Who were the volunteers in these studies?
The volunteers who participated in the past studies were individuals living in UK, Kenya, Uganda and Switzerland. Anybody could participate in these trials regardless of race, ethnicity or gender provided they met the study entry criteria. The volunteers were healthy men and women at low risk of acquiring HIV who are interested in helping ensure that a preventive HIV vaccine is developed as soon as possible.
Were these HIV vaccine studies approved?
Permission to conduct the Kenyan HIV vaccine studies was given by the Kenyan Government and ethics committees both in the UK and Kenya.
Was the HIV vaccine being used in this study safe?
The vaccine that was tested had already been used in Phase I testing in humans in the UK, Kenya, Uganda and Switzerland. So far, at least 300 healthy volunteers were vaccinated. Before the vaccine was approved for testing in humans it was extensively studied in animals and no significant side effects were observed. The aim of a Phase I trial is to evaluate safety.
How was this vaccine administered?
The number of injections depend on the design of the particular study. In past studies, the number of injections has been between 2 and 8. The injections can be given into the skin, just below the skin or into the muscle of the upper arm. The injections are alternated between left and right arms.
How long does this vaccine stay in the body?
The vaccine that KAVI was studying stays in the body for a short time only – on average 1 month. It is the long-term response of the immune system that is important.
What sort of side effects might this HIV vaccine cause?
Some participants may experience pain, tenderness, redness or swelling at the injection site, or mild flu-like symptoms such as headache and fever. Some participants, however, may experience no side effects at all. In past studies, volunteers have been asked to come to the clinic between 2-4 days and 10-14 days after each vaccination for review of any side effects. They were also given a telephone number to call in case there were any problems. Although all of our tests in animals indicate that the vaccine is safe, there always remains a small risk of unexpected side effects or reactions. It is unknown whether receiving this HIV vaccine will alter your immune response to any future HIV vaccine that you might receive.
Can this vaccine cause HIV/AIDS?
No, it cannot. The vaccine was artificially made and there is no risk of acquiring HIV from the vaccine. The vaccine does not contain killed or weakened HIV and does not contain any material from HIV-infected individuals or from individuals found to be resistant to HIV. Nor does it contain any blood or blood components.
Will one test HIV-positive after receiving this HIV vaccine?
It is possible that individuals who receive this vaccine will test HIV positive (false positive) with the standard tests. However, in case someone does, we have available alternative tests that can easily differentiate between a false positive HIV test due to the vaccine and a positive test due to natural HIV infection.
Will this HIV vaccine protect against HIV/AIDS?
We do not know at this point if the vaccine will protect vaccinated individuals from getting HIV/AIDS. Volunteers are advised to continue to practice the recommended prevention methods and keep the risk of HIV infection low.
Why should I participate in an HIV vaccine study?
HIV/AIDS is a global disaster. About 14,000 new infections occur every day, 95% of which occur in developing countries. Countries in Sub-Saharan Africa have been hit hard by the epidemic. It is estimated that currently 40 million people worldwide live with HIV/AIDS. In Kenya, about 2 million people are living with HIV/AIDS and 700 individuals are getting infected daily. Preventive methods such as education, risk reduction counselling and condom promotion have been put in place and have shown some effect to control the spread of HIV/AIDS. Drugs that are available to treat people with HIV/AIDS cannot cure anybody from AIDS and do not stop the spread of HIV. The only real hope to stop the spread of HIV is by a safe and effective preventive vaccine. The development of such a vaccine requires the participation of human volunteers. Without you and other volunteers we will not be able to develop a safe and effective vaccine to prevent the spread of AIDS.
Who can join a HIV vaccine study?
To Join a KAVI study you must meet all the study inclusions criteria as follows - Age between 18-60years - In good health - HIV negative - At lower risk of acquiring HIV-infection - Not pregnant or your partner is not planning to become pregnant in the next year - In a position to visit the study center over a period of 18 months.
How do I become a volunteer?
Studies are taking place at the Kenya AIDS Vaccine Initiative (KAVI) Centre located at the Department of Medical Microbiology at the University of Nairobi at Kenyatta National Hospital. Talk to the study team there about what is expected of you. Do not be afraid to ask questions. It is important that you feel comfortable participating in a study and that you understand all the details about the study.
How do volunteers agree or consent to participate?
A volunteer who decides to participate in a clinical trial must confirm in writing that he/she agrees to participate and that it is his/her free will to participate. It implies that the volunteer understands what participating in a study involves and what the potential risks and benefits are. The study team will ensure that the participants are properly and adequately informed about the purpose of the study and all procedures involved. All questions participants may have must be appropriately addressed. Only after the volunteer has understood the details of the study can he/she give informed consent. Consent is given in writing by signing a form. This happens before entering a study and before any procedures are carried out. However, signing the consent form does not mean that a volunteer is bound to stay in the study. A volunteer may decide to leave the study any time without having to explain the reasons.
