Original: http://www.lifesite.net/ldn/2007/sep/07092004.html 

February 22, 2007 - Yesterday, Merck announced that it is no longer going to try to persuade states to make its new $360 cervical cancer vaccine mandatory for all pre-teens. (At least, not publicly). The company wouldn’t divulge how much it has spent, to date, on its lobbying campaign.

Virtually everyone has heard about “Gardasil.” Planned Parenthood backs it. Women in Government extols its virtues. (Both organizations receive significant contributions from Merck). Not long ago, a glowing New York Times editorial congratulated Texas governor Rick Perry for mandating “A Vaccine To  Save Women’s Lives.”( So far as I know, Merck makes no contributions to The New York Times, but Perry’s former chief of staff is a Merck lobbyist.) At this point, twenty states have drafted plans to follow Perry’s example.

In the U.S., we already have come close to winning the war on cervical cancer with the $30 Pap smear -- a simple test that has proven remarkably effective. Thanks to screening, between 1955 and 1992 the number of cervical cancer deaths plunged by 74 percent, and the numbers are still shrinking. From 1997 to 2003, deaths fell by an average of 3.8 percent each year. In 2006, it’s estimated that cervical cancer will account for just less than one percent (.65% to be exact) of the anticipated 273,560 cancer deaths among American women.

That said, the numbers suggest that more than 2000 American women could  die of the disease this year—an  unacceptable number. According to a study published in JAMA, most will be women who rarely had Pap smears; a disproportionate share will be poor or members of minorities. But how many of these women are likely to get a $360 vaccine? Rather than contributing billions to Merck’s coffers, we might better take part of that money to launch a campaign to try make sure that every young woman in the U.S. gets in the habit of going for regular Pap smears.

In the emerging world, where Pap smears are not readily available, cervical cancer remains a scourge.  But, in that world, who can afford a $360 vaccine? Last summer, when I asked Merck whether it planned to make the vaccine available at a discount to women in poorer countries, I was told that the question was “premature.” For now, a company spokesperson explained, the company is eying the “118 to 120 million women in the 11 to 26 age range in the U.S., the EU, and other high-income countries.” Merck still hasn’t announced a plan to make Gardasil affordable where it is needed most.

The second point that I tried to highlight last summer is that Merck’s miracle vaccine guards against viruses that account for just 70 percent of all cases of cervical cancer. In the media, Gardasil is usually described as a vaccine that protects against “most” viruses that lead to the cancer. Okay, 70% is more than 50%, so technically, it’s “most,” but the phrase is misleading.

Girls and young women who are immunized still will be vulnerable to the viral strains that account for 30% of all cases of cervical cancer. This is why, as even Merck acknowledges, girls who receive the vaccine still need regular Pap smears.

Meanwhile, a 2003 study published in JAMA points to the danger that “women who are vaccinated [will] perceive themselves to be at low risk for developing cancer and, as a result [will] not participate in screening as recommended.” If they are lulled into a false sense of complacency, the study acknowledges “gains from the vaccination may be offset.” Last week, Bloomberg News reported that in the U.K. health officials have similar concerns .

Less than weeks ago, a report on NBC put flesh on their fears. It featured a young girl in Texas explaining why she is happy to have been vaccinated: “Now this is one cancer I don’t have to worry about fighting.” No one corrected her.

Finally, as Merrill Goozner (author of The $800 Million Pill: The Truth Behind the Cost of New Drugs and director of the Integrity in Science project at the Center for Science in the Public Interest) ) pointed out on Gooznews last Monday, we don’t know much about the possible side effects of the vaccine. Like Merck’s other famous drug, Vioxx, Gardasil  was “fast-tracked” by the FDA. Goozner, who is the father of a 13-year-old daughter, has no plans to have her vaccinated.

In the mainstream media, the only publication that seems to have truly understood, from the outset, what this story is really about is The Wall Street Journal. This is after all, a business story.  As the Journal explained more than three weeks ago: “Mandatory vaccination across the U.S. would make Gardasil an automatic blockbuster for Merck at a time when the patents on some of its bestselling drugs are expiring and it's desperate to replace their revenue streams.”

