1 influenza vaccination will not be eligible for the study.

"The results of this study will have immediate implications for individuals with severe asthma as well as those who have milder asthma," says NHLBI Director Elizabeth G. Nabel, M.D.
Early results from other clinical trials of 2009 H1N1 influenza vaccines in healthy adults have shown that a single 15-microgram dose of 2009 H1N1 influenza vaccine without adjuvant is well tolerated and induces a strong immune response in most participants. The same vaccine also generates an immune response that is expected to be protective in healthy children ages 10 to 17 years. Ongoing trials are comparing the immune response to one and two doses of 15- or 30-micrograms of vaccine given three weeks apart in various populations.

The Centers for Disease Control and Prevention has recommended that certain at-risk populations receive the new H1N1 vaccine as a priority before the general population. These target populations include pregnant women, health care providers and individuals with underlying chronic medical conditions, including asthma.

People who have severe asthma may be particularly at risk for infection with the 2009 H1N1 influenza virus. A report published in 2004 suggested that some people who took high doses of glucocorticoids to treat their asthma may receive less protection from influenza vaccines against some strains of influenza. Early in the 2009 H1N1 flu outbreak a CDC review of hospital records found that people with asthma have a four-fold increased risk of being hospitalized with infection compared to the general population.

The study will enroll approximately 350 people with mild, moderate and severe asthma. Participants will be organized into two groups: those with mild or moderate asthma and those with severe asthma. Half of the participants in each group will receive a 15-microgram dose of vaccine, and the other half a 30-microgram dose. Three weeks later, each participant will receive a second dose of the same amount. The strength of the immune response induced by the vaccine will be determined in blood samples by measuring the level of antibodies against 2009 H1N1 flu virus.

Safety data will be collected and examined throughout the course of the study by trial investigators and by an independent safety monitoring committee. Participants will be monitored for any side effects they may experience because of the vaccine, as well as asthma attacks that occur during the study period.

The vaccine to be used in the trial, manufactured by Novartis, contains inactivated 2009 H1N1 influenza virus and therefore cannot cause anyone to become infected with the virus.

The trial will be conducted at the following locations:
Cleveland Clinic, Ohio
Emory University, Atlanta
University of Pittsburgh Asthma Institute
University of Virginia, Charlottesville
University of Wisconsin, Madison
Wake Forest University, Winston-Salem, N.C.
Washington University School of Medicine, St. Louis

Detailed information about this study can be found on the ClinicalTrials.gov Web site at http://clinicaltrials.gov/ct2/results?term=H1N1+AND+asthma.

Additional information about NIAID-sponsored clinical trials of candidate H1N1 vaccines can be found here: Clinical Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported Vaccine and Treatment Evaluation Units

(http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm); Pediatric Trials of Candidate 2009 H1N1 Vaccine at NIAID Vaccine and Treatment Evaluation Units (VTEUs)

(http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm); NIAID Launches 2009 H1N1 Influenza Vaccine Trial in Pregnant Women

(http://www3.niaid.nih.gov/news/QA/H1N1pregnanttrials.htm); NIH Launches 2009 H1N1 Influenza Vaccine Trial in HIV-Infected Pregnant Women: Trial in HIV-Infected Children, Youth to Begin Next Week

(http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1HIVTrials.htm).
Visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza.

Also, visit NIAID's Web sites for more information about flu(http://www3.niaid.nih.gov/topics/Flu/) and asthma (http://www3.niaid.nih.gov/topics/asthma/) and NHLBI's Web site for more information about asthma (http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html) .

For additional information about the NHLBI's Severe Asthma Research Program, contact the NHLBI Office of Communications at (301) 496-4236 or e-mail nhlbi_news@nhlbi.nih.gov.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.



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Swine Flu - What You Need to Know

"Information is the best prevention".

This pandemic is still a very serious threat to the people. Medical companies are racing against time to combat this dreaded disease which already claimed thousands.

As the government scrambles to provide vaccine for Swine Flu and contain the spread of the disease, perhaps the best tool available for you is the right information.

What is Swine Flu and how is it different from varieties of influenza we've seen before?

H1N1, or "Swine Flu" contains genetic material from swine, avian and human flu viruses. H1N1 viruses often circulate harmlessly, but since it's a new type of virus, humans don't normally have immunity to it. There are predictions worldwide about the spread of Swine Flu, but nobody is sure how far the disease will spread.

What are the symptoms?

These include:

* Fever
* Cough
* Sore throat
* Runny nose
* Body aches
* Chills
* Fatigue

Some cases also involve diarrhea and vomiting.

These symptoms are relatively common in most types of influenza. Your doctor can give you a Swine Flu test, though the results are not always definitive.

A fever is defined as having a body temperature of 100 degrees or greater.

Swine flu can also cause neurological problems in children, as do other types of flu. The disease is fatal in rare cases.

Who's at the highest risk?

Most U.S. cases have involved young adults and older children. A large number have involved those with morbid obesity.

Experts still caution that those at the highest risk from Swine Flu are young children, the elderly, those with immune disorders and other chronic illnesses.

How can I tell of co-workers, family members or others have Swine Flu?

It's virtually impossible to tell, as Swine Flu symptoms are similar to those of other types of flu. Still, experts advise you to stay six feet from those who appear sick. It's not necessary to wear a face mask, but it can help prevent you from spreading your flu virus to others.