What happens before entering a study?
Individuals who express interest in participating in a study will be invited to come to the Kenya AIDS Vaccine Initiative (KAVI) Centre, Department of Medical Microbiology, University of Nairobi at Kenyatta National Hospital HIV/AIDS Division for a series of information seminars. The study team will provide information on the study and answer any questions you may have. You will then be given a questionnaire to complete at your convenience. For those who successfully complete the questionnaire and are interested in participating, an appointment will be made for a screening visit.
What happens at the screening visit?
Before signing the informed consent, a counsellor will provide you with more information about the screening, including HIV testing. After signing the consent form, a complete medical history will be taken and a physical examination performed. A sample of your blood will be taken for routine tests including a test for HIV infection. After that you will be given an appointment to come back for a review of the results and enrollment, if you fulfill enrollment criteria.
What happens to the blood that you take from me?
We will use the blood in the laboratory to find out whether the vaccine causes any changes in the way your organs (such as kidneys or liver) work and what effects the vaccine has on your immune system. We will see from laboratory tests whether the vaccine can stimulate the right kind of immune responses to fight against HIV.
What happens if I test HIV positive at screening?
Should you be found to be HIV-positive at screening, you will not be enrolled in the study. You will be given information on where to find appropriate counselling and standard medical care.
How long does a study last for?
A Phase 1 clinical study lasts for about 18 months, Phase II study lasts 2 year while a Phase III study lasts 3 – 4 years.
How many visits will I have to make to the clinic during a study?
Once you are enrolled in a study you will be asked to come to the clinic approximately 18 times in total. This includes 2 visits following each vaccination. Some visits, including the enrollment visit, will involve blood draws.
How many times will I receive the vaccine?
The number of vaccinations depends on the study in which you are enrolled. For instance, in the fourth study KAVI conducted, volunteers received 4 vaccinations over an interval of 8 months. Some studies are designed for volunteers to receive a total of 8 injections.
Will everybody in the trial receive the candidate vaccine?
No, in the design of these studies some individuals will receive a placebo (a “dummy” vaccine), which is a substance that looks like the vaccine, but does not contain the vaccine.
Who will decide whether I get the vaccine or the placebo?
Your assignment to either one of the vaccine groups or the placebo group will be made automatically by a computer. This process is called randomization. It is like the tossing of a coin.
Will I know whether I received the vaccine or the placebo?
No, neither you nor the researchers will know who has been given the placebo or the vaccine until the end of the study. This is called blinding. Only the people who generate the code list, people who package and label the vaccine as well as the person preparing the vaccine immediately prior to administration will know the code. None of these people will be involved in any clinic or laboratory evaluations during the study. The code may be broken in case of a serious adverse effect.
Why is blinding necessary?
Blinding is necessary so that people evaluating you are not influenced by what they know (whether you got vaccine or placebo). This ensures accurate assessment of the safety of the vaccine.
If I receive the vaccine, does this pose a health risk to my partner or family?
No, it is unlikely that the vaccine could be transmitted to others by close or intimate contact and therefore should not pose a health risk to your partner or family. To avoid leakage from the vaccine the vaccination site will be covered with a bandage for 60 minutes after the injection.
Will there be payment to participate in a study?
No, there is no payment for your participation in a study. You will, however, receive reimbursement for your travel expenses to the clinic for scheduled/planned visits.
Will I receive health care if I participate in a study?
Participating in a vaccine study is not the same as receiving health care. However, if you experience vaccine-related injuries you will receive appropriate treatment free of charge and/or be referred as needed. We would like to emphasize that if during the study period you don’t feel well you should come to the study center, where the clinicians will be happy to answer any questions you might have.
Who will be informed about my participation?
The study team will NOT inform anybody about your participation in a study. The entire team is bound to keep all information collected from study participants absolutely confidential. This means that your identity will never be disclosed. However, it is entirely up to you whether or not YOU want to inform anybody about your participation in a study.
Do I have to tell anybody that I participate in a study?
No, you don’t have to tell anybody about your participation. If you do, it is your choice to do so. The study team will keep your participation, and any personal or medical information collected from you, confidential.
What happens if I become HIV infected during a study?
You cannot get HIV infection from the vaccine. During a study we will repeatedly test for HIV. Should you get HIV infected, you will be followed-up until the end of the study. You will receive information on where to find appropriate counseling and medical care.
What happens at the end of a study?
The last follow-up visit is scheduled approximately 18 months after enrollment. At the end of the study you will be informed about the results of the study.