Australian Herpes Management Forum

Herpes Vaccine Study

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Contributed by Margaret Piper, Clinical Trials Coordinator

Note

The herpes vaccine trial is no longer accepting new applicants.

What is the study about?

This is a study about a virus called herpes simplex virus (HSV). We would like to test a new vaccine for one of the main types of HSV – HSV type 2.

Vaccines are given to people before they develop a disease, to stop them from getting the disease in the future. Disease means the symptoms of herpes such as sores and pain in the infected area.

We have provided this information because we are inviting you to take part in our research study. This page will give you information about our study so you can decide whether you want to take part.

What is HSV?

HSV stands for Herpes Simplex Virus. HSV is a virus (germ) and it is spread from person to person by contact with infected skin. There are two types of HSV. HSV type 1 is usually found on the face and causes things like cold sores. HSV type 2 causes painful sores and blisters in the genital areas in men and women. There is no cure for HSV infection. After infection, the virus remains in your body for your entire life. Usually it is inactive or ‘asleep’ but the sores can keep coming back. In addition, babies can get the infection from their mother, and this can lead to serious problems for the baby.

Who can get HSV?

Males and females can get HSV by direct contact (touching) with an infected person. People usually get HSV type 2 by having sex with a person who already has HSV type 2 and HSV type 1 from kissing and other contact with a person who already has HSV type 1.

What is the HSV vaccine study?

Because there is no cure for HSV, doctors and scientists are studying ways of preventing people from getting herpes disease once they are infected with HSV. One way is by the use of a vaccine. A vaccine is a kind of medicine that prevents a disease from happening. You probably have received some vaccines before to protect you from other diseases like measles or hepatitis B. In this study, doctors and scientists will be testing a new HSV vaccine for HSV type 2 disease to make sure it is safe to use in girls aged 10 – 17 years.

There will be about 6000 girls from around the world taking part in this study, 104 girls in Sydney. This vaccine has already been tested in about 7500 people, including 222 teenagers. You cannot get HSV from getting this vaccine. Girls in the study will be randomly put into one of three groups by a computer: half of the girls will get the HSV vaccine, one quarter will get a hepatitis A vaccine and the other quarter will get a saline injection (salty sterile water). These last two groups let us compare reactions to the HSV vaccine with other medications that are known to be safe. You will not get to choose which group you are in, and you will not know which group that is until the end of the study.

Why should I take part in the study?

If you take part in the study you will be helping doctors and scientists to try to come up with a way to prevent HSV disease and infection. This could help many other people in the future.

Who can take part in this study?

To be able to take part in the study, you:

• must be a healthy girl between 10 and 17 years old
• must not be planning to have sex with anyone for the first eight months of the study or must agree to use good contraception methods if you do have sex
• must not be planning to move away for 18 months (during the study)
• must not be pregnant or breastfeeding
• must not have had herpes (genital or oral) before

What will happen if I agree to take part in the study?

If you take part in the study, you:

• will be visited at school by a doctor and the Clinical Trials co-ordinator or you may attend Westmead Hospital five times over 12 months
• will be telephoned at home to check on how you are feeling every month for 12 months, with an extra call at 18 months
• will have your temperature, pulse, height, weight, and blood pressure recorded on the first day
• will be asked about how you are feeling and what medications you have been taking at every visit
• will be asked at every visit about whether you have started having your periods
• will have a blood test at three different times (a numbing patch can be used so the blood test doesn’t hurt)
• will receive a vaccine or saline through an injection in the arm at three different times
• will have a urine pregnancy test before you receive each dose of the vaccine

Are there any side effects from the vaccine?

The following side effects have been reported by some people who received the HSV and hepatitis A vaccines:

• Pain, redness or swelling where the vaccine was given
•  Feeling tired
•  Headache
• Mild fever
• Feeling unwell
• Feeling sick in the stomach

 In all of the studies that have been done to date, only nine people have reported more serious side effects after getting the HSV vaccine. These effects include:

• Flu like symptoms
• Rash
• Tingling of the face, head and throat
• Vomiting
• Fainting
• Seizures (convulsions or ‘fits’)
• Inflammation of the eyes or brain
• Dizziness, fatigue (very tired) and weakness.

The study doctor and the Clinical Trials co-ordinator can discuss these possible side effects with you.

For more information

Please note that recruitment for the trial is now closed; no further applicants are required.

• Call (02) 9845 6251 and ask for the Clinical Trials co-ordinator.
• Send email to Margaret Piper, Clinical Trials Coordinator

8 March 2005

More Information

Clinical Trials Coordinator:
02 9845 6251
Send email

More genital herpes information

Note: The AHMF is not conducting this trial. Please direct all questions to the Clinical Trials Coordinator.