Flu Vaccine Trials FAQ
These are some questions and answers about the H1N1 (swine) flu vaccine testing at Group Health Center for Health Studies.
How was the vaccine developed?
The U.S. Centers for Disease Control and Prevention (CDC) isolated and characterized the H1N1 virus. Then they produced and distributed a 2009 H1N1 seed virus to manufacturers. From this, the manufacturers developed vaccine pilot lots for testing in clinical trials.
Now the federally funded Vaccine and Treatment Evaluation Units (VTEUs) are evaluating these pilot vaccines for safety and testing whether they help people develop immunity to the H1N1 virus.
Like the regular seasonal flu vaccines, the new H1N1 flu vaccines the VTEUs are testing do not contain the whole virus. To make the vaccine, the virus is killed and then broken up, so the injection contains only certain parts of the virus. It's possible that the vaccines may cause side effects, such as arm pain or swelling at the injection site or possibly other reactions. But participants cannot get the flu from the vaccine.
What questions are the Seattle scientists trying to answer with this first trial?
In this first trial, they want to learn:
If preliminary data show that the vaccines are safe in healthy adults and healthy elderly people, similar trials in children aged 6 months to 17 years will begin.
Additional trials may look at other questions such as whether the flu vaccine can be administered safely at the same time as the seasonal flu vaccine or before or after it.
How will the safety of the volunteers in these trials be ensured?
The VTEU study teams will closely monitor the health status of all volunteers for any adverse side effects. A panel of outside experts will also conduct an ongoing, close review of the safety data from these trials to spot any safety concerns in real time.
How will the results be used?
Information from these studies in healthy people will help public health officials develop recommendations for immunization schedules, including the best dosage and number of doses for various age groups.
Data from these trials may also support decisions about immunizations for people in high-risk groups. These groups include: pregnant women and people with underlying medical conditions, such as HIV, asthma, and diabetes.
How is this first study being conducted?
All study participants will receive two doses of the vaccine three weeks apart. Blood tests three weeks after each vaccination will measure antibodies to the virus. The responses after one dose versus two doses will be compared.
Blood samples will also be collected a little over one week after vaccination to check for any early indications that some individuals may have a primed immune system that's already immune to the H1N1 virus.
The researchers will compare the responses among people in different age groups. This may help to determine if older adults have some immunity to the new H1N1 virus, possibly from exposure to similar flu viruses in the past.
When will the results of the trial be available?
Preliminary results from a subset of study participants are expected a few weeks after the trials begin.
How many people does the Seattle VTEU need to recruit for this study?
The Seattle VTEU aims to enroll 268 of the 400 adult volunteers needed nationally. Half of these will be recruited at Group Health and half at UW. If a similar study is to be conducted in children, Seattle Children's Research Institute aims to enroll 120 of the 600 children needed nationwide.
How is volunteer recruitment going?
The response to news coverage of the study has been encouraging. More than 1,000 people have called to volunteer. The study team is currently screening volunteers to find out if they are eligible for the study.
Who qualifies for the study?
Generally, healthy adults of all ages are needed. More specific criteria are available at www.clinicaltrials.gov.
The study involves five visits to the Group Health research facility in downtown Seattle or the University of Washington (UW) Virology Clinic near Harborview Medical Center.
What motivates people to be in the study?
The H1N1 flu virus has the potential to cause significant illness worldwide this fall and winter. Many volunteers say they want to help find the best ways to prevent the spread of the flu and protect the health of people in our community and around the globe.
What should people do if they want to volunteer for the studies?
For more information about vaccine trials for people aged 18 and older, call Group Health Center for Health Studies at 206-287-2061 or toll free at 1-866-883-6772. Or call the UW Virology Clinic at 206-720-4340. For information about vaccine trials for those aged 17 and younger, call Seattle Children's Research Institute at 206-884-1100.
How are the VTEUs and their research funded?
The National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, funds them and their research.
Which 2009 H1N1 influenza vaccines are being tested in the VTEU trials, and why were these two vaccines chosen?
The initial VTEU trial will be testing two candidate 2009 H1N1 influenza vaccines: one made by Sanofi Pasteur (Swiftwater, Penn.) and the other by CSL Limited (Melbourne, Australia). This first trial at Group Health and UW will look at the CSL Limited vaccine.
These two vaccines were first chosen for the VTEU trials based on Department of Health and Human Services (HHS) projections of their initial availability and the need to determine as quickly as possible if vaccines without adjuvant (a substance added to boost immunity) could induce potentially protective immune responses. In addition, seasonal flu vaccine made by Sanofi Pasteur is currently licensed in the United States for use in children, which meant that a candidate H1N1 influenza vaccine made by the company could be tested in U.S. children. Both vaccines also are available in versions made without thimerosal, a mercury-based preservative. Other candidate H1N1 influenza vaccines may be tested in future VTEU trials.
How do these trials relate to the trials the manufacturers are conducting?
The five manufacturers who already produce U.S.-licensed seasonal vaccine are conducting their own 2009 H1N1 influenza vaccine trials under contract with the HHS. The VTEU trials are intended to generate clinical data that may be used to inform policy decisions likely to affect how the vaccines are given. For example, the NIAID-supported VTEU trials may evaluate the vaccines in some populations (like children) that manufacturers are not planning to study. The trials are also intended to generate data that are outside a company's clinical development plan but that may be needed to support licensure or use of the vaccine in special populations or under an Emergency Use Authorization. The Food and Drug Administration may issue such an authorization to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.
How can I get more information about the trials at Group Health?
More details about the Group Health CHS study:
What are the VTEUs?
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.
Where are the eight VTEUs?
Some of the VTEUs have subsites helping them to conduct the trials. Group Health's subsites are the UW and Seattle Children's Research Institute. Co-investigators for the Group Health Cooperative VTEU are Dr. Anna Wald, professor in UW's Department of Medicine, Epidemiology, and Laboratory Medicine; and Dr. Janet Englund, professor of pediatrics in the Department of Infectious Diseases at Seattle Children's Research Institute. In addition to serving as senior investigator at Group Health Center for Health Studies, the Seattle VTEU's Principal Investigator Dr. Lisa Jackson is a professor in epidemiology at UW, with an adjunct appointment in the Department of Medicine.