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 trial 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 trials play an important part in this scientific research.

NO! It is not possible to get HIV from the vaccines, because there is no HIV in them.

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 this trial cannot cause HIV infection.

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, staff will advise you on treatment.

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 test.” The false positive test 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 false positive. There is no possible way that anyone can contract HIV or AIDS from the vaccine.

No. Antibodies cannot be transmitted.

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 trial is over, you and your clinician will find out which you received—the vaccine or placebo.

Taking HIV drugs in an unapproved way can have serious side effects. In addition to making people feel sick, they can also damage the kidneys, liver, bones, or other vital organs when used in an unmonitored fashion. Also, if a person gets infected with HIV while taking PrEP, the HIV may develop resistance to one or more HIV drugs. This could mean that drug options for HIV treatment would be limited. For these reasons and because we don't know whether PrEP can reduce the risk of getting HIV infection, PrEP use is not recommended at this time. Current studies of tenofovir will tell us whether taking daily tenofovir is safe for HIV negative people.

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 trials 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.

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

A typical 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.

Currently we have staff available from 7AM to 5:30PM most weekdays. 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. If you cannot get away at all, then a vaccine study would not work out for you, but a study with shorter appointments might be possible.

Trial 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 trial 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, every study location works with a location Institutional Review Board, sometimes called an Ethics Committee, that reviews all of the details of the trial. 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 they join the trial, volunteers are provided with information about HIV and AIDS, about the reasons for the trial, about possible risks and benefits, and about trial procedures. Clinic staff 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.

After the trial has been fully explained, volunteers are asked to sign an informed consent form before enrolling. This form will help to make sure that participants have been given all the information they need. Volunteers will be given plenty of time to consider whether or not they want to join the trial. They may decide not to join the study. If they do enroll, they may still leave the trial at any time without losing the benefits of their standard medical care or any other services provided at that location.

During the trial, clinic staff will monitor participants to make sure the investigational vaccine is not causing problems. Throughout the trial, any new information researchers learn about the safety of the study vaccine will be given to participants. Participants will be able to decide whether or not to stay in the study based on any new information they learn.

Participants are reminded frequently that being part of a vaccine trial does not mean they are protected from HIV infection. They are counseled at each clinic visit on ways to avoid HIV infection (for example, correct and consistent condom use).

Based on the data from animal studies and earlier trials in people, scientists believe that the investigational vaccine is safe enough to use in this trial. One purpose of this trial is to get more information about the safety of the investigational vaccine.

Previous studies have tested the investigational vaccine in more than 250 people, more than 60 of whom were given the investigational vaccine at the same dose or higher than the dose used in this trial. Two similar HIV vaccines have been tested in more than 450 people.

Before being given to people, the investigational vaccine was tested in mice, rabbits, and monkeys.

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

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

Several groups monitor this trial for safety and to 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 and local Institutional Review Boards (also called Ethics Committees).

Physicians on the team that designed the Step Study will monitor the safety of the trial. This team carefully considered all of the available information to decide that the investigational vaccine was safe enough to study in this trial.

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 trial participants. If there are safety concerns, the DSMB can recommend that the trial be changed or stopped.

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

Participating in a trial may also restrict the volunteer's behavior. For instance, participants are asked not to donate blood, and women should not get pregnant during the trial.

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 a trial.

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

It is important to remember that being given the study vaccine does not mean the participant is 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. Trial participants also will not know whether they have gotten the study vaccine or the placebo, which is an inactive substance (saline solution) that does not provide any protection. Participants are counseled at every clinic visit to avoid behavior that will put them at risk of HIV infection.

To help avoid problems that could come from participating in a trial, participants 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.

Our studies last at least 12 months and we will not be able to enroll you. However, check out the HVTN website and see if there’s a study site in your new location.

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 trial.

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 counseled to avoid behavior that would put them at risk of HIV infection. Those who become infected during the trial will stop receiving injections, but clinic staff will ask to continue monitoring their health for the rest of their scheduled time in the trial, 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 trial. Participants who become infected during the trial will be referred to an appropriate doctor or medical agency for medical care, including antiretroviral therapy, and counseling.

The trial will be run by the pharmaceutical company that developed the vaccine and by the 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 trials 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).

The study vaccine is 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 trial also carefully reviewed the information about the investigational vaccine before deciding to begin the trial.

The trial 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 in the Step Study are monitored by Institutional Biosafety Committees (IBC) and Institutional Review Boards (IRB) at to each research center. Community members are involved throughout the trial to ensure that the rights and needs of participants are being met.

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

About AIDS vaccine clinical trials: AIDS Clinical Trials Information Service, 1-800-TRIALS-A (USA only); www.clinicaltrials.gov