Meanwhile, the Journal noted, “A growing number of parents are worried about exposing their children to the unforeseen side effects of a new vaccine to protect them from a disease that is no longer very common in the U.S. and often doesn't develop until much later in life. . . . Adding to some parents' concern, 82 adverse events among both teens and adult women have been reported since Gardasil became available last June. . . . Of the more than 25,000 patients who participated in clinical trials of Gardasil, only 1,184 were preteen girls. ‘That's a thin base of testing upon which to make a vaccine mandatory,’ says Barbara Loe Fisher, co-founder of the National Vaccine Information Center, an advocacy group that lobbies for safer vaccines. . . Merck declined to say how much money it has funneled into its lobbying campaign, or contributed to Women in Government,” the Journal reported..  “A spokeswoman for Women in Government, Tracy Morris, declined to say how much it had received from Merck.” 

The campaign to vaccinate every girl and young women in the U.S. is not about saving women’s lives. It is, as the Journal so clearly understands, about money. It is about Merck’s desperate need to replace the revenue that it lost when it was forced to pull Vioxx off the market.  Some call Gardasil the “Help Merck Pay For Vioxx Vaccine.”

Finally, Merck’s campaign stands as an example of a for-profit corporation trying to set healthcare spending priorities for the nation. This is not Merck’s job.

source 

Children given a flu vaccine by nasal spray were better protected against the disease than those given the old shot in the arm, according to new research in the most recent New England Journal of Medicine.

The study, which followed nearly 8,500 children in 16 countries, found the vaccine sniffed up the nose reduced the influenza "attack rate" in children by 55 percent compared to the traditional injections.

The attack rate is the number of people who get sick compared to the total number of people in a study group.

"Children get the flu twice as often as adults," said Dr. Robert Belshe of St. Louis University, the study's lead author. "It's important to vaccinate kids against influenza -- and to identify new and more effective flu vaccine options -- because kids have a higher attack rate for influenza infection than adults."

The study, funded by MedImmune, which makes the FluMist nasal spray vaccine, is the largest of its kind ever done.

Abdominal aneurysms

Enzyme discorvery may lead to remedy

Researchers at Washington University hope a new discovery will lead to a radically new treatment for potentially fatal abdominal aortic aneurysms.

Those aneurysms are weak spots in the wall of the body's main artery that can dilate over time. If that weak spot suddenly ruptures, death comes quickly. Currently, surgery is the only treatment once an aneurysm is found.

But the St. Louis researchers have found a key enzyme that that triggers chronic inflammation in the aorta, promoting the growth of an aneurysm. By finding a drug that acts on that enzyme, doctors hope that they can prevent small aneurysms from enlarging to the point where they require a surgical fix.

"We think DPPI (dpeptidyl peptidase I) is a viable therapeutic target that may keep the growth of aortic aneurysms in check, so they don't become life-threatening," said Dr. Robert Thompson, one of the senior researchers.

Already, Thompson and his colleagues have found that specially bred mice which lack DPPI do not develop aortic aneurysms.

When Isaac Daniel was informed by his son's school that the 8-year-old was missing, Dad was understandably frantic.

Fortunately, by the time he cut short his business trip in New York to fly back to Atlanta, he found that it had all been a miscommunication. But it immediately led to a brilliant idea: Designing tennis shoes that come with a Global Positioning Satellite (GPS) chip.

Next month, a line of adult sneakers called Quantum Satellite Technology, are expected to hit store shelves. They come with a hefty price tag of $350, but they promise to locate the wearer anywhere in the world with the press of a button. A children's line expected to be added this summer.

The sneakers work when the wearer presses a button on the shoe to activate the GPS chip. A wireless alert detailing the location is sent to a 24-hour monitoring service that costs an additional $20 a month. In some emergencies, a parent, spouse or guardian can call the service as well.

Don't worry, teens -- parents can't call the service just to check up on you. If they do, they'll incur all law enforcement costs.

Lonely individuals may be twice as likely to develop the type of dementia linked to Alzheimer's disease as those who are not lonely, according to this month's issue of the Archives of General Psychiatry.

Researchers at Rush University in Chicago analyzed the association between loneliness and Alzheimer's in 823 people with an average age of 80.7. Assessing loneliness on a scale of one to five, they found that the risk for developing Alzheimer's increased approximately 51 percent for each point higher they were on the loneliness score.

The link between loneliness and Alzheimer's, however, is unclear. Loneliness was not associated with the characteristic brain plaques or "tangles" associated with Alzheimer's disease.

"In human beings, loneliness has been associated with impaired social skills," the study suggested. "Thus, neural systems underlying social behavior might be less elaborated in lonely persons and, as a result, be less able to compensate for other neural systems compromised by age-related (disease)."

