1. Can I get HIV/AIDS from the investigational vaccine?
No. You cannot get an HIV infection from the vaccine. In this investigational vaccine, scientists created synthetic (man-made) genes. These synthetic genes are designed to make proteins that resemble those present in a real virus. They do not contain the information required to cause HIV infection. Proteins in the vaccine are present for a short time before being broken down by the body. These proteins are look-alikes, are not live, so they cannot cause HIV. There is no virus or infected material in the investigational vaccine, so there is no way that it can cause HIV/AIDS.
2. How does this investigational HIV vaccine work?
The vaccine is designed to work by mimicking the shapes and structures of HIV proteins. They cause the immune system to produce antibodies and lymphocyte responses that may recognize and attack HIV. In this way the immune system may be educated to recognize and potentially respond quickly if you were to encounter HIV. The hope is that the body's natural immunity prepared by vaccination will be able to fight off a real HIV exposure. Please remember that this is an investigational vaccine. We don't know if it works and extensive testing will be needed to eventually answer this question. [Adenovirus specific language: This vaccine is part of a generation of vaccines called "vaccine vectors." A vector is a packaging system that can help deliver the vaccine more effectively into the right part of the body or into the right cell, in order to produce the best possible immune responses. In this study, an adenovirus vector carries synthetic genes into human cells. The adenovirus shell protects the vaccine genes until they are in a cell that can produce the vaccine protein. The adenovirus can not reproduce, cause infection, or damage the immune system, and the HIV genes can not produce infection or reassemble to make a virus.
3. How can I find out if I'm eligible for the study?
Give us a call on +255 25 2503364.
We are looking for healthy HIV negative volunteers between the ages of 18-50.
When you contact our staff, you will have a brief phone conversation. If you meet certain criteria, a screening visit will be arranged. At this visit a complete physical examination and blood work will be done to determine if you are eligible.
4. How long is the study, and how much time will I have to commit?
This depends from study to study for more information about a particular study please get in touch with our clinic.
However if you would like to participate you will have to make sure that you are available for the period of the study.
5. Where and when can I go for appointments?
Study visits are conducted at MMRC Clinic, at the Mbeya Referral Hospital. Regular clinic hours are Monday through Friday from 8:00 AM to 4:30 PM.
We can usually schedule clinic visits at other times to meet individual needs; however we cannot conduct visits on holidays or weekends.
6. What if I move out of town?
If you move out of the area within the first few months of starting a study, we may not be able to monitor you adequately.
When you contact a MMRC staff member, please discuss with us any relocation or extended travel plans.
7. Will I be paid for my participation?
Volunteer payments are based on "inconvenience" costs and intended to partially compensate volunteers for their travel expense and time lost from work.
These payments are not likely to fully cover the real cost for average Tanzanian volunteer. The payments are made after each visit and are not given as a lump sum.
8. What if I test "false-positive" for HIV?
To be eligible for a study you must be HIV negative. Some investigational vaccines may be strong enough to cause an antibody response detectable on standard HIV tests. These tests measure the body's antibody response to HIV, and do not directly measure HIV itself. Therefore, having a false-positive antibody test for HIV after vaccination is not unexpected. It does not mean you are infected. At every visit, we perform specialized testing to prove that you are not HIV infected. No medical side effects or problems are associated with having a false-positive antibody test. Remember, this vaccine contains no live virus, so you cannot be infected with HIV or develop AIDS from this vaccine.
9. Can I donate blood during or after the study?
You cannot donate blood, blood products such as platelets, or bone marrow during the study. In addition, blood banks will not accept donations for one year after the last dose of an investigational vaccine. Also, please do not donate blood six weeks before starting a study because we cannot draw blood required for screening.
10. What side effects can I expect from the investigational vaccine?
You might have short-term side effects similar to those from any vaccination such as arm soreness. Since this vaccine has not been given to people, there may be risks or side effects that are not known.
Prior to the study, a medical personnel will describe all possible side effects with you, even those that are theoretical.
11. Will this vaccine protect me from HIV?
There is no evidence that this investigational vaccine will protect you from getting HIV infection. The main purpose of this study is to test whether the investigational vaccine is safe and tolerable. You should avoid high-risk behavior that would put you at risk for HIV infection.
12. Will the vaccine cause me to transmit HIV?
No. This vaccine is not made from live virus or HIV infected cells.
There is no possibility that it contains live or killed HIV; therefore, it is impossible to be infected with HIV or develop AIDS from the vaccine.
13. How will you know if this vaccine works?
Certain times after receiving each injection, specialized laboratory testing will be done on your blood to see if your immune system responds to the vaccine. The results of these tests will be evaluated and compared to what we have learned about vaccine-induced protective responses in animal studies. We will not expose you to the virus at any time and ask that you avoid any risk that may cause you to be exposed to the virus. Specific counseling will be available to help you stay HIV uninfected during the trial. This vaccine is part of a global effort to create a safe, effective vaccine for HIV. After trials are completed at this site, our vaccine will be placed into expanded clinical trials in the United States and around the world. Eventually large trials will be done to see if the vaccine can reduce the rate of HIV infection.
