Most studies are about one year long. There may be 1 to 4 injections and about 7 to 14 clinic visits depending upon the study plan. Screening and injection visits can take up to four hours. All other visits are usually under an hour.
Research study visits are at the Vaccine Research Center (VRC) Clinic at the National Institutes of Health in Bethesda, Maryland. Free valet parking is available. You can also get there by Metro. Take the Red Line, and get off at the Medical Center Metro Station. Clinic hours are Monday through Friday from 8:00 a.m. to 4:30 p.m. We can usually schedule clinic visits at other times, but we cannot conduct visits on holidays or weekends.
Please call the Vaccine Research Center toll-free at 866-833-LIFE (5433), email us at email@example.com. We are looking for healthy volunteers 18 to 60 years old. We will ask you a few questions about your health. If you meet certain criteria, we will set up a screening visit. At this visit we will do a complete physical exam and blood work to see if you are eligible to participate in a vaccine clinic trial.
You might have short-term side effects, similar to those from any vaccination, such as arm soreness or feeling tired or unwell. Since these are the first studies of the vaccines in people, there may be risks or side effects that are not known. We will discuss potential side effects with you before you enroll.
You cannot donate blood, blood products such as platelets, or bone marrow during participation in the research study. In addition, blood banks will not accept donations for one year after the last dose of an investigational vaccine. Also, please do not donate blood six weeks before you come in for screening.
Yes, volunteers are compensated for travel expenses and time lost from work. These payments are not likely to fully cover your real costs, however. Payments are made after each visit. Most studies offer about $200 for vaccination visits and $175 for most other visits, but compensation varies by study.
If you move out of the area within the first few months of starting a study, we may not be able to monitor you adequately. When you contact a VRC staff member, please discuss with us any relocation or extended travel plans.
Protocol Specific FAQs: Preventive HIV Vaccine Development
No. You cannot get an HIV infection from the vaccine. In this investigational vaccine, scientists created synthetic (man-made) genes. These synthetic genes are designed to make proteins that resemble those present in a real virus. They do not contain the information required to cause HIV infection. Proteins in the vaccine are present for a short time before being broken down by the body. These proteins are look-alikes, are not live, so they cannot cause HIV. There is no virus or infected material in the investigational vaccine, so there is no way that it can cause HIV/AIDS.
The vaccine is designed to work by mimicking the shapes and structures of HIV proteins. They cause the immune system to produce antibodies and lymphocyte responses that may recognize and attack HIV. In this way the immune system may be educated to recognize and potentially respond quickly if you were to encounter HIV. The hope is that the body's natural immunity prepared by vaccination will be able to fight off a real HIV exposure. Please remember that this is an investigational vaccine. We don't know if it works, and extensive testing will be needed to eventually answer this question. [Adenovirus specific]: This vaccine is part of a generation of vaccines called "vaccine vectors." A vector is a packaging system that can help deliver the vaccine more effectively into the right part of the body or into the right cell, in order to produce the best possible immune responses. In this study, an adenovirus vector carries synthetic genes into human cells. The adenovirus shell protects the vaccine genes until they are in a cell that can produce the vaccine protein. The adenovirus cannot reproduce, cause infection, or damage the immune system, and the HIV genes cannot produce infection or reassemble to make a virus.
To be eligible for a study, you must be HIV negative. Some investigational vaccines may be strong enough to cause an antibody response detectable on standard HIV tests. These tests measure the body's antibody response to HIV and do not directly measure HIV itself. Therefore, having a false-positive antibody test for HIV after vaccination is not unexpected. It does not mean you are infected. At every visit, we perform specialized testing to prove that you are not HIV infected. No medical side effects or problems are associated with having a false-positive antibody test. Remember, this vaccine contains no live virus, so you cannot be infected with HIV or develop AIDS from this vaccine.
No. There is no evidence that this investigational vaccine will protect you from getting HIV infection. The main purpose of this study is to test whether the investigational vaccine is safe. You should avoid high-risk behavior that would put you at risk for HIV infection.
No. This vaccine is not made from live virus or HIV infected cells. There is no possibility that it contains live or killed HIV; therefore, it is impossible to be infected with HIV or develop AIDS from the vaccine.
Certain times after receiving each injection, specialized laboratory testing will be done on your blood to see if your immune system responds to the vaccine. The results of these tests will be evaluated and compared to what we have learned about vaccine-induced protective responses in animal studies. We will not expose you to the virus at any time and ask that you avoid any risk that may cause you to be exposed to the virus. Specific counseling will be available to help you stay HIV uninfected during the trial. This vaccine is part of a global effort to create a safe, effective vaccine for HIV. After trials are completed at this site, our vaccine will be placed into expanded clinical trials in the United States and around the world. Eventually large trials will be done to see if the vaccine can reduce the rate of HIV infection.
