Frequently Asked Questions for Vaccine Studies

plus  What is a vaccine study?

A vaccine is given to prevent infection or fight disease. Currently there is no vaccine against HIV. Part of the process of finding an HIV vaccine is testing study vaccines that seem most likely to help the body fight HIV. A vaccine study is a standard way to test a specific study vaccine so that researchers can prove that the study vaccine is safe, and can find out more about whether it might work to prevent or fight disease. Volunteers who participate in HIV vaccine studys play an important part in this scientific research.

plus  Can I get HIV from the vaccine?

NO! There is no way to contract HIV or AIDS from the vaccine. Because the vaccines are man made, there is no HIV in the vaccines either living or dead.

plus  Can a study vaccine cause HIV infection?

It is impossible to get HIV infection or develop AIDS from experimental vaccines. They are not made from live HIV, killed HIV, weakened HIV, or HIV-infected cells. The investigational vaccine in our studys cannot cause HIV infection.

plus  What are the side-effects?

Possible side effects of the injections could include fever, chills, rash, aches and pains, nausea, headache, dizziness, and fatigue. Injections can cause pain, soreness, redness, and swelling on the part of the body where you receive the vaccine shot. The side effects usually do not last long and participants usually do not need any form of treatment. However, if necessary, a clinician will advise you on treatment.

plus  Will I test HIV positive as a result of the vaccine?

The most common test for HIV is an antibody test. Antibodies are proteins in the blood, made by your body to try to defend itself against infection. If you receive an HIV vaccine, you could develop antibodies to the vaccine, so your HIV test could turn up antibody positive even though you are not infected. This is called a “false positive” or ”Vaccine Induced Seropositive“ or "VISP." VISP does NOT happen to everyone who receives a vaccine. It also does not mean you are infected. There are other tests for HIV that can prove that you do not have HIV and we would do these tests in our clinic to help you avoid any problems or misunderstandings from testing VISP. There is NO possible way that anyone can contract HIV or AIDS from the vaccine.

plus  Could my partner receive my antibodies?

No. Antibodies cannot be transmitted.

plus  Does everyone get an HIV vaccine in a vaccine study?

Some people don't. To have a true, controlled comparison, some of the participants are given a placebo, an inactive substance or substitute, instead of the vaccine. You can't choose which you are given. Neither you nor your clinician will know whether you receive a vaccine or a placebo. This is called a "double blind" study design and guarantees that all participants are studied and followed in exactly the same way. After the study is over, you and your clinician will find out which you received—the vaccine or placebo.

open  Will the vaccine protect me against HIV?

No. It is not known whether any of the experimental vaccines will protect you against HIV. It is important for you to maintain a low risk of HIV infection. Your clinician will provide information and counseling on safe sex and on minimizing the risk of HIV infection.

plus  Who is eligible to participate in a study?

We are looking for healthy men and women, ages 18-50, who are committed to making a difference in the fight against HIV. Volunteers for vaccine studys should be HIV negative and planning to stay in the Seattle area for the duration of the study (at least 12-24 months).

An important goal at our clinic is diversity. People of different backgrounds may respond differently to a vaccine and we need to make sure we find an HIV vaccine that will work well for everybody.

plus  If I volunteer, is there anyway I can change my mind later?

Although we would like our volunteers to be committed to completing the study, you are free to withdraw from the study at any time.

plus  What is a study like?

A typical vaccine study lasts 12-24 months. You would go to one or two screening visits to learn more about the program and find out whether you are eligible to join. If you join, you would be vaccinated approximately 3-6 times during the study. You would also come to the clinic for about 7-10 other visits for checkups and blood draws. Vaccine visits usually take about 90 minutes and checkups are about 30 minutes. You will usually be seeing the same clinician (nurse or doctor) most of the time during the study. You would be tested for HIV several times during the study. We would also regularly ask you questions about your health, medications and drugs you are taking, and your risks for HIV infection.

plus  I work from 8AM to 6PM and I can’t get off work. Do you have Saturday appointments or evening appointments?

Currently we have staff available from 7AM to 5:30PM most weekdays and on Wednesdays we are in from 7AM to 8PM. We are closed on Saturdays and Sundays. You would need to be able to have a few 90-minute appointments for vaccination visits. If you can get in to work at 8:30 AM a few times a year or leave work early at 4PM or take an extended lunch break, you might be able to join.

plus  How will the safety and rights of participants be protected?

Study participants play a very important role in the search for an HIV vaccine, and the safety and rights of participants are given the highest priority. This study meets international standards for ethical research that were created by the Helsinki Declaration of the World Medical Association and Council for International Organizations of Medical Sciences (CIOMS) guidelines.

During the study, all of the data is reviewed by a Safety Monitoring Board. This group of experts can stop the study at any time if they feel that the risks for participants are too great.

In addition, our study location works with Fred Hutchinson Cancer Research Institutional Review Board (IRB), sometimes called an Ethics Committee, that reviews all of the details of the study. These groups also make certain that the rights of participants are protected.

It is important for participants to know that any new study vaccine may have both medical and non-medical risks, and there may be additional risks that we do not know about yet.

Before you join a study, volunteers are provided with information about HIV and AIDS, about the reasons for the study, about possible risks and benefits, and about study procedures. Clinic staff will allow plenty of time to talk with volunteers and answer their questions, and information is also provided in writing.

For more information on participants' rights and responsibilites, visit www.hvtn.org/community/rights.html.

plus  How do I join a study?

First, call us at 206.667.2300 so we may ask you a few simple questions and schedule a screening.
After the study has been fully explained, you will be asked to sign an informed consent form before enrolling. This form will help to make sure that you have been given all the information you need. You will be given plenty of time to consider whether or not you want to join the study. You may decide not to join the study. If you do enroll, you may still leave the study at any time without losing the benefits of your standard medical care or any other services provided at our location.

