Genital Herpes Vaccine Partially Successful

Results of a clinical trial show that an investigational vaccine for genital herpes protected some women against infection from one of the two strains of virus that cause the disease. Although the results show only partial success, the researchers who conducted the trial believe they represent progress towards a genital herpes vaccine. They write about their findings in the 5 January online issue of the New England Journal of Medicine.

There is currently no cure or approved vaccine for genital herpes, a sexually transmitted disease caused by the viruses herpes simplex type 1 (HSV-1) and herpes simplex type 2 (HSV-2), with most infections thought to be caused by the latter (although a surprising finding of this study suggests that could be changing).

Genital herpes is one of the most common communicable diseases and affects about 1 in 4 women in the United States.

HSV-2 generally causes lesions and blisters in the genital area, and while HSV-1 generally causes sores in the mouth and lips, it has increasingly been found to cause genital disease.

Once inside the body, the virus stays for good. It can cause severe neurological disease, and even death in babies born to women infected with the virus, which is also a risk factor for sexual transmission of HIV.

In the NEJM study, the researchers report that an investigational vaccine developed by GlaxoSmithKline (GSK) provided partial protection agaist HSV-1 in a clinical trial involving more than 8,000 women at 50 sites in the US and Canada. The trial was funded by GSK and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health.

There were 58% fewer cases of HSV-1 in women who received the vaccine compared to women who received the control. It did not protect women against HSV-2.

In a note to the press, lead author Robert Belshe, director of the Center for Vaccine Development at Saint Louis University in Missouri, said:

"There is some very good news in our findings. We were partially successful against half of the equation -- protecting women from genital disease caused by HSV-1."

"It's a big step along the path to creating an effective vaccine that protects against genital disease caused by herpes infection. It points us in the direction to work toward making a vaccine that works on both herpes simplex viruses," he added.

Belshe and some of the other authors report having commercial relationships with GSK and other drug companies, such as receiving consultancy and lecture fees.

For the trial, they enrolled 8,323 women who were free of HSV-1 or HSV-2 infection. Their ages ranged from 18 to 32 at the start of the trial, and they were randomly assigned to receive either three doses of the vaccine or a control vaccine (one that prevents hepatitis A).

The researchers followed the participants for 20 months, monitoring for occurrence of gential herpes infection. During the trial, all participants also gave blood samples from which tests showed whether they were carrying HSV-1 or HSV-2 without showing symptoms.

The results showed that two of the three doses of the investigational vaccine offered protection against genital herpes from HSV-1. None offered protection against genital disease caused by HSV-2.

The authors summarize the results in their abstract:

"Overall, the vaccine was not efficacious; vaccine efficacy was 20% (95% confidence interval [CI], -29 to 50) against genital herpes disease. However, efficacy against HSV-1 genital disease was 58% (95% CI, 12 to 80). Vaccine efficacy against HSV-1 infection (with or without disease) was 35% (95% CI, 13 to 52), but efficacy against HSV-2 infection was not observed (-8%; 95% CI, -59 to 26)."

Belshe, who also is a professor of infectious diseases and immunology at St Louis, said they were surprised by the findings:

"We didn't expect the herpes vaccine to protect against one type of herpes simplex virus and not another. We also found it surprising that HSV-1 was a more common cause of genital disease than was HSV-2."

It has been suggested that HSV-1, once thought to cause mainly oral disease, is increasingly becoming a cause of genital disease because couples are engaging in oral sex.

Belshe explained that both HSV-1 and HSV-2 spread through direct contact, for instance from mouth to mouth, genitals to genitals, and mouth to genitals, even when infected persons have no symptoms.

The researchers are continuing to investigate why the vaccine only protected women against HSV-1 and not HSV-2. They are conducting tests on serum donated by the study participants.

Belshe suggests one reason could be that HSV-1 is more vulnerable to antibodies than HSV-2.

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What Is Herpes? What Is Genital Herpes?

Genital herpes is a sexually transmitted infection caused by HSV (herpes simplex virus). This virus affects the genitals, the cervix, as well as the skin in other parts of the body. There are two types of herpes simplex viruses: a) HSVp1, or Herpes Type 1, and b) HSV-2, or Herpes Type 2.

