News (Updated September 27, 2009)

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In a first, an AIDS vaccine shows some success

By MARILYNN MARCHIONE, AP Medical Writer Marilynn Marchione, Ap Medical Writer Fri Sep 25, 2009

Scientists and government leaders have already started mapping out how to try to improve the world's first successful AIDS vaccine, which protected one in three people from getting HIV in a large study in Thailand .

That's not good enough for immediate use, researchers say. Yet it is a watershed event in the 26 years since the AIDS virus was discovered. Recent setbacks led many scientists to think a successful vaccine would never be possible.

The World Health Organization and the U.N. agency UNAIDS said the results "instilled new hope" in the field, even though it likely will be years before a vaccine might be widely available.

"This is truly a great moment for world medicine," said Lt. Gen. Eric Schoomaker, the U.S. Army Surgeon General. The Army helped sponsor the study, the world's largest of an AIDS vaccine.

It was the first time scientists tried preventing HIV the same way they treat it — with a combination approach. The study used two vaccines that work in different ways, and that may be one reason the strategy worked, even though neither vaccine did when tested individually in earlier trials, scientists say.

The combo cut the risk of becoming infected with HIV by more than 31 percent in the study of more than 16,000 volunteers in Thailand , researchers announced Thursday in Bangkok .

That benefit is modest, yet "it's the first evidence that we could have a safe and effective preventive vaccine," said Col. Jerome Kim, an Army doctor who helped lead the study.

The outcome "gives me cautious optimism about the possibility of improving this result" and developing a more effective AIDS vaccine, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which co-sponsored the study.

"It's an opening of a new gateway to a road that has brighter lights in it now and maybe some directions," he said. "We need to bring the best minds together and map the way forward."

That has already started. Dozens of researchers, vaccine makers and deep-pocket donors will meet next week in New York "to talk about where we go from here," said Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise, an alliance of government officials, AIDS scientists, funders such as the Bill & Melinda Gates Foundation, and the WHO. At the meeting will be researchers from the Thai trial, the Army and independent scientists.

Scientists around the world cheered the first taste of victory.

"Since the 1980s, we've been hearing we're going to have an AIDS vaccine in 10 years. For the first time in my lifetime, it feels as though we're actually getting on the right track," said Josh Ruxin, a Columbia University public health specialist who runs the Access Project, which helps health centers provide AIDS care in Rwanda.

The Thailand Ministry of Public Health conducted the study. The U.S. Army has long worked with the Thai government and others to develop and test vaccines and medicine to protect troops and the general public.

The study used strains of HIV common in Thailand . Whether such a vaccine would work against other strains in the U.S. , Africa or elsewhere in the world is unknown, scientists stressed.

Even a marginally helpful vaccine could have a big impact. Every day, 7,500 people worldwide are newly infected with HIV; 2 million died of AIDS in 2007, UNAIDS estimates.

The study tested the two-vaccine combination in a "prime-boost" approach, in which the first one primes the immune system to attack HIV and the second one strengthens the response.

They are ALVAC, from Sanofi Pasteur, the vaccine division of French drugmaker Sanofi-Aventis; and AIDSVAX, originally developed by VaxGen Inc. and now held by Global Solutions for Infectious Diseases, a nonprofit founded by some former VaxGen employees.

ALVAC uses canarypox, a bird virus altered so it can't cause human disease, to ferry synthetic versions of three HIV genes into the body. AIDSVAX contains a genetically engineered version of a protein on HIV's surface. The vaccines are not made from whole virus — dead or alive — and cannot cause HIV.

The study tested the combo in HIV-negative Thai men and women aged 18-30 at average risk of becoming infected. Half received four "priming" doses of ALVAC and two "boost" doses of AIDSVAX over six months. The others received dummy shots. No one knew who got what until the study ended.

Participants volunteered for the study and were told about the potential risks associated with receiving the experimental vaccine before agreeing to participate.

All were given condoms, counseling and treatment for any sexually transmitted infections, and were tested every six months for HIV. Any who became infected were given free treatment with antiviral medicines. All participants continued to receive an HIV test every six months for three years after vaccinations ended.

The results: New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 percent lower risk of infection for the vaccine group. Two of the infected participants who received the placebo died.

Scientists don't know why the vaccine combo worked. It was the Army's idea to test the combination, said Dr. Donald Francis, a former government scientist who helped identify HIV as the cause of AIDS and now heads the nonprofit that holds the rights to AIDSVAX.

