World's Largest Hiv Vaccine Trial Delayed

[george]

World's largest HIV vaccine trial delayed

Successful trials will give life-long protection against the HIV virus

BANGKOK: -- The results of the world's biggest HIV vaccine trial, which began in Thailand early this year, will be delayed by a year because it has failed to recruit enough participants, officials said on Wednesday.

Project director Dr Supachai Rerks-Ngarm said the organisers aimed to rope in 16,000 people but that so far about 5000 of 7000 volunteers had passed the screening process.

"We thought the recruitment process would only take one year, but we need more time so we will have to extend for another year," he told AFP.

Supachai said participants had to meet criteria including that they be aged between 20 and 30, in good health and HIV-negative.

Many prospective candidates were rejected because they did not meet the standards.

"We have established a strict screening process to maintain maximum standards in carrying out the trial," he told AFP, adding that about 3000 people have already received the vaccine.

The recruitment process was initially scheduled to run for one year from September 2003, with the results of the study due five years after the start of the project in early 2004.

The trial is the first to determine the efficacy of an HIV vaccine, in a so-called "third phase" test carried out after the first and second phases ensured it was safe for humans.

A phase three trial involves large-scale testing on ordinary citizens in a real-world situation, and is the last hurdle before the vaccine can be registered and administered freely.

Life-long protection

"We thought the recruitment process would only take one year, but we need more time so we will have to extend for another year"

Dr Supachai Rerks-Ngarm,

Project director

The project is being held in the two eastern provinces of Chonburi and Rayong, where 47 screening centres and eight vaccine injection centres have been established.

A combination of two vaccines developed by Aventis Pasteur and VaxGen will be administered over six months in six injections, and volunteers' progress will be monitored every six months for three years.

If successful, the therapy would give life-long protection against the HIV virus that causes AIDS.

The trial is a collaborative effort among the United States Military HIV Research Program, the Royal Thai Army Medical Department and the US National Institute of Allergy and Infectious Diseases.

Thailand is to host the World Aids Conference from 11 to 16 July, in recognition of the growing crisis faced by the Asia Pacific region where infection rates are rising rapidly in many nations.

--Agencies 2004-06-24

[Up2U]

Is the intention that people who have this vaccine shall then go out, screw around having unprotected sex and then show that they do not have AIDS? (But still collect a whole bucket-full of other STD's)

Sounds completely irresponsible and typical Thai-US cooperation.

[daveh]

Is the intention that people who have this vaccine shall then go out, screw around having unprotected sex and then show that they do not have AIDS? (But still collect a whole bucket-full of other STD's)

Sounds completely irresponsible and typical Thai-US cooperation.

No, that is not how it typically works. They normally inject half the subjects with a placebo, and the other half with the test drug. They ask that they do not change their behavior. And since you don't know if you got the drug or a placebo, you are likely to keep doing what you have been. That is, if you normally have unprotected sex, then you will continue having it. If you normally use a condom, then you will continue doing so. Then after the trial, they compare the test subjects with the control subjects.

Remember, even while using condoms, there is a chance of condom failure. So for 8000 people who are acting responsibly, there will be many occurances of a chance to contract AIDs simply through condom failure.

If they wanted to act irresponsibly, they would take 100 prisoners who are currently HIV negative, give them the vaccine, then inject them with HIV. That would be irresponsible. And doing no trial at all would be more irresponsible. But doing a trial in Thailand is far from irresponsible.

I wonder the same thing as you regarding other STDs. If this is a good vaccine, I wonder what will happen to the infection rates of the other STDs after everyone has been vacinated. I am sure there are plenty of people in the world who only use a condom to protect themselves against AIDs. I suspect that herpes, and HPV will be on the rise.

One other thing I wonder about. Many vaccines use a dead form of the virus. They inject this into your system, then your system creates antibodies for it so when the live virus comes along, it can fight it off. But in Thailand, it seems the "AIDs test" you get in a clinic or hospital is actually an HIV antibody test. The more expensive tests test for the DNA of the virus itself. So I am wondering what the test results would be viewed if this vaccine is in fact a dead virus. Meaning, will you test positive if you have this vaccine?