Herpes is a chronic condition. Chronic, in medicine, means long-term. However, many people never have symptoms even though they are carrying the virus. Many people with HSV have recurring genital herpes. When a person is initially infected the recurrences, if they do occur, tend to happen more frequently. Over time the remission periods get longer and longer. Each occurrence tends to become less severe with time.

HSV is highly contagious

The herpes simples virus (HSV) is easily human transmissible. It is passed from one person to another by close, direct contact. The most common mode of transmission is through vaginal, anal or oral sex. When somebody becomes infected with HSV, it will generally remain dormant.

Most people who are infected with HSV do not know it because their symptoms are so slight - many people have no discernible symptoms.

What are the symptoms for genital herpes?

For those who do experience symptoms, they are generally present as blisters on the genitals, and sores around the mouth.

Most people do not have apparent symptoms for many months, or even years after becoming infected. Those who do have symptoms during the initial period will usually notice them about 4 to 7 days after being infected.

Primary infection symptoms

Primary infection is a term used for an outbreak of genital herpes that is evident when a person is first infected. Primary infection symptoms, if they are experienced, are usually more severe than subsequent recurrences. Symptoms can last up to 20 days and may include:

• Blisters and ulceration on the cervix
• Vaginal discharge
• Pain when urinating
• A temperature (fever)
• Malaise (feeling unwell)
• Cold sores around the mouth
• Red blisters - these are generally painful and they soon burst and leave ulcers on the external genital area, thighs, buttocks and rectum

In most cases the ulcers will heal and the patient will not have any lasting scars.

Recurrent infection symptoms

These symptoms tend to be less severe and do not last as long, because the patient's body has built up some immunity to the virus. In most cases symptoms will not last for more than 10 days.

• Burning/tingling around genitals before blisters appear
• Women may have blisters and ulceration on the cervix
• Cold sores around the mouth
• Red blisters - these are generally painful and the soon burst and leave ulcers on the external genital area, thighs, buttocks and rectum

Eventually recurrences happen less often and are much less severe. Patients with HSV-1 will have fewer recurrences and less severe symptoms than people infected with HSV-2.

What causes genital herpes?

When HSV is present on the surface of the skin of an infected person it can easily pass on to another person through the moist skin which lines the mouth, anus and genitals. The virus may also pass onto another person through other areas of human skin, as well as the eyes.

A human cannot become infected by touching an object, such as a working surface, washbasin, or a towel which has been touched by an infected person.

The following can be ways of becoming infected:

• Having unprotected vaginal or anal sex
• Having oral sex with a person who gets cold sores
• Sharing sex toys
• Having genital contact with an infected person

HSV leaves the skin just before a blister appears. The virus is most likely to be passed on just before the blister appears, when it is visible, and until the blister is completely healed. HSV can still pass onto another person when there are no signs of an outbreak (but it is less likely).

If a mother with genital herpes has sores while giving birth it is possible that the infection is passed on to the baby (see section on pregnancy below).

How is genital herpes diagnosed?

Anybody who has genital herpes symptoms should see his/her GP (general practitioner) or go to a sexual health clinic or a genito-urinary medicine (GUM) clinic. Anything discussed or discovered is completely confidential. An initial diagnosis of genital herpes should ideally be made by a GUM specialist - however, if you cannot see one go to your GP. A GP may refer the patient to a specialist. Before doing so, he/she will ask the patient some questions regarding possible signs and symptoms and carry out an examination.

Herpes is much easier to diagnose when the infection is still present.

A health care professional will take a swab sample of fluid from the infected area - this may require gently breaking the blister. The sample will be sent to a laboratory. If the result comes back negative it does not necessarily mean the person does not have genital herpes. Confirmation is more likely if the patient has subsequent recurrences.

Blood tests can also be used to find out if a person is infected. However, blood tests may miss very recent infections.

