HIV Vaccine Trials Unit - University of Rochester

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Who can participate in this study in Rochester?

We are in search of healthy, HIV-negative male and female volunteers ages 18-50. See our Sign Up, Help Out section for more information.

Will I receive compensation?

Yes, you will receive compensation for your time and travel. Compensation is typically $750 presented over the course of the study.

Who should I contact if I want to know more about this study?

We encourage potential volunteers to visit the Sign Up, Help Out section and make use of the eligibility questionaire. Please follow the link where you can find more information. For complete information or to join the trial, contact us at 585-273-2437 or 756-2329 (756-2DAY) or hvtu_cer@urmc.rochester.edu.

What is HIV?

Human Immunodeficiency Virus is the virus that causes AIDS (Acquired Immunodeficiency Syndrome). HIV harms the body's immune system by attacking certain kinds of cells, known as helper T cells or CD4 cells, which defend the body against illness.

What is AIDS?

AIDS occurs when an individual’s immune system is weakened by HIV to the point where they develop any number of diseases or cancers. It is measured by a T-cell count of 200, or below.

What is the difference between HIV and AIDS?

HIV is the virus that causes AIDS, the most advanced stage of HIV disease. A weakened immune system caused by HIV will allow opportunistic infections (OIs) to develop. A healthy immune system would normally fight these infections while an HIV-weakened immune system is susceptible.

How does someone get HIV?

In the United States, most people get HIV through unprotected sex, including vaginal, anal and oral sex, and through injection drug use. Certain bodily fluids including blood, pre-cum, semen, and vaginal secretions, spread HIV. An HIV infected woman can pass HIV to her baby through pregnancy or delivery, and also through breast milk. According to the U.S. Centers for Disease Control and Prevention (CDC), contact with saliva, tears, or sweat has never resulted in someone getting HIV. You cannot get HIV through casual contact such as hugging or shaking hands.

Is there a cure or vaccine for HIV/AIDS?

At this time there is no cure or vaccine for HIV. However, there are new treatments available that have been found to be highly effective in keeping people healthy longer and in delaying the onset of AIDS.

Is there a link between HIV and other STDs?

According to the Centers for Disease Control and Prevention (CDC), people with other STDs are more likely to become infected with HIV. Having STDs that can cause open sores, such as herpes, is especially risky. STDs that do not cause open sores also pose a threat.

Could I be infected with HIV by this vaccine?

No, you cannot. The vaccines only include genetically engineered pieces of HIV proteins, designed to stimulate a response in your immune system. There is no whole HIV virus, either live or killed, used to make the vaccines. No one can be infected with HIV by the vaccine.

What is a vaccine trial?

An HIV vaccine clinical trial is a research study designed to find out how the vaccine works when given to people. It is a carefully controlled test in which people receive an experimental vaccine to find out if it is well tolerated and how it stimulates the immune system. For more information visit the vaccine research section.

Are these vaccines safe?

The research HIV vaccine studies that have been tested to date demonstrated they were safe for the thousands of persons in total who participated in those studies. The effects of new vaccines being researched can not be fully understood until the studies are completed. Vaccines might produce a redness and/or soreness at the injection site, or perhaps mild flu-like symptoms. These side effects can occur whether you receive the vaccine or a placebo, a substance which does not contain the vaccine component.

Will the vaccine I receive protect me against HIV infection?

No. There is, as yet, no vaccine to prevent HIV infection. That's what these trials are all about. Since all the investigational vaccines are still being studied, you must practice the safest behavior possible.

Does everyone in the study receive vaccine?

No. To have a true, controlled comparison, some of the participants are given a placebo, an inactive substance or substitute, instead of the vaccine. You will not know whether you have received the vaccine or a placebo until the end of the trial.

Will I know what vaccine I am receiving?

Only at the end of the study will you find out. During your screening visit, you'll be told about what specific vaccine or vaccines are being tested in the study. Neither you nor your clinicians 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, you and your clinicians are told which vaccine you received or if you received a placebo. You may not be able to participate in further vaccine studies. You may also be asked to be involved in follow-up studies.

How long do these studies last?

Generally these studies last about 12-18 months, but may last longer. Your research nurse will be able to tell you specifically how long your study will last.

How do I enroll in a study?

When you call the clinic to see if you qualify for the trial, you will be asked some basic eligibility questions and you will be asked to come in to the clinic for a couple of information sharing meeting. If it appears you qualify and remain interested throughout the screening visits, the clinician will explain the study to you in detail. A brief physical exam, some blood tests, and an HIV test are done. You'll be asked detailed questions about your health and your sexual behavior. During the interviews, ask as many questions as you wish. During this process you may be asked to sign several consent forms for research purposes. If you’re eligible and you decide to join a study, you’ll be invited to schedule your first vaccination visit.

What is Informed Consent?

Informed Consent is an ongoing process to keep you informed about the particular study you are interested in. It ensures that after being informed of all the risks of the study and your responsibilities you agree to enroll. In the process, you will be asked to sign a consent form. Be sure that you understand and agree with everything about the study before you sign this form. We’ll give you a copy to keep.

Joining a vaccine study means that you agree to meet the schedule and requirements of the study. If you don't feel comfortable with this, or if you can't make all the appointments, talk to the people running the trial. Perhaps they can be flexible, or together you may decide that you cannot participate in the study.

You may discontinue your participation in the study at any time. It is important to understand that the researchers plan their trials around the participants; test results can lose their meaning when volunteers drop out. If you think you might drop out for any reason, it would be better not to enroll.

Will it cost me anything?

The vaccines (or placebo) used in the studies are given free so are 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, to offset the costs of participating (for example: bus fare, time off from work, or childcare costs).

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.

Who protects me while I am in the trial?

Every institution that conducts medical research involving people as volunteers is required by the federal government to have an Institutional Review Board, or IRB. The IRB is a group of people from various professions who protect the rights of people in a trial. The board reviews the trial on a regular basis. A Community Advisory Board made up of volunteers and interested individuals outside the studies are also involved in the protocol review process.

Who is in charge of the trial?

The National Institutes of Health sponsors these studies, however, at every clinic site there is a "principal investigator." This person is typically a physician who has many years of experience conducting clinical trials. Other clinical staff such as physicians, nurses and nurse practitioners perform exams, take blood, answer questions, and vaccinate and interview you.

Why join a study?

All kinds of people have volunteered for the HIV vaccine trials--ages 18-60, all sexual orientations, all races, male and female. There may be no direct benefit to a volunteer in an HIV vaccine study. However, most people volunteer because it gives them an opportunity to directly fight the AIDS epidemic. Some people volunteer because they have a loved one who is living with or has died of AIDS and they want to do their part. Each reason is a very personal one and there is no right reason to join.

How do I finally decide?

Get the facts. Talk to a clinician to see what will happen during the trial, and what is expected of you. We can try to arrange a confidential phone conversation between you and a trial participant, so you can ask them questions about their participation.

Talk with your regular healthcare provider about the study and encourage them to call the study site if they don't know about the vaccine research effort in Rochester. Think it over. And don't join a study until you are comfortable with all you've learned.