There might be good news in the offing for frequent fliers: Scientists in California and Michigan say they are getting closer to a machine that will screen airline passengers for explosive, chemical and biological threats at the same time.

In previous research, George R. Farquar and his colleagues tested the effectiveness of a system that could detect chemical and biological agents. The new research includes several kinds of explosives that have been used worldwide in improvised explosive devices (IEDs) and other terrorist attacks.

They say the new scanner has the potential to detect the presence of explosives even if only one dust-speck-sized particle weighing one trillionth of a gram.

When it comes to heart disease, you may be smarter than your doctor -- and that's not necessarily a good thing.

A new study by the California Pistachio Commission found that 59 percent of women and 44 percent of men know that heart disease is the leading cause of death among women. Moreover, 27 percent of women said they feel protected against heart disease because they see their doctor regularly.

But that trust may be misplaced. According to an American Heart Association study from 2005, only 8 percent of primary care physicians and 17 percent of cardiologists knew that heart disease kills more women than men.

"Perhaps today's physicians are more aware about the issue since the AHA study was published two years ago, but millions of at-risk women are relying on their doctor to know ALL the facts about women's heart disease," said Dr. Susan Bennett, president of the Association of Women's Heart Programs.

"There needs to be more of an emphasis on reaching the medical community with the message of prevention and treatment."

In the meantime, the new study showed half or more of the 1,000 women questioned were watching their diet, exercising and not smoking. Still, 32 percent said they had high blood pressure and 28 percent had high cholesterol, risk factors for heart disease.

Putting the squeeze on milk may be the long-sought solution to killing bacteria and increasing the beverage's shelf life without introducing unwanted flavors.

Michael Qian at Oregon State University says ultrahigh-temperature pasteurization (UHT) does produce milk that stays fresh at room temperature for six months. However, the process leaves a "cooked" flavor that has limited its popularity in the United States.

Now, in experiments published in a recent Journal of Agricultural and Food Chemistry, Qian and his colleague describe how high hydrostatic pressure processing (HPP) can crush bacteria without affecting flavor.

"Milk processed at a pressure of about 85,000 pounds per square inch for five minutes, and lower temperatures than used in commercial pasteurization, causes minimal production of chemical compounds responsible for the cooked flavor," they reported. "HPP gives milk a shelf life at refrigerated temperatures of at least 45 days."

Source: BelleVille News-Democrat

A new powdered form of BCG, the tuberculosis vaccine, mixes a mycobacterium [green] with leucine [gray] and may pave the way for more powerful, needle-free forms of the vaccine.

A new powdered form of tuberculosis (TB) vaccine may help save some of the nearly two million lives lost to the disease annually. In preliminary tests, the powdered form contained more active bacterial cells than a freeze-dried version similar to the existing vaccine. The result may pave the way for health workers to administer the vaccine as an aerosol to the lungs instead of as an injection, possibly leading to a more effective treatment.

"This is a very important technological advance," says immunologist Stefan Kaufmann of the Max Planck Institute for Infection Biology in Berlin, who was not involved in the study. "It will allow needle-free administration of BCG, which is particularly important for developing countries."

The BCG vaccine, which health workers administer to 100 million infants annually, consists of a weakened mycobacterium from cows that is related to the human TB mycobacterium. Researchers believe that the vaccine saves 40,000 to 100,000 lives annually by preventing the spread of TB from the lungs to the brain and other organs. But BCG is freeze-dried much like instant coffee, which damages the mycobacteria and creates particles that are too big to be inhaled. Researchers suspect than an inhalant vaccine would be more effective, because "tuberculosis is primarily a disease of the lung," Kaufmann says.

In an attempt to create such a product, Sadoff and his colleagues turned to a method called spray-drying, used to make powdered milk. In spray-drying, a mixture of water and the material to be dried is forced through a sprinkler into a high-temperature drum, instantly evaporating the water droplets clinging to the material.

The researchers found that 50 percent of the BCG mycobacteria survived the spray-drying process, compared with 5 percent when the same solution was freeze-dried, according to a paper published online recently by the Proceedings of the National Academy of Sciences USA.

"By having less damage in the dried form we should have a better vaccine," says bioengineer David Edwards of Harvard University, a co-author of the report. He adds that spray-drying would be simpler and cheaper to implement on large scales than freeze-drying.