AIDSVAX is aimed at prompting antibodies to HIV. The Sanofi vaccine spurs cells to attack the virus directly. The combo strategy "bridges the two major arms of the immune system," Francis said.

Scientists need to look at blood samples from study participants to understand why some became infected and others were protected.

"With the limited amount of vaccine we have right now, we've got a small number of studies that we could do," Francis said.

Sanofi officials said the same. The company's Dr. Sanjay Gurunathan said a series of studies "that will take a few years" are planned to see if the vaccine can be improved for licensing, and whether new components should be considered to boost effectiveness.

Even AIDS advocates agreed more research was needed.

"We need to take a deep breath and look at all the available evidence from this trial" before urging that this vaccine be used now, said Julie Davids, a spokeswoman for the Community HIV/AIDS Mobilization Project, a New York-based prevention advocacy group.

The study was done in Thailand because U.S. Army scientists did pivotal research in that country when the AIDS epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers. The Thai government also strongly supported the idea of doing the study.

Thailand had a burgeoning AIDS problem when the study began. Aggressive prevention efforts have dramatically cut the rates of new infections there, and only 125 infections occurred in the entire study of more than 16,000 people.

Scientists want to know how long the vaccine's protection will last, whether booster shots will be needed, and whether the vaccine helps prevent infection in gay men and injection drug users, since it was tested mostly in heterosexuals in the Thai trial.

The vaccine had no effect on HIV levels in the blood for those who did become infected. That had been another goal of the study — seeing whether the vaccine could limit damage to the immune system and help keep infected people from developing full-blown AIDS.

That is "one of the most important and intriguing findings of this trial," Fauci said. It suggests the signs scientists have been using to gauge whether a vaccine was actually giving protection may not be valid.

"It is conceivable that we haven't even identified yet" what really shows immunity, which is both "important and humbling" after decades of research, Fauci said.

Volunteers key to success of Thai vaccine trials

By AMBIKA AHUJA AND MICHAEL CASEY, Associated Press Writers Ambika Ahuja And Michael Casey, Associated Press Writers

NONGTAPAN, Thailand – Nearly 16,000 Thais ignored the false rumors that they were being infected by the AIDS virus, and overcame their fears of becoming social outcasts to participate in trials of the first vaccine found to prevent infection with the deadly virus.

Many of the volunteers — an eclectic mix of housewives, fishermen, factory workers, laborers and even prostitutes — saw first hand how the disease ravaged this region of plantations and industrial estates in southeast Thailand, and they wanted to do their part to end the epidemic that kills millions worldwide each year.

"In the 80s, the coffin business was booming around here. It was one family, after another," said Tanad Yomaha, a volunteer whose sister and brother-in-law died of AIDS. "The temple here had at least one cremation ceremony every night and people were in perpetual mourning."

Their quiet dedication — 90 percent of the volunteers stuck with the trial for over six years — paid off when American and Thai authorities announced Thursday that the experimental vaccine had been found to prevent infection with the AIDS virus, an unexpected result that many scientists thought would never be possible.

The vaccine was shown to cut the risk of HIV infection by more than 31 percent, and while the vaccine did not meet the researchers' goal of 50 percent, it could still have a big impact. Every day, 7,500 people worldwide are newly infected with HIV; 2 million died of AIDS in 2007, the U.N. agency UNAIDS estimates.

Soon after the trials started, Kim said volunteers heard whispering neighbors say the vaccine contained HIV and that the U.S. Army — which sponsored the study with the National Institute of Allergy and Infectious Diseases — was using a vaccine too dangerous to test in the United States .

Some even complained they risked losing their girlfriends or jobs after word spread they were participating in the trials.

"I was scared I would become a guinea pig and that they would inject us with AIDS," said Saichon Booncharoen, a 36-year-old, who later became a volunteer and helped recruit other participants.

The volunteers, however, said their initial doubts subsided when they learned the vaccine was not made from whole virus — dead or alive — and cannot cause HIV. Ministry health workers educated potential volunteers about the vaccine and AIDS, and researchers worked with communities to stamp out rumors and misinformation.

"I spoke to my parents and local doctors and thought about it for months," Saichon said. "Eventually, I decided I wanted to do this to be a part of something bigger, something beyond myself."

The study was conducted by the Thai Ministry of Public Health, which used strains of HIV common in Thailand . Scientists stressed, however, that it was unknown whether the vaccine would work against other strains found in places like the U.S. or Africa .

The study tested a two-vaccine combo in a "prime-boost" approach, where the first one primes the immune system to attack HIV and the second one strengthens the response.

