A Patient’s Guide to Clinical Trials
En Español | En Français
NIH Clinical Research Trials and You
Guidance regarding HIV anti-retroviral treatment in developing countries
Policy on Research Involving Human Subjects
If you have never been infected with herpes, then you will not get the infection from this vaccine. Scientists created the vaccine by removing two important genes that are required for the virus to grow. Therefore, the vaccine cannot grow and multiply. Since infectious virus is not present in the investigational vaccine, it is not possible for you to get herpes from this vaccine.
If previously you have been infected with herpes, it is extremely unlikely that you may get re-infected with the vaccine virus if it combines with the natural herpes virus that is already in your body.
The vaccine is a defective virus, meaning it cannot grow because two genes that are required for the virus to grow have been removed. However, the vaccine virus can infect cells and then make nearly all of the herpes virus proteins for a short time. If this happens, the immune system will be able to make antibody and immune cell responses to these proteins. In the future, if a vaccinated person is infected with herpes virus, the immune system might then recognize the virus and respond quickly to prevent or control the infection. Please remember that this vaccine is investigational. We do not know if it will work. This first study in humans is to determine if the vaccine is safe. More studies are needed to see if this vaccine can prevent herpes virus infection or disease.
The main purpose of the herpes vaccine study is to test whether the investigational vaccine is safe and well tolerated. Forty-five people in the study will receive the vaccine and 15 people will receive saline (a salt solution). You and the study investigators will not know which people get the vaccine and which saline during the study. When the study is completed and the results have been analyzed, we will let you know which you received, if you would like to know. Since we are studying this new investigational vaccine for the first time in humans, there is no evidence about whether or not it will work. During a study, blood samples are collected at certain times after each injection is given. We will monitor you for side effects from the vaccine. Laboratory tests will be done on your blood samples to check for the response of your immune system to the injection. We will not expose you to natural herpes virus at any time. This study will help us develop a plan for future investigations.
No, the investigational vaccine will not cause you to spread herpes virus. The herpes virus vaccine cannot grow in normal human cells, and therefore, will not be shed and cause you to spread herpes virus.
Last Updated May 01, 2013
Last Reviewed May 01, 2013