 |
|
NIAID set to launch clinical trials to test 2009 H1N1 influenza vaccine candidates
July 23, 2009Scientists in a network of medical research institutions across the United States are set to begin a series of clinical trials to gather critical data about influenza vaccines, including two candidate H1N1 flu vaccines. The research will be under the direction of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
"With the emergence of the 2009 H1N1 influenza virus, we have undertaken a collaborative and efficient process of vaccine development that is proceeding in stepwise fashion," says NIAID Director Anthony S. Fauci, M.D.
After the isolation and characterization of the virus, the U. S. Centers for Disease Control and Prevention generated and distributed a 2009 H1N1 seed virus to vaccine manufacturers for the development of vaccine pilot lots for testing in clinical trials.
"Now, NIAID will use our longstanding vaccine clinical trials infrastructure-the Vaccine and Treatment Evaluation Units-to help quickly evaluate these pilot lots to determine whether the vaccines are safe and to assess their ability to induce protective immune responses," says Dr. Fauci. "These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall."
Initial studies will look at whether one or two 15 microgram doses of H1N1 vaccine are needed to induce a potentially protective immune response in healthy adult volunteers (aged 18 to 64 years old) and elderly people (aged 65 and older). Researchers also will assess whether one or two 30 microgram doses are needed. The doses will be given 21 days apart, testing two manufacturers' vaccines (Sanofi Pasteur and CSL Biotherapies). If early information from those trials indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will begin.
A concurrent set of trials will look at the safety and immune response in healthy adult and elderly volunteers who are given the seasonal flu vaccine along with a 15 microgram dose of 2009 H1N1 vaccine. The H1N1 vaccine would be given to different sets of volunteers either before, after, or at the same time as the seasonal flu vaccine. If early information from those studies indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will start.
A panel of outside experts will conduct a close review of the safety data from these trials to spot any safety concerns in real time. Information from these studies in healthy people will help public health officials develop recommendations for immunization schedules, including the optimal dosage and number of doses for multiple age groups, including adults, the elderly, and children. Data may also be used to support decisions about the best recommendations for people in high risk groups, including pregnant women and people whose immune systems are weakened or otherwise compromised.
The trials are being conducted in a compressed timeframe in a race against the possible autumn resurgence of 2009 H1N1 flu infections that may occur at the same time as seasonal influenza virus strains begin to circulate widely in the Northern Hemisphere.
Close collaboration among NIAID, the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (a component of the Department of Health and Human Services) was key to launching the trials quickly while ensuring high standards. Following initial discussions between the agencies on trial design, NIAID prepared the protocols and submitted them to the FDA for review. FDA rapidly completed the necessary reviews and approved the trial protocols.
Since 1962, NIAID's Vaccine and Treatment Evaluation Units (VTEUs) have been intensively involved in the successful development and clinical testing of vaccines and treatments against many pathogens that threaten the health of people in the United States and around the world. Among the vaccines tested have been those that prevent seasonal influenza, H5N1 avian influenza and pneumococcal pneumonia.
The VTEU network consists of eight university research hospitals and medical organizations across the United States that provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases.
An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. Results are expected to be available weeks after the trials begin.
NIAID's Vaccine and Treatment Evaluation Units include the following:
* Baylor College of Medicine, Houston
* Children's Hospital Medical Center, Cincinnati
* Emory University, Atlanta
* Group Health Cooperative, Seattle
* Saint Louis University, St. Louis
* University of Iowa, Iowa City
* University of Maryland School of Medicine, Baltimore
* Vanderbilt University, Nashville, Tenn.
NIH/National Institute of Allergy and Infectious Diseases
"Now, NIAID will use our longstanding vaccine clinical trials infrastructure-the Vaccine and Treatment Evaluation Units-to help quickly evaluate these pilot lots to determine whether the vaccines are safe and to assess their ability to induce protective immune responses," says Dr. Fauci. "These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall."
Initial studies will look at whether one or two 15 microgram doses of H1N1 vaccine are needed to induce a potentially protective immune response in healthy adult volunteers (aged 18 to 64 years old) and elderly people (aged 65 and older). Researchers also will assess whether one or two 30 microgram doses are needed. The doses will be given 21 days apart, testing two manufacturers' vaccines (Sanofi Pasteur and CSL Biotherapies). If early information from those trials indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will begin.
A concurrent set of trials will look at the safety and immune response in healthy adult and elderly volunteers who are given the seasonal flu vaccine along with a 15 microgram dose of 2009 H1N1 vaccine. The H1N1 vaccine would be given to different sets of volunteers either before, after, or at the same time as the seasonal flu vaccine. If early information from those studies indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will start.
A panel of outside experts will conduct a close review of the safety data from these trials to spot any safety concerns in real time. Information from these studies in healthy people will help public health officials develop recommendations for immunization schedules, including the optimal dosage and number of doses for multiple age groups, including adults, the elderly, and children. Data may also be used to support decisions about the best recommendations for people in high risk groups, including pregnant women and people whose immune systems are weakened or otherwise compromised.
