WHAT IS A VACCINE?
A vaccine is a medical product (substance), usually given by injection or orally, to protect individuals from getting a disease.

WHAT IS A VACCINE TRIAL?
A vaccine trial is a carefully controlled experiment in which people are given a vaccine to find out if it works and is safe.  Vaccine trials may also be called vaccine studies.

WHAT IS THE PURPOSE OF AN HIV VACCINE TRIAL?
The purpose of an HIV vaccine trial is to test the vaccine material to determine if it is safe and can prevent HIV, the virus that causes AIDS.

WHO APPROVES THE TESTING OF THE VACCINE IN UGANDA?
The National Council of Science and Technology must approve all research trials involving humans before they start in the country.

WHO IS IN CHARGE OF THE TRIAL?
The person in charge of the trial is called the Principal Investigator and is usually a doctor. There is a team of doctors and other medical personnel who do the medical exams and blood tests.

HAVE THESE TYPES OF STUDIES (VACCINE TRIALS) EVER BEEN DONE IN UGANDA BEFORE?
YES! Similar studies have been carried out in Uganda by the International AIDS Vaccine Initiative (IAVI), the Joint Clinical Research center (JCRC) and the Makerere University-Walter Reed Project.  These studies were Phase I and II trials using different vaccines.

WHY SHOULD YOU TAKE PART IN AN HIV VACCINE TRIAL?
To help find a vaccine that will prevent HIV/AIDS in Uganda

WILL THE VACCINE PROTECT YOU AGAINST HIV?
These vaccines are experimental and very early in testing. We do not know if they will protect you against HIV. So, you will need to take steps to protect yourself against HIV. You can Abstain from sex, Use condoms or remain mutually faithful in your sexual relationship or marriage. You will be counseled to avoid behavior that could result in contracting HIV/AIDS.

ARE THERE ANY SIDE-EFFECTS FROM GETTING THE VACCINE?
You might have a sore arm for a day or two. As with any vaccine, you might have some symptoms for a few days, such as fever, chills, headache, fatigue, and itchiness. An allergic reaction is possible, so we watch you in the clinic for 30 - 45 minutes after each vaccination. The vaccines are very new, and so we do not know all of the side effects that could happen.

DOES EVERYONE GET AN HIV VACCINE IN THE VACCINE STUDY?
Some people don’t. You might get an injection called a placebo. A placebo may be a kind of salt water solution (saline) or it may have other ingredients, but it will not have any vaccine material in it. You can’t choose to get a placebo and you can’t find out until the study is over whether you got one.

WHAT IS IT LIKE TO BE IN THE STUDY?
Each study/trial is different, so you must learn what is required before you join.  Everything will be carefully explained to you.  If you do not understand, you must ask questions.

WHO CAN TAKE PART IN THE VACCINE STUDY?
Each study has specific requirements. Each person is carefully screened to determine eligibility. You will need to visit our research facility for details on a particular study to determine whether you can or can not join.

WHO SHOULD NOT TAKE PART IN THE VACCINE STUDY?
Each person is carefully screened to determine this. However, general exclusion includes;

• Breast feeding mothers
• Pregnant women
• Individuals who wont be able to regularly attend scheduled clinic appointments during the study period and
• Individuals who are not willing to have an HIV test and receive the results

ARE YOUR RIGHTS PROTECTED IF U DECIDE TO JOIN THE STUDY?
Yes! Your rights are protected / safeguarded by:

• Educating the public to create a well informed and well mobilized community base
• Recruiting trial participants and communities fairly
• Ensuring informed consent
• Taking steps to maximize confidentiality
• Taking active steps to minimize potential harm through frequent monitoring
• Giving you the right to withdraw out of the study at any time
• Employing highly competent research staff
• An independent system of ethical review based on ethical principles and guidelines

WHAT IS INFORMED CONSENT?
Informed consent explains the rules and requirements of the vaccine trial.  It explains the risks and benefits of taking part in the vaccine trial.  You will be asked to sign a form stating that you understand and agree with everything about the trial although you can still leave at any time.

HOW LONG WILL THE TRIAL TAKE?
Most vaccine trials take a year or more.

ARE THERE ANY RISKS TO TAKING PART IN AN HIV VACCINE TRIAL?
There is No risk of becoming infected with HIV. You may be discriminated against if people think you are at risk for HIV or you have a “false positive” HIV blood test. You may suffer some discomfort from having blood drawn or at the injection site.

CAN YOU GET HIV FROM THE VACCINE?
NO! The vaccine does not contain HIV, (the virus that causes AIDS) or HIV infected cells

WILL JOINING THE TRIAL COST YOU ANYTHING?
NO, you will not be charged for any of the tests that the trial requires (such as blood tests).

WILL YOU BE PAID FOR TAKING PART IN THE TRIAL?
NO, although you may receive payment for your time and travel.

CAN YOU STOP TAKING PART IN THE VACCINE TRIAL?
YES! You can stop at anytime.

HOW WILL THE RESEARCHERS KNOW WHETHER THESE VACCINES WORK?
At this early stage of testing (called Phase I and Phase II), we are not testing to see if the vaccines protect anyone against HIV. We are testing the vaccines to see how the body responds. After you are vaccinated, we send your blood to the lab to see if your body has generated a response which can fight HIV.

The only way to see if the vaccines actually protect against HIV/AIDS, is in a large Phase III trial with thousands of volunteers worldwide who are at risk for HIV infection. Some volunteers would receive the vaccine and some would receive placebo (an injection with no actual vaccine material). The number of HIV infections that occurred in the vaccine group would be compared to the number of infections in the placebo group. We’re not there yet, but we’re doing a lot of smaller Phase I trials to find the vaccines that have the best chance of working.