How can I avoid infection

The CDC says hand washing is one of the best ways to reduce your risk of infection. Also, staying away from those who exhibit symptoms is also effective. A personal distance of six feet is recommended.

All household surfaces should be kept clean. Experts say the flu virus (H1N1 included) can stay alive on doorknobs, books, counters, sinks and desks for up to 8 hours.

What vaccines are available?

Vaccines are being prepared in large numbers. Millions of doses will be available in October with more being distributed each month thereafter. The CDC says children ages 6 months to 19 should get a flu shot each year.

What medications are effective?

Tamiflu (oseltamivir) and Relenza (zanamivir) are thought to be the most effective medications to combat H1N1. Doctors advise taking these drugs as soon as possible after symptoms are exhibited. The CDC adds that those who have been to areas with widespread infection should talk to their doctors about taking one of these antiviral medicines.

Health officials don't advise stockpiling Tamiflu and Relenza, though there have been reports in recent years about public health workers doing just that. Still, the government recommends leaving available medicines for those truly in need.

How do I prepare my family for a possible major outbreak?

The government web site Flu.gov advises that you keep a two week supply of food and water in the house. You should also make sure you have a large supply of any prescription drugs on hand. Make sure your children know to always wash their hands and stay away from others who are sick. Parents should cover coughs and sneezes with tissues and model that behavior for the children.

Talk with family members and loved ones about how they would be cared for if they got sick, or what will be needed to care for them in your home. Parents should make plans for child care in the event they themselves become sick.

What if a family member becomes sick?

Call your doctor. If you, your spouse or the kids are coughing and sneezing it could just be a cold. But if there's a fever, headache and other flu symptoms, that's an indication that it could be Swine Flu or some other strain of season influenza.

Also, anyone who's sick should stay home and avoid public areas.

What about travel? Is it safe?

Experts advise caution when traveling to Mexico since there have been large numbers of people infected with Swine Flu there. But you should check with your airline, and websites for the CDC and WHO before traveling since new advisories are constantly posted.

Why have so many people died from Swine Flu in Mexico but not in the U.S.?

Nobody is excactly sure, but it's possible that Americans generally get better, faster medical care. But some experts worry that the number of U.S. deaths could increase as the disease spreads.

Should we avoid pork?

That's not necessary. Swine Flu or H1N1 virus is spread between individuals or by touching surfaces contaminated with the virus. Pork has nothing to do with it.


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WHO Warns Of Severe Form Of Swine Flu

WASHINGTON (Reuters) - Doctors are reporting a severe form of swine flu that goes straight to the lungs, causing severe illness in otherwise healthy young people and requiring expensive hospital treatment, the World Health Organisation said Friday.

Some countries are reporting that as many as 15 percent of patients hospitalized with the new H1N1 pandemic virus need intensive care, further straining already overburdened healthcare systems, WHO said in an update on the pandemic.

"During the winter season in the southern hemisphere, several countries have viewed the need for intensive care as the greatest burden on health services," it said.

"Preparedness measures need to anticipate this increased demand on intensive care units, which could be overwhelmed by a sudden surge in the number of severe cases."

Earlier, WHO reported that H1N1 had reached epidemic levels in Japan, signalling an early start to what may be a long influenza season this year, and that it was also worsening in tropical regions.

"Perhaps most significantly, clinicians from around the world are reporting a very severe form of disease, also in young and otherwise healthy people, which is rarely seen during seasonal influenza infections," WHO said.

"In these patients, the virus directly infects the lung, causing severe respiratory failure. Saving these lives depends on highly specialized and demanding care in intensive care units, usually with long and costly stays."


MINORITIES AT RISK

Minority groups and indigenous populations may also have a higher risk of being severely ill with H1N1.

"In some studies, the risk in these groups is four to five times higher than in the general population," WHO said.

"Although the reasons are not fully understood, possible explanations include lower standards of living and poor overall health status, including a high prevalence of conditions such as asthma, diabetes and hypertension."

WHO said it was advising countries in the Northern Hemisphere to prepare for a second wave of pandemic spread. "Countries with tropical climates, where the pandemic virus arrived later than elsewhere, also need to prepare for an increasing number of cases," it said.

Every year, seasonal flu infects between 5 percent and 20 percent of a given population and kills between 250,000 and 500,000 people globally. Because hardly anyone has immunity to the new H1N1 virus, experts believe it will infect far more people than usual, as much as a third of the population.

It also disproportionately affects younger people, unlike seasonal flu which mainly burdens the elderly, and thus may cause more severe illness and deaths among young adults and children than seasonal flu does.

"Data continue to show that certain medical conditions increase the risk of severe and fatal illness. These include respiratory disease, notably asthma, cardiovascular disease, diabetes and immunosuppression," WHO said.

"When anticipating the impact of the pandemic as more people become infected, health officials need to be aware that many of these predisposing conditions have become much more widespread in recent decades, thus increasing the pool of vulnerable people."

WHO estimates that more than 230 million people globally have asthma, and more than 220 million have diabetes. Obesity may also worsen the risk of severe infection, WHO said.

The good news -- people infected with AIDS virus do not seem to be at special risk from H1N1, WHO said.


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