The BCG vaccine has over the decades lost its effectiveness against TB lung infections, the most common form of the illness. "Why it doesn't work anymore is a mystery—a big mystery," Sadoff says. Part of the problem, he says, may be BCG's old-fashioned manufacturing process, including the freeze-drying step, so incorporating spray-drying may help introduce a more effective vaccine.

Sadoff says clinical tests of spray-dried BCG could begin as soon as late 2008, when his group plans to conduct mid-stage trials of several new forms of the vaccine. Edwards adds that the South African NGO Medicine in Need has begun implementing the manufacturing tools for spray-drying.

Source: Scientific American

In recent news, however, the adequacy of the warning label provided by the Center for Disease Control has been tested by the public, as numerous complaints of side effects have surfaced after patients received their HPV vaccinations.

As of now, a report has stated that over 500 people have complained of post-vaccination side effects such as fainting and dizziness, and there have been three recorded cases of the Guillain-Barré syndrome. According to health professionals, the syndrome is a rare disorder within the nervous system that sometimes causes complete paralysis.

Dr. Michelle Famula, program director at the Cowell Student Health Center, said at UC Davis there have been approximately 200 shots of the cervical cancer vaccine given out to patients that have not yet caused concern.

"Whenever anyone asks us about the vaccine, we tell them it has tremendous efficacy and antibody results," Famula said. "We follow the initial practices as are approved by the CDC and if there is ever a problem or concern about its safety, we respond appropriately."

Adrienne Wonhof, assistant director at the UC Davis Women's Resources and Research Center, said the staff is glad such a vaccine has been developed to prevent HPV and cervical cancer.

"We encourage campus women to visit [the health center] or their doctor to determine if it's appropriate for them," Wonhof said. "We also hope the cost for the vaccine will allow for women in all income groups to get vaccinated if they choose."

Stephanie Nuccitelli, student coordinator for the Health Education and Promotion on-campus internship, said she thinks it is important for a vaccine to be tested for its safety and the seriousness of its side effects.

"The HPV vaccine is a great tool for students to be able to protect themselves from cervical cancer and genital warts," Nuccitelli said. "However, they must realize that it only protects against certain strains of the HPV virus, so using condoms and getting tested for STIs is still very important."

CDC officials plan to further discuss the health effects of women who opt for the vaccine and how it should be further advertised and distributed at an observance in Atlanta focused solely on women's health issues from now through Apr. 6.

"We definitely recommend the vaccine to women who come in to see us," Famula said. "The vaccine is approved for women ages 9 to 26, but if other people wish to have it, we can still immunize them. We also try to educate those who have probably not yet had exposure to the virus - those who are not yet sexually active."

Hepatitis E is a liver disease caused by the hepatitis E virus, which spreads through contaminated food or water.

Hepatitis E is rare in the U.S., but it's a major public health problem in developing countries. The disease is most dangerous for pregnant women, who can die or have miscarriages or stillbirths due to hepatitis E.

Hepatitis E Vaccine Test

The vaccine study was conducted in Kathmandu, Nepal. Participants were 1,794 soldiers in Nepal's army.

Virtually all participants (99%) were men. No pregnant women took part.

None of the soldiers had previously contracted hepatitis E, but they were at high risk for hepatitis E infection, note the U.S. and Nepalese army experts who designed the study.

They included Mrigendra Prasad Shrestha, MBBS, of the U.S. Walter Reed-Armed Forces Research Institute of Medical Sciences Research Unit Nepal.

Half of the soldiers got three shots of the vaccine; the other half of the group got three sham shots (placebo). They were followed for the next six months.

Preventing Hepatitis E

During the six-month study, 69 participants developed hepatitis E. All but three of them had received the placebo shot, not the hepatitis E vaccine.

In people who got all three doses of the hepatitis E vaccine, the vaccine was 95% effective, the study shows.

Side effects were similar in both groups, though injection-site reactions were more common in the vaccine group. Infections (not including hepatitis E) accounted for most side effects, the study shows.

The vaccine's effectiveness and side effects beyond six months aren't yet clear.

The results are "encouraging," but the vaccine should be studied in pregnant women, children, and teens, writes editorialist Krzysztof Krawczynski, MD, PhD, of the CDC.

The vaccine may also be useful for people traveling from developed countries to areas where the hepatitis E virus is common, notes Krawczynski.