During the study, clinicians will monitor you to make sure the study vaccine is not causing problems. Throughout the study, any new information researchers learn about the safety of the study vaccine will be given to participants. You will be able to decide whether or not to stay in the study based on any new information we learn.

You will be reminded frequently that being part of a vaccine study does not mean you are protected from HIV infection. You will be offered counseling at each clinic visit on ways to avoid HIV infection (for example, correct and consistent condom use).

plus  Is an investigational vaccine safe?

Based on the data from animal studies and earlier studys in people, scientists believe that the investigational vaccines are safe enough to use for research. One goal of our research is to get more information about the safety of investigational vaccines.

Many studies have previous tested some of the investigational vaccines in more than 1000 people, many of whom were given the investigational vaccines at the same dose or higher than the dose used in a study you may be in.

Before being given to people, investigational vaccines are tested in mice, rabbits, and monkeys.

While scientists believe that there are no serious safety risks with the investigational vaccines, there is always the possibility that there could be problems that no one expected. This is why investigational vaccines, like any new drug or vaccine, need to be tested in participants in a controlled clinical setting. Participants' health and safety will be closely monitored throughout the study.

Because investigational vaccines do not contain live HIV virus, there is no way for the study vaccine to cause HIV infection.

plus  How is the safety of an investigational vaccine monitored?

Several groups monitor our studies for safety and make certain the study is being conducted according to scientific and ethical standards. These groups include the US Food and Drug Administration (FDA), the US National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN), Fred Hutchinson Cancer Research Center's Institutional Review Board and our own Community Advisory Board (CAB).

In addition, there will be an independent Data and Safety Monitoring Board (DSMB). A DSMB is a group of experts that are not part of the HVTN, or the researchers, who will carefully monitor the safety of the study participants. If there are safety concerns, the DSMB can recommend that the study be changed or stopped.

plus  Are there non-medical (social) risks?

You will be asked to carefully consider all risks before joining a study. Some risks are medical, but there are also social risks. Study participation takes time and commitment. It may also lead to complications with others who do not agree with the participant's choice to join the study, or who do not have enough information about HIV vaccine research. For example, some people have reported that being in a study has upset their partner, spouse, friends or family members.

Participating in a study may also restrict the your behavior. For instance, you will be asked not to donate blood, and women should not get pregnant during the study.

Some people have experienced discrimination when they told people they were participating in clinical research for an HIV vaccine. In the case of discrimination, study staff can (at a participant's request and with their permission) talk to insurance companies, employers, and others to explain a participant's involvement in the research.

An investigational HIV vaccine could cause a false positive result on a standard HIV test, and such a result may lead to being treated unfairly by others. This will be explained to you in more detial during the informed consent process.

It is important to remember that being given the study vaccine does not mean you are protected from HIV infection that is due to sexual contact, sharing of injection drug equipment, or any other transfer of blood or bodily fluids. We still do not know if this study vaccine protects against infection. You will also not know whether you have gotten the study vaccine or the placebo, which is an inactive substance (saline solution) that does not provide any protection. You will be offered counseling at every clinic visit to avoid behavior that will put you at risk of HIV infection.

To help avoid problems that could come from participating in a study, you will be offered an identification card that shows that they have joined an HIV vaccine study. A telephone number will be listed on the card that may be called for information or for help in resolving problems.

plus  I am going to move out of the Seattle area in five months. Can I still join?

Our studies last at least 12 months and we will not be able to enroll you unless there is a study site where you are moving to. Check out the HVTN website and see if there’s a study site in your new location.

plus  What will happen to participants if they become HIV-infected from their behavior during a study?

While the investigational vaccine cannot cause HIV infection there is no guarantee that the investigational vaccine will prevent HIV infection. All participants must be HIV negative when they enroll in the study.

It's important to note that participants can still get infected with HIV through sexual contact, sharing of injection drug equipment, or any other exchange of blood or bodily fluids, even if they are receiving the study vaccine.

Participants are offered counseling to avoid behavior that would put them at risk of HIV infection. Those who become infected during the study will stop receiving injections, but clinic staff will ask to continue monitoring their health for the rest of their scheduled time in the study, and the researchers will test their blood to see how the body fights the HIV infection.

There are many drugs that can be used to treat HIV infection, but none of these drugs can cure HIV infection. These drugs are not provided as part of this study. Participants who become infected during the study will be referred to an appropriate doctor or medical agency for medical care, including antiretroviral therapy, and counseling.

plus  Who is conducting the studies?

The study will be conducted by the Seattle HIV Vaccine Trials Unit and HIV Vaccine Trials Network (HVTN).

The HVTN is a global partnership of researchers, governments, pharmaceutical companies, academic institutions, and community members. The HVTN is dedicated to conducting international clinical HIV vaccine studys in the safest, most efficient way possible. The HVTN is funded and supported by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), an agency of the US Department of Health and Human Services (DHHS).

plus  Who reviewed and approved the studies?

Our study vaccines are considered experimental, meaning that the FDA allows its use only in research studies. It has been manufactured according to FDA guidelines and was reviewed by the FDA. The protocol team (the people from the HVTN, the pharmaceutical companies, and DAIDS) who designed the study also carefully reviewed the information about the investigational vaccine before deciding to begin the study.

The study has also been reviewed by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The safety and rights of participants may also be monitored by our Institutional Biosafety Committee (IBC) and Institutional Review Board (IRB). Community members are involved throughout the study to ensure that the rights and needs of participants are being met.

plus  For more information

About the HIV Vaccine studys Network: www.hvtn.org

About AIDS vaccine clinical studys: AIDS Clinical studys Information Service, 1-800-studyS-A (USA only); www.clinicalstudys.gov

 
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