The trials are being conducted in a compressed timeframe in a race against the possible autumn resurgence of 2009 H1N1 flu infections that may occur at the same time as seasonal influenza virus strains begin to circulate widely in the Northern Hemisphere.
Close collaboration among NIAID, the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (a component of the Department of Health and Human Services) was key to launching the trials quickly while ensuring high standards. Following initial discussions between the agencies on trial design, NIAID prepared the protocols and submitted them to the FDA for review. FDA rapidly completed the necessary reviews and approved the trial protocols.
Since 1962, NIAID's Vaccine and Treatment Evaluation Units (VTEUs) have been intensively involved in the successful development and clinical testing of vaccines and treatments against many pathogens that threaten the health of people in the United States and around the world. Among the vaccines tested have been those that prevent seasonal influenza, H5N1 avian influenza and pneumococcal pneumonia.
The VTEU network consists of eight university research hospitals and medical organizations across the United States that provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases.
An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. Results are expected to be available weeks after the trials begin.
NIAID's Vaccine and Treatment Evaluation Units include the following:
* Baylor College of Medicine, Houston
* Children's Hospital Medical Center, Cincinnati
* Emory University, Atlanta
* Group Health Cooperative, Seattle
* Saint Louis University, St. Louis
* University of Iowa, Iowa City
* University of Maryland School of Medicine, Baltimore
* Vanderbilt University, Nashville, Tenn.
NIH/National Institute of Allergy and Infectious Diseases
H1n1 Influenza Current Events and H1n1 Influenza News RSSAsthma a significant risk factor for complications in children with H1N1
A new study on pediatric H1N1 influenza admissions has found that asthma is a significant risk factor for severe disease in children with pandemic H1N1 compared with the seasonal flu.
Mechanical ventilation for patients with lung damage don't always work as planned
As more Canadians are diagnosed with H1N1 influenza infection, some will be admitted to hospital. The most severely affected may be treated in the intensive care unit (ICU) and placed on a mechanical ventilator to help them breathe while they recover from the infection.
U.S. and European Experts Applaud Creation of New Transatlantic Task Force on Global Antibiotic Resistance Threat
Experts on both sides of the Atlantic applaud President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt, representing the European Union (EU) Presidency, for establishing a transatlantic task force to address antibiotic resistance, an urgent and growing problem that threatens patient safety and public health worldwide.
When should flu trigger a school shutdown?
As flu season approaches, parents around the country are starting to face school closures. But how bad should an influenza outbreak be for a school to shut down?
Initial Results Show Pregnant Women Mount Strong Immune Response To One Dose of 2009 H1N1 Flu Vaccine
Healthy pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine, according to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.
Scientists discover influenza's Achilles heel: Antioxidants
As the nation copes with a shortage of vaccines for H1N1 influenza, a team of Alabama researchers have raised hopes that they have found an Achilles' heel for all strains of the flu-antioxidants.
Important new novel 2009 H1N1 flu advisory for cardiopulmonary transplantation
Each year 3-5 million people have severe cases and 250-500,000 die from complications of seasonal influenza world-wide. This year, the novel 2009 H1N1 (nH1N1) influenza, previously called swine flu, has reached pandemic status.
Paradigm shift needed to combat drug resistance
When people travel, bacteria and other infectious agents travel with them. As about a billion people cross international borders each year, many more billions of the bugs come along for the ride.
Fighting flu: Stricter hand hygiene in schools only a short-term measure
Increased hand hygiene in primary schools is only a short-term measure in preventing infections such as H1N1 from spreading.
Earlier flu viruses provided some immunity to current H1N1 influenza, study shows
University of California, Davis, researchers studying the 2009 H1N1 influenza virus, formerly referred to as "swine flu," have identified a group of immunologically important sites on the virus that are also present in seasonal flu viruses that have been circulating for years.