The study was funded by the drug company GlaxoSmithKline, which makes the vaccine and is a WebMD sponsor.

source WebMD

In the second treatment year, Grazax reduces hay fever symptoms by 44 pct and reduces the need for symptom-relieving medication by 73 pct compared with placebo, ALK Abello said.

ALK Abello said it has recently entered strategic alliances for the Grazax programme with the Menarini Group for some European markets and with Schering-Plough (nyse: SGP - news - people ) for North America..

Copyright AFX News

But medical groups, politicians and parents began rebelling after disclosure of a behind-the-scenes lobbying campaign by Gardasil's maker, Merck & Co., to get state legislatures to require 11- and 12-year-old girls to get the three-dose vaccine as a requirement for school attendance.

Some parents' groups and doctors particularly objected because the vaccine protects against a sexually transmitted disease, human papilloma virus, which causes cervical cancer. Vaccines mandated for school attendance usually are for diseases easily spread through casual contact, such as measles and mumps.

"Our goal is about cervical cancer prevention, and we want to reach as many females as possible with Gardasil," Dr. Richard M. Haupt, Merck's medical director for vaccines, told The Associated Press.

"We're concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts," Haupt said, adding the company will continue providing information about the vaccine if requested by government officials.

Whitehouse Station-based Merck launched Gardasil, the first vaccine to prevent cervical cancer, in June. It protects against the two virus strains that cause 70 percent of cervical cancer and two strains that cause most genital warts.

Sales totaled $235 million through the end of 2006, according to Merck.

Last month, the AP reported that Merck was channeling money for its state-mandate campaign through Women in Government, an advocacy group made up of female state legislators across the country.

Conservative groups opposed the campaign, saying it would encourage premarital sex, and parents' rights groups said it interfered with their control over their children.

Even two of the prominent medical groups that supported broad use of the vaccine, the American Academy of Pediatricians and the American Academy of Family Practitioners, questioned Merck's timing, Haupt said Tuesday.

"They, along with some other folks in the public health community, believe there needs to be more time," he said, to ensure government funding for the vaccine for uninsured girls is in place and that families and government officials have enough information about it.

Legislatures in roughly 20 states have introduced measures that would mandate girls have the vaccine to attend school, but none has passed so far. However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring Texas girls entering the sixth grade as of 2008 get the vaccinations, triggering protests from lawmakers in that state. Parents there could opt out for their daughters if they state religious or philosophical objections, but several Texas lawmakers want to have parents opt in instead of opting out.

Perry defended his order Tuesday, a day after lawmakers in Austin held a lengthy hearing on the issue but failed to act on a bill to override the order.

Dr. Anne Francis, who chairs an American Academy of Pediatrics committee that advocates for better insurer reimbursement on vaccines, called Merck's change of heart "a good move for the public."

"I believe that their timing was a little bit premature," she said, "so soon after (Gardasil's) release, before we have a picture of whether there are going to be any untoward side effects."

Given that the country has been "burned" by some drugs whose serious side effects emerged only after they were in wide use, including Merck's withdrawn painkiller Vioxx, Francis said, it would be better to wait awhile before mandating Gardasil usage.

She said she also was concerned about requiring a vaccine for a disease that is not communicable and so does not have a big public health impact. While doctors expect Gardasil to have a huge effect in poor countries where women do not get Pap smears, in this country those tests limit the incidence of cervical cancer to about 9,710 new cases and 3,700 deaths each year.

The National Vaccine Information Center has been publicizing reports of side effects -- mostly dizziness and fainting -- in several dozen people getting Gardasil, which is approved for use in females ages 9 to 26. The center, a group of parents worried that vaccines harm some children, questions whether the vaccine was tested in enough young girls.

Officials with the Centers for Disease Control and Prevention, however, say that reports of side effects through the end of January don't raise any red flags.

The vaccine also is controversial because of its price -- $360 for the three doses required over a six-month stretch. Because of that cost and what pediatricians and gynecologists say is inadequate reimbursement by insurers, many are choosing not to stock the vaccine or requiring surcharges to administer it, increasing the cost for many families and making the vaccine hard to come by.

Merck shares fell 37 cents to $44.13 in after-hours trading Tuesday after rising 22 cents to close at $44.50 on the New York Stock Exchange.

Merck & Co.: http://www.merck.com

source - AP 

source SABC News 

Jacinta Julia Adams Fernández, a mother of three, is one of 175 Dominican prostitutes lending their bodies to a trial of what New Jersey-based Merck & Co. hopes will prove to be a vaccine against the virus that causes AIDS.

