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Clinical Trails

FAQs


Frequently Asked Questions: For Individuals Not Infected with HIV and Who Want to Help in the Fight Against HIV



Can I become infected with HIV from receiving the vaccine?
NO! You cannot become infected with HIV from this vaccine. The vaccine being tested in this study is artificially made. It does not contain any material from live HIV. It does not contain blood or blood products, or material from individuals who are infected with HIV. The vaccine contains artificially made DNA (genetic information) that resembles a small part of the DNA found in HIV.

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Are there any risks involved?
Following the administration of the vaccine or placebo, one may experience pain, soreness and redness, swelling formation of a crust or scab, skin damage and bruising around the site of injection.

Following vaccination, one may test HIV positive on a routine HIV antibody test. This does not mean that you have HIV or AIDS. It could mean that your body has been exposed to the vaccine and has produced antibodies.

In case of a positive HIV antibody result, an independent laboratory will confirm whether you tested positive as a result of the vaccination or whether you got infected with HIV through exposure in the community.

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How long is the study? How many visits are there?
The study will last 16 months from the time an individual enrolls (post screening). There are 16 visits involved plus the screening visit. There are three vaccination time points. The first vaccination will take place on your first official visit, after your screening visit. The second vaccination will take place eight weeks later and the third vaccination will take place 8 weeks after that. The remaining visits are follow-up visits.

Each visit includes a physical exam by a physician and a blood draw.

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How are the payments arranged?
For individuals who participate in the study, there will be a compensation of $100 per visit after the initial screening visit to help pay for your costs or time spent being in this research study.

Participants will be compensated $100 per visit (excluding the screening visit).

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How is the study designed?
If you are eligible for the study and you choose to take part, you will be randomly assigned (which means by chance or like in a lottery) by a computer to be enrolled in one of two study groups, the regular injection group or the electroporation group.

If you are assigned to the electroporation group, you will receive either an injection of the ADVAX vaccine or an injection of a placebo. Neither you, nor the study team, will know if you are receiving the vaccine or the placebo. Once the clinical trial has come to an end, meaning all volunteer visits have been completed, all volunteers will be informed whether they received the placebo or vaccine. YOU SHOULD NOT CONSIDER YOURSELF PROTECTED FROM HIV EVEN IF YOU RECEIVED THE VACCINE.

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What exactly is electroporation? Does it hurt?
Instead of a regular needle and syringe, a small, hand-held device will be used to inject the ADVAX vaccine or placebo into your arm muscle. A member of the study team will press the device against your skin and press a button. Although you will not be able to see them, the device will insert an injection needle and four thin wires into your muscle. The experimental vaccine or placebo will be given through the injection needle into your muscle.

After the injection, the device will give a very short electric signal to your muscle at the spot of the injection. The electrical signal will last for about one half second. You will feel twitching in your muscle which may be painful. Immediately after the electrical signals are finished, the device will be removed from your muscle. Your muscle will be sore to the touch after the electroporation procedure. The electroporation device has not been used to deliver the ADVAX vaccine in any previous human study. The TriGrid™ electroporation system is an experimental device. The United States Food and Drug Administration have allowed this device to be used in this study.

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Will this vaccine protect me from getting infected with HIV?
Since this is an experimental vaccine, we do not know whether the vaccine will protect an individual from becoming infected with HIV. Therefore, participants should still protect themselves from HIV infection during the trial and after trial completion. You should not consider yourself protected from HIV infection when participating in this trial.

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