Diagnosing recurrent infections of genital herpes

Anybody who has a recurrent bout of genital herpes should see his/her doctor. The doctor will ask about the symptoms, and previous bouts. He/she will also try to find out whether this outbreak, or previous ones, might have been triggered by something, such as illness, or stress. The doctor will examine the genital area in order to determine the severity of the infection.

What are the treatments for genital herpes?

Self-help

• Pain - paracetamol (Tylenol, acetaminophen) or ibuprofen can be bought without a prescription.


• Some people find that bathing in lightly salted water helps relieve symptoms.


• Ice packs can help. Make sure the ice is wrapped in something - do not apply ice directly to the skin.


• Apply Vaseline (or some kind of petroleum jelly) to the affected area.


• If urinating is painful apply some cream or lotion to the urethra, for example, lidocaine. Some people find that if they urinate while sitting in warm water it is less painful.


• Do not wear tight clothing around the affected area.


• Wash your hands thoroughly, especially if you have touched an affected area.


• Refrain from sexual activity until symptoms have gone.

Medication

There is no drug that can get rid of the virus. The doctor may prescribe an antiviral, such as acyclovir. Acyclovir is usually taken five times a day. It prevents the virus from multiplying. A course of acyclovir lasts five days if the patient still has new blisters and ulcers forming in the genital area when treatment started. Antiviral tablets will help the outbreak clear up faster - they will also help reduce the severity of symptoms. Antivirals are generally given the first time a patient has symptoms.

As recurrent outbreaks are milder, treatment is not usually necessary.

Episodic treatment and suppressive treatment

• Episodic treatment - this is generally for patients who have less than six recurrences in one year. A five-day course of antivirals is prescribed each time symptoms appear.


• Suppressive treatment - if a patient has more than six recurrences in a year, or if symptoms are very severe, antiviral treatment may last longer. The aim here is to prevent further recurrences. Some patients may have to take acyclovir twice daily for several months. Although suppressive treatment significantly reduces the risk of passing HSV to a partner, there is still a risk.

Genital herpes during pregnancy

If a mother became infected before she got pregnant the risk of infecting her baby is very low. This is because her antibodies will be passed on to the baby. The longer the mother had the infection before becoming pregnant, the better her immunity will be, and that will be passed on to the baby. Those antibodies protect the baby during the birth and for many months afterwards.

For a woman who became infected during the first 13 weeks (first trimester) of her pregnancy, the risk of infecting the baby is slightly higher. If infection happens later on during the pregnancy, the risk continues to increase. Most women who became infected during their pregnancy are advised to take aciclovir (antiviral medication) during their pregnancy.

The risk of passing the infection on to the baby is considerably higher if the mother became infected during the late stage of pregnancy. The risk of infection for the baby is during, or just before the birth. Doctors will often advise the mother to have a cesarean section delivery. The mother will also be taking antiviral medication. A mother who has recurrent infections of genital herpes during the third trimester of her pregnancy may need to have a cesarean section if she has blisters and ulcers in her genital area around the date of the birth. Most doctors will not advise a cesarean section delivery if there are no sores and the mother has been infected since before she got pregnant, as the risk of passing the infection on to the baby is very small.

Prevention

To reduce the risk of developing or passing on genital herpes:

• Use condoms when having sex
• Do not have sex while symptoms are present (genital, anal, or skin-to-skin)
• Do not kiss when there is a cold sore around the mouth
• Do not have many sexual partners

Some people find that stress, being tired, illness, friction against the skin, or sunbathing may trigger recurrences of symptoms. Avoiding such triggers, if they can be identified, may help reduce the number of recurrences.

Some herpes facts

"People who have genital herpes can have sex. They should avoid sexual contact if they have symptoms. Wearing condoms helps prevent passing it on."

"More than 50% of the population of the USA has herpes. Most of them don't know it."

"Receiving oral sex from somebody who has cold sores around their mouth significantly raises the risk of becoming infected."

"You cannot get genital herpes from a toilet seat."

"Genital herpes can spread from one part of your body to another."

"If you never have symptoms, this does not mean you do not have genital herpes."

"Stress can trigger a recurrence of symptoms."

"People who have genital herpes are more susceptible to HIV."

"Genital herpes cannot make you sterile."

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