[cathyy]

One other thing I wonder about. Many vaccines use a dead form of the virus. They inject this into your system, then your system creates antibodies for it so when the live virus comes along, it can fight it off. But in Thailand, it seems the "AIDs test" you get in a clinic or hospital is actually an HIV antibody test. The more expensive tests test for the DNA of the virus itself. So I am wondering what the test results would be viewed if this vaccine is in fact a dead virus. Meaning, will you test positive if you have this vaccine?

Of course it will, IF the vaccine is effective. If you have the antibodies, the test will detect them. There's no difference between antibodies you get from an infection and antibodies you get from a vaccination. That's why people who have had the hepatitis vaccines can't give blood in the US. They test as if they once had hepatitis, but are no longer infected. And the Red Cross rejects their blood. So, assuming the HIV vaccine worked, the antibody test would be positive, but the test for the virus itself would be negative.

[ghengis]

AIDS on the rise among Asian wives

Sunday 27 June 2004, 17:47 Makka Time, 14:47 GMT

Young married women in Asia have emerged as a fast-growing new group of AIDS sufferers despite remaining faithful to their husbands.

Infection rates are increasing at alarming rates among the group who were once considered at low-risk of infection but have been passed the disease by promiscuous partners, the United Nations and health workers said on Thursday.

In some Asian cultures including Thailand, extra-marital affairs for men are considered the norm while women lack knowledge of birth control and are unable in male-dominated societies to demand that their partner use a condom.

"Young women in this region are generally ill-equipped to protect themselves from the virus," said Lucita Lazo, the UN Women's Fund (UNIFEM) regional programme director for East and Southeast Asia.

Society at risk

"What used to be a disease that is prevalent among so-called high-risk populations ... is now among the low-risk population, and that means average, ordinary, monogamous relationships," she said during a visit to a women's HIV-AIDS shelter on the outskirts of Bangkok.

"I never really thought it would happen to me. I was not promiscuous and I never used drugs. It was my fate"

Lek, HIV-infected woman

"It's not just sex workers, it's normal housewives faithful to their husbands who are picking up the epidemic. It's going into the average household."

Lek, a widow at the shelter, said she was pregnant with her second child when a doctor told her she had contracted the virus.

"I was infected by my husband" four years ago, said the 31-year-old, who said she had been aware of her husband's visits to sex workers but was never able to convince him to use a condom when he had sex with her. He died of an AIDS-related illness soon afterwards.

"He felt remorse, but there was nothing to say because we both felt that we were going to die," said Lek, who used a pseudonym when talking with reporters.

Not me

"I never really thought it would happen to me," she added. "I was not promiscuous and I never used drugs," she said. "It was my fate."

Last year the UN reported a dramatic difference in the number of men and women living with HIV. Globally, some 7.3 million women aged 15 to 24 were HIV positive, compared with 4.5 million young men, according to its figures.

Some 4.5 million young men and 7.3 million women are infected

In Thailand, the highest estimate for HIV prevalence among men is 1.33%, while for women it is two per cent.

UNIFEM's warning comes ahead of the 15th International AIDS Conference which is expected to draw up to 20,000 delegates, including world leaders, to the Thai capital from 11 to 16 July.

It has announced an expansion of programmes focusing on youth and women.

Cultural hurdles

Lazo said cultures in Asia, where women often hold a lower status in society, had significant hurdles to overcome, particularly the imbalance of power between the genders.

"The culture of patriarchy, the culture of silence, the cultural taboos have to be addressed more systematically now," she said.

Women were expected to be virgins for their partners and not supposed to seek out sex education to prevent infection.

Maytinee Bhongsvej, executive director of the Association for the Promotion of the Status of Women (APSW) which runs the women's shelter, said the government needed to take a new approach to fight the disease.

"Unless linkages between HIV and gender relations are better recognised, I think it will be difficult to make progress," she said.

AFP