More H1n1 Influenza Current Events and H1n1 Influenza News Articles
 |
Encyclopedia of Swine Flu (H1N1) and Influenza, 2009: An encyK Resource for Parents, Patients & Professionals by NewsRx (Publisher) Encyclopedia of Swine Flu (H1N1) and Influenza, 2009: An encyK Resource for Parents, Patients & Professionals is a comprehensive compendium of reports on the epidemiology, pathology and incidence of the H1N1 strain of influenza. It contains both up-to-date information on the 2009 outbreak and pandemic, as well as historical perspective on the genetic evolution of the H1N1 mutation and how it may combine with other flu variants to produce a killer virus. Included are reports from the Centers for Disease Control and the World Health Organization, and these organizations' consumer advisories for step to protect against infection. |
 |
Warning Swine Flu Test Subject Keep Back Sign Logo Men's Tee Short Sleeve Size XL White by 99 Volts |
 |
H1N1 and Swine Influenza (Flu) Protection Kit w/ N95 Masks - Meets CDC Guidelines for H1N1 and Swine Flu by JIB EDP Protect against all Influenza's (Flu) Help protect yourself and your family with this Flu Defense Kit. The masks contained in the kit are N95 rated and meet guidelines set forth by the CDC and the Department of Health and Human Services for influenza (flu) protection. In addition to this kit, you MUST: Stay informed. - Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people. - Take everyday actions to stay healthy. -Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it. - Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective. - Avoid touching your eyes, nose or mouth. Germs spread that way. - Stay home... |
 |
CleenFreek SportsHygiene 120-Count Hand and Foot Wipes by CleenFreek CleenFreek wipes address the growing concern among doctors, coaches, athletic trainers, and parents over Staph, and Antibiotic Resistant Staph Infections. Methicillin-resistant staphylococcus aureus (CAMRSA) is affecting athletes at alarming rates. Health clubs, locker rooms and fields of play have become havens for this bacteria. CleenFreek wipes provides patented FDA and EPA registered germ kill technology with first to market (MRSA) kill claims, helping insure prevention and protection for athletes at every level on and off the field. |
 |
60 Minutes - H1N1 (October 18, 2009) Airdate 10/18/09 The H1N1 virus is already setting infection records in this country, and while most people who get this flu can handle it, in some cases, H1N1 can be deadly. Scott Pelley follows the case of 15-year-old Luke Duvall, a high school athlete in intensive care in Little Rock, Arkansas. With staphylococcal pneumonia on top of the H1N1, Luke is on a respirator and fighting for his life. This product is manufactured on demand using DVD-R recordable media. Amazon.com's standard return policy will apply. |
 |
GIANT Microbes Plush Doll Swine Flu (Influenza A virus H1N1) by Giant Microbes This little piggy had swine flu, this little piggy had none. Giant Microbes are stuffed 'animals' that look like tiny microbesonly a million times actual size! Each 5-to-7 inch doll is accompanied by an image of the real microbe it represents, as well as information about the microbe. They make great learning tools for parents and educators, as well as amusing gifts for anyone with a sense of humor! |
 |
2009 Essential Guide to the Swine Flu (H1N1 Influenza A) Pandemic - Vital Plans, Scientific Reports, and Checklists to Help You and Your Organization Prepare for an Influenza Pandemic (Two CD-ROM Set) by U.S. Government (Author) This up-to-date and comprehensive electronic book on two CD-ROM discs provides the best collection available anywhere of official Federal government documents on the vital subject of the new strain of influenza virus discovered in April 2009, the swine flu or H1N1 Influenza A (called Swine-Origin Influenza Virus, S-OIV). In response to an intensifying outbreak in the United States and internationally caused by a new influenza virus of swine origin, the World Health Organization raised the worldwide pandemic alert level to Phase 5 on April 29, 2009. This thoroughly researched collection presents vital information from many authoritative sources: Food and Drug Administration (FDA), Centers for Disease Control (CDC), National Institutes of Health (NIH), NIAID, Health and Human Services... |
 |
Avian Influenza (NCME Video 853) Also With: Network For Continuing Medical Education (Primary Contributor), Alan M. Sanders (Primary Contributor) Global concern about the potential for pandemic avian influenza is rooted in the pathogenicity of avian influenza virus strains in humans and the lack of immunity to these highly mutable viruses in the general population. Avian influenza A (H5N1) re-emerged in 2003 with greater virulence and a wider host range than that seen following its 1997 debut. Although transmission of avian influenza A (H5N1) from animals to humans remains inefficient at this time, mutation or genetic reassortment with human influenza virus strains could trigger an influenza pandemic facilitated by the mobility of modern society and the lack of an effective vaccine. Dr. Alan Sanders provides timely, practical advice on how to improve clinical awareness and implement strategies for diagnosing, treating, and... |
 |
Silverclene24 Flu Virus Disinfectant, Gallon Bottle by Agion SilverClene24TM is a liquid disinfectant and virucide that harnesses the natural protection of silver. SilverClene24 can be used to clean any hard, non porous surface and keep it clean and germ-free for 24 hours. It is even effective against such troublesome microbes as MRSA, VRE, HIV, Influenza, Rhinovirus, Poliovirus, and Trichophyton mentagrophytes (athletes foot fungus). It is EPA registered and safe when used as directed. Non-returnable, all sales final. |
 |
2009 Swine Flu Pandemic Guide - Crucial Survival and Medical Data about H1N1 Influenza A, Drugs, Federal Pandemic Flu Plan - Essential Information for You and Your Family (CD-ROM) by World Influenza News and Report (Author) This up-to-date and comprehensive electronic book on CD-ROM provides the best collection available anywhere of official Federal government documents on the vital subject of the new strain of influenza virus discovered in April 2009, the swine flu or H1N1 Influenza A (called Swine-Origin Influenza Virus, S-OIV). In response to an intensifying outbreak in the United States and internationally caused by a new influenza virus of swine origin, the World Health Organization raised the worldwide pandemic alert level to Phase 5 on April 29, 2009. This thoroughly researched collection presents vital information from many authoritative sources: Food and Drug Administration (FDA), Centers for Disease Control (CDC), National Institutes of Health (NIH), NIAID, Health and Human Services (HHS), Homeland... |
| © 2009 BrightSurf.com |