Volunteer FAQsClick the plus signs for answers.
Why are volunteers needed for AIDS vaccine trials?
AIDS, the disease caused by the human immunodeficiency virus (HIV), shows no signs of diminishing. More than 42 million people worldwide are now infected with HIV. Experts believe that if the rate of new infections does not abate, by 2010, nearly 90 million people will be carriers of HIV. Finding a safe and effective HIV vaccine that will protect people is a formidable task. We cannot do it without the help of volunteers.
What type of volunteers is the HIV Vaccine Trials Network looking for?
We are recruiting healthy, HIV-negative men and women ages 18 and up, who are committed to making a difference in the fight against HIV. Volunteers need to live within the area of the study location for the duration of the trial (at least 12 to 24 months). Please check with the clinic in your area for the cut off age of volunteers as this does differ between sites.
Can I contract HIV or AIDS 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 vaccine, either living or dead. HIV vaccines are safer than those developed from real viruses, such as measles or polio vaccines. They cannot cause HIV or AIDS infection.
What's in the vaccine if it's not HIV?
In general, the vaccines are created from genetically engineered pieces of HIV proteins designed to stimulate a response in your immune system. However, each study tests a different vaccine. If you come in for a screening, the clinic will go over the details of the vaccine, including its components.
What is a vaccine trial?
An AIDS vaccine trial is a study to find out how the vaccine reacts when administered to people. It is a carefully controlled test in which people receive an experimental vaccine to find out if it safe and effective. The experimental vaccines have already been tested on animals and shown to be safe for clinical trials (testing in people). There are three types, or "phases," of vaccine trials that are done with people. Phase I trials are done to study side effects and to see if the vaccine is safe for people to take. If the Phase I trial finds that the drug is well tolerated and seems to stimulate an immune response, a Phase II trial will be conducted. A Phase II trial looks for the most effective dosage, as well as the best vaccination schedule (the time between vaccinations). In a Phase II trial, more people are given the vaccine to see how it works within the immune system and to study safety issues more carefully. Phase III trials test the protective benefits of a vaccine in thousands of people.
What is involved during an AIDS vaccine trial?
You will first be asked some basic eligibility questions to see if you qualify for a trial. If it is determined that you are eligible, you will then go to a screening visit where a clinician will explain the plan for the trial (known as the protocol) in full detail. A brief physical exam, some blood tests, and an HIV test will be done. Each study is different, but a typical trial lasts between 12 and 24 months, requiring an estimated 15-20 visits to the clinic. During the screening you will find out exactly what is involved with your trial. At clinic visits you will be asked questions about your health, any side effects you may have experienced, medications and drugs you are taking.
Who is running the trials?
The trials are being coordinated by the HIV Vaccine Trials Network, funded through the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Click here to visit NIAID's website.
Can pregnant women volunteer in the AIDS vaccine trials?
No. Pregnant women will not be accepted as volunteers, and women who plan pregnancy should postpone it until after the trial. Pregnancy tests are done as part of the screening process and before each immunization. Women of childbearing age must agree to an adequate method of birth control prior to and during the immunization period.
How much blood will be taken from me over the course of the trial?
The total amount of blood drawn over the course of the trial will be less than you would give as a frequent donor through a blood bank.
Do all the volunteers receive an AIDS vaccine in the trial?
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.
Will the vaccine protect me from contracting HIV during the course of the trial?
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 clinic will provide information and counseling on safe sex and on minimizing the risk of HIV infection.
Will my participation in the trial be kept confidential?
Yes, your anonymity will be protected within the limits of the law. No medical information will be released to outside individuals without your written permission. No names are given when reports on trials are made to the scientific community, Food and Drug Administration (FDA) and pharmaceutical companies.
What are some of the possible side effects?
Possible side effects of the experimental vaccines 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.
What are the safeguards?
Safeguards have been built in so that you are told everything that is known about the procedures, including possible risks. No one can take part in a medical study without giving informed consent—reading a description of the actual test and signing a document to show that he or she understands it. You will be given all the facts about what is being done and why, because it's important that you fully understand the procedures. The FDA must approve all vaccine trials before they are tested in humans. The Institutional Review Board at the universities or the Ministry of Health where vaccines are being tested monitors the participation and safety of volunteers. Community representatives, scientists, physicians, ethicists and others make sure participants understand what is involved. The safety and results of the trials are overseen by a Data and Safety Monitoring Board made up of experts in medicine, ethics, statistics, virology, immunology and AIDS clinical research. In addition, Community Advisory Boards of five to ten representatives from the community are associated with each of the sites where vaccines are tested.
How will you know if the AIDS vaccine works?
At this early stage of the vaccine trials (called Phase I or Phase II), we are not testing to see if the vaccines protect anyone against HIV and AIDS. We are testing the vaccines to see how the body responds. The clinics send blood tests to the lab to see if your blood can fight HIV after you are vaccinated. The only way to see if the vaccines actually protect against HIV and AIDS is through a Phase III trial.
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 that defend the body against infection. If you receive an HIV vaccine, you could develop antibodies to the vaccine, causing your HIV test to turn 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 does not mean you are infected with HIV. Your clinic can conduct other tests for HIV that can prove that you do not have HIV. There is no possible way that anyone can contract HIV or AIDS from the vaccine.
Can I donate blood or bone marrow while participating as a volunteer in a trial?
No. Blood banks and bone marrows registries will routinely exclude donors who test HIV antibody positive, for the protection of the recipient.
Could my partner receive my antibodies?
No. The antibodies are not passed on to your partner.
Will it cost me anything to participate in the trial?
The vaccines (or placebos) used in the studies are given free, as well as the tests and exams you receive throughout the trial. A small amount of money is usually given to participants each time they receive the vaccine, or at the trial's end, to offset the costs of participating, for example, bus fare, time off from work, childcare costs, etc.
Will I still need my own doctor?
Yes. Joining a vaccine study is not the same as receiving health care. Even while you are participating in a clinical study, it is very important to maintain regular visits with your doctor. The clinicians at the HIV Vaccine Trials Unit are not responsible for providing primary healthcare, although they will be glad to answer any questions you might have. Your trial clinician will be glad to talk with your regular doctor about your participation in the study.
If I volunteer, is there any way I can change my mind later?
Yes. Although we would like volunteers to be committed to completing the study, you are free to withdraw at any time.
How do I become a participant in a trial and whom can I contact for further information?
Visit the Global Trial Sites page to locate a trial site nearest you.