Are there possible benefits from DNA immunotherapies?
It is possible that participants may receive a medical benefit with respect to their disease. The information we receive from these clinical studies may help other patients in the future. However, there is no guarantee that participating in an investigational DNA immunotherapy study will cause any symptoms or underlying disease to improve or go away. There is a chance that by participating you will see no direct benefit.
What are the possible risks?
As with any experimental medicine, it is not possible to predict all of the potential risks. Side effects of vaccination with DNA immunotherapies may include discomfort related to treatment with the electroporation delivery device, such as swelling and pain. In previous human studies of DNA immunotherapies delivered with electroporation there were no vaccine-related serious adverse events. Reported adverse events and injection site reactions were mild to moderate and required no treatment.
Study-related blood tests may cause: bleeding, bruising, discomfort, or pain at the puncture site; infection at the puncture site (rare) and light-headedness.
Note that your health will be monitored very closely during these studies.
Before you decide to participate in a clinical study, talk to your doctor about its potential risks and benefits.
Will I receive payment or have to pay out-of-pocket costs?
Participation in a clinical study is voluntary. There is typically no charge for the immunotherapies, study-related tests, procedures or office visits, or other study medications.
There is typically no payment per se. You may receive compensation for time and travel.
What else should I know about clinical studies?
Click here to learn more about clinical studies in general.
How will my privacy be protected?
All information gathered remains confidential and will be coded with a number to keep your name a secret. No personal information such as your name or contact information will be listed in any reports. The coded information will only be seen by the study team at a clinic; the company paying for this clinical research study, their licensing partner, and business partners and the government agency and ethics committees in the U.S. and other countries.
What will I be asked to do if I participate in the study?
The treatment consists of injection with this investigational study immunotherapy followed by treatment with the electroporation delivery device, which uses brief electrical pulses to try to improve the body’s immune response to the immunotherapy.
What does “randomized” or “double-blind” mean?
“Randomized” means that you’ll be randomly assigned to one of two treatment groups. One group will receive the investigational immunotherapy. The second group will receive a placebo (a “look-alike” with no active drug).
“Double-blinded” means that neither you nor the study doctor will know if you’re receiving the study drug or the placebo until the study is over.
Before being accepted in a study you will have to provide consent. What does it mean to consent?
Consent means that you voluntarily agree to be in the study. Consent involves you reading (or a legally authorized person reading for you) and signing an informed consent document. It also involves a conversation between you and your study doctor that:
- Outlines the details of participation and possible benefits and risks
- Gives you an opportunity to ask questions about clinical research in general and this study
- Based on that conversation, you may decide whether or not to participate in the study
- Throughout your participation, you can withdraw from the study at any time
Questions to ask your physician
Here is a list of questions you may ask your physician about participating in a clinical study.