Protocol Specific FAQs: Seasonal Influenza Vaccine Development
Seasonal influenza refers to the infection commonly called "the flu". It is caused by the influenza virus. In the United States, seasonal influenza tends to occur from October through March. The flu causes symptoms including fever and severe malaise, as well as muscle aches, headache, and cough. The term pandemic influenza is used when a new strain of influenza virus infects a very large number of people.
No. You cannot get the flu from the vaccines being studied at the VRC. The investigational vaccine has synthetic (man-made) genes that allow your body’s cells to make proteins similar to those in influenza virus. After your body makes the proteins, they are only present for a short time before being broken down. There is no influenza virus in the investigational vaccines. It is not possible for them to cause any type of infection or spread infection to others. You also cannot get the flu from the licensed influenza vaccine being studied at the VRC. We will not expose you to influenza virus at any time.
The vaccine contains the genetic information or genetic instructions for seasonal influenza proteins. After vaccination, the body should make seasonal influenza proteins for a short time. The immune system should then make antibodies and other immune responses to these proteins. Please remember that the vaccines are investigational. We don’t know if they work. The first studies are to see if the vaccines are safe. More testing will be needed to see if the investigational vaccines can help prevent seasonal influenza infection.
You might have short-term side effects, such as arm soreness or feeling tired or unwell. Since these are the first studies of the vaccines in people, there may be risks or side effects that are not known. We will discuss potential side effects with you before you enroll.
The main purpose of this research study is to test whether the investigational vaccine is safe and well tolerated. Another goal of the study is to see if the investigational seasonal influenza vaccine "boosts" or increases the body's immune response to the licensed vaccine. This study will also help us develop a plan to investigate what combination of vaccines (prime-boost regimen) provides better protection against seasonal influenza virus.
Since evaluation of the investigational vaccine is just beginning, we do not know whether or not it will work. During a study, blood samples are collected and laboratory tests are done on those samples to see if your immune system responds to the vaccine. The results of these blood tests will be compared to the kind of immune responses seen in animal studies. As a part of the study, you will receive the licensed seasonal influenza vaccine. As is true every year with the licensed influenza vaccination, you should not assume guaranteed protection from seasonal influenza.
Please call the Vaccine Research Center toll-free at 866-833-LIFE (5433), or email us at firstname.lastname@example.org. We are looking for healthy volunteers 18 to 70 years old. We will ask you a few questions about your health. If you meet certain criteria, we will set up a screening visit. At this visit we will do a complete physical exam and blood work to see if you are eligible to participate in a vaccine clinic trial.
Protocol Specific FAQs: Ebola Vaccine Development
No. You cannot get Ebola infection from the vaccines being studied at the VRC. Scientists use synthetic (man-made) genes in developing the investigational vaccines. These synthetic genes allow the body's cells to make proteins similar to those in a real virus but they do not have the genetic information needed for Ebola infection. The proteins coded for by the vaccine that are made by the body are only present for a short time before being broken down. There is no Ebola virus in the investigational vaccines, so it is not possible for them to cause Ebola infection.
The vaccine DNA codes for Ebola proteins. After injection, the body should make Ebola proteins for a short time. If this happens, the immune system will be able to make antibodies and cellular immune responses to these proteins. In this way the immune system may recognize and respond quickly to Ebola in the future. Please remember that the vaccines are investigational. We don't know if they work. The first studies are to see if the vaccines are safe. More testing will be needed eventually to see if vaccinations can prevent Ebola infection.
The main purpose of this research study is to test whether the investigational vaccine is safe and well tolerated. Since the VRC is studying the new investigational vaccine for the first time, there is no evidence about whether or not it will work. During a study blood samples are collected at certain times after each injection is given. Laboratory tests will be done on your blood samples to see if your immune system responds to the vaccine. The results of these blood tests will be compared to the kind of immune responses seen in studies where a vaccine protected animals from infection with the Ebola virus. We will not expose you to the Ebola virus at any time. This study will also help us develop a plan of future investigation in order to learn whether vaccination against Ebola virus works.
No. The VRC Ebola vaccines are not made from live virus or Ebola infected cells. We will not expose you to the Ebola virus at any time. You cannot spread Ebola virus from the vaccine.
The human immune system is complicated. Different kinds of vaccines cause different kinds of immune responses. Studying more than one vaccine type allows us to compare responses. Also, we can see if using a schedule that includes more than one type of investigational vaccine might give a better response than a schedule that includes only one type of vaccine.
If you have a question about a particular VRC clinical trial and it isn't answered here or elsewhere on our website, please contact us via email at email@example.com or call 866-833-LIFE (5433).