The first, named ALVAC, is made by Sanofi Pasteur, the vaccine division of French drugmaker Sanofi-Aventis, and the second is AIDSVAX, originally developed by VaxGen Inc. and now held by Global Solutions for Infectious Diseases, a nonprofit founded by former VaxGen employees.

Col. Jerome Kim, who helped lead the study for the U.S. Army, said researchers settled on Rayong and Chonburi provinces because they had slightly higher rates of HIV than other parts of Thailand and a relatively stationary population.

The study tested the combination in HIV-negative men and women ages 18 to 30 who were in good health and at average risk of becoming infected. They were counseled against having unsafe sex or intravenous drug use and were allowed to drop out at any time. No other conditions or limitations applied.

Half received the vaccine combination and others received placebo shots. No one knew who got what.

"We enrolled people irrespective of where they worked and what they did," said Kim, who oversaw the trials for four years in Thailand with the Armed Forces Research Institute of Medical Sciences. "It is a true representation of the people who live and work there."

Saichon was typical of most volunteers who signed up for altruistic reasons, rather than the 300 ($9) to 500 baht ($15) for each clinic visit, Kim said.

"They looked on this as a patriotic thing," Kim said. "To us, it seemed quite a noble notion."

Health workers tracked the volunteers with regular phone calls and house visits. They also organized community health forums and established volunteer groups that allowed participants to bond over trips to the beach or activities like cleaning temples.

"It is something very uniquely Thai. Everyone does everything together," Kim said. "It's a lot of social mobilization which would be difficult to do in the United States ."

The trials may be over but many participants say they formed lasting bonds over the past six years.

"We are still doing volunteer work together, taking trips together and going out together," Tanad said. "Now, we are having problems with landfills and garbage dumping in the area so we are brainstorming about what to do next to keep our village unharmed."

Top US official on disease hails breakthrough AIDS study

Thu Sep 24, 2009

WASHINGTON (AFP) - The head of the US agency tasked with controlling the spread of infectious disease on Thursday hailed as an important breakthrough a new AIDS vaccine that reduces the risk of HIV infection by one-third.

"These new findings represent an important step forward in HIV vaccine research," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, which provided major funding and logistical support for the study.

"For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals," he said in a statement.

"Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field," he said.

The experimental AIDS vaccine was tested on 16,000 volunteers, the world's largest medical trial, carried out by the United States Army and Thailand 's Ministry of Public Health.

The vaccine was tested on volunteers -- all HIV negative men and women aged from 18 to 30 -- at average risk of infection in two Thai provinces near Bangkok starting in October 2003.

Half received the vaccine and the rest were given a placebo. Out of the placebo recipients 74 of 8,198 became infected compared with 51 of 8,197 who got the vaccine.

The breakthrough comes after years of fruitless attempts by the medical world to find an HIV vaccine.

KENYA : "My life revolved around alcohol and women"

Source: IRIN

BUSIA, 21 September 2009 - Alloys Emokori, 55, is a recovering alcoholic in the western Kenyan town of Busia , near the Kenya-Uganda border. Diagnosed with HIV in 2004, Emokori has lost five wives. He told IRIN/PlusNews about his battle to overcome alcoholism.

"My life revolved around alcohol and women. Due to alcohol, I lost four women who left because they could not tolerate my drinking; another of my wives died of HIV. Some of my wives also drank, and we would fight all day. For one of my wives, we were even competing in drinking and sleeping around. She had her lovers and I had my own.

"Today I am alone, taking care of the children my wives left behind.

"It was only when I became too sick to even walk that my children decided to take me to the hospital by force. I was told that I had HIV, but still I lived in denial.

"A friend eventually convinced me to start taking antiretroviral drugs and I agreed. But then as soon as I started feeling well, I relapsed back to heavy drinking and even abandoned the medicine. My health deteriorated badly. The community health workers helped and they made sure I was put on drugs again.

"One of my old drinking buddies who had abandoned booze and joined an alcohol counselling group would come to talk to me about joining the group. He never gave up, even following me to the pub, until I succumbed to his persuasions and joined him in one of the counselling sessions.

"With time I stopped drinking and became more dedicated to the counselling sessions - it has helped me a great deal. Today I counsel people on the dangers of drinking - and more so those who are like me, living with HIV.

"For those who knew me, I am testimony that alcoholism or drug abuse and HIV cannot share a bed. If they do, then they will conspire to kill you very fast.

"I look back at what alcoholism has done in my life and thank God for today, because my life could have turned [out] worse... at least I still live and care for my children."

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