Since turning to prostitution after a divorce 13 years ago, Adams has seen friends and co-workers die from the disease. Prostitution is illegal but widespread, largely ignored by the authorities.

At least 70,000 of the Dominican Republic's 9 million people are HIV-positive, and discrimination discourages many from seeking testing or treatment. Among prostitutes, about 3.6 percent are infected, although researchers report rates as high as 12 percent in some areas.

PLENTY OF VOLUNTEERS

The prostitutes, who will spend much of the next four years traveling to Santo Domingo for injections and checkups, were recruited from brothels across the country. They are among some 3,000 people in eight countries testing the experimental vaccine -- a combination of deactivated cold viruses and synthetically produced HIV genes meant to train the body to destroy infected cells.

Any long-term risks will take years to discover, but once doctors explained there was no way to contract the disease from the vaccine, they found plenty of volunteers at Adams' brothel in Las Guaranas, a town of dirt streets and low-slung houses surrounded by rice fields about 75 miles north of Santo Domingo.

Many were turned away because of pregnancy, conditions such as high blood pressure or because they are already infected.

Participants don't know whether they are getting the drug or a placebo. Even if the results are promising, a vaccine would be several years away from the marketplace.

The program pays the women's meals, transportation and $30 for a lost day's work. The clinic provides health training and occasional gifts like bags of cosmetics to keep others from losing interest.

Participants get three injections over their first seven months in the study, and then must keep reporting back for four years of close monitoring.

For many, the greatest reward is pride: ''We are doing it for the world,'' said 38-year-old Lucila Mendoza Ovalle.

The other test sites -- Haiti, United States, Australia, Brazil, Canada, Jamaica and Peru -- all have the same strain of HIV, said Merck spokeswoman Janet Skidmore. The strain is also found in Europe, meaning a formula that works here could find a lucrative global market. A trial was launched Thursday in South Africa to see if the vaccine would have any effect on African strains.

MERCK TRIAL

The Merck trial, currently in the second of three testing phases -- each of which is to last several years -- is one of 17 sponsored by the HIV Vaccine Trial Network, a Seattle-based group supported by the U.S. government.

The trial is ''is an extremely important step, but not the only one,'' said Dr. Jorge Flores, chief of vaccine research for the AIDS division at the U.S. National Institute of Allergy and Infectious Diseases. He stressed the importance of education and research into other strategies, like microbicides in vaginal gels. Even a vaccine that reduces the level of HIV in future infections would be a victory.

''A 90 percent, 80 percent reduction is going to be acceptable for the time being,'' said Dr. Ellen Koenig, who heads one of two Santo Domingo clinics testing the formula.

Margarita Ramírez de los Santos, 24, said she volunteered after her brother and sister-in-law died of AIDS.

''I am worried about my health,'' she said.

source Miami Herald 

In animal tests, the vaccine did not protect monkeys against infection with an AIDS virus. But vaccinated animals remained healthy -- and suffered no immune damage from the deadly virus.

Now, nine humans have received small doses of the vaccine: about one-tenth of the full dose. The vaccine was safe. And even at this tiny dose, it stimulated the kind of immune responses that protected monkeys.

The vaccine is the brainchild of Harriet Robinson, MD, chief of microbiology and immunology at Yerkes National Primate Research Center. Robinson is chief scientific advisor to GeoVax Labs Inc. of Atlanta, spun off from Emory University's vaccine center to market the vaccine.

Michael Keefer, MD, professor of medicine at the University of Rochester, New York, helped test the vaccine through the NIH-sponsored HIV Vaccine Trials Network, for which he is associate director for scientific administration.

"We are very encouraged with Dr. Robinson's approach," Keefer tells WebMD. "She has some of the strongest data in her animal models as anyone. And the results look pretty good from this, the very earliest human trial of the vaccine."

AIDS Vaccine From Smallpox Vaccine

It's a two-part vaccine. First, a person gets two doses of a DNA vaccine carrying three important HIV genes called env, gag, and pol. Then a person gets two doses of a smallpox virus genetically engineered to carry the same three HIV genes.

The smallpox component of the vaccine makes it unique. The virus, called the modified Ankara virus or MVA, cannot replicate in humans and cannot cause disease. It was used in the waning days of the successful global smallpox eradication program to safely vaccinate some 120,000 people in Germany.

A side benefit of the GeoVax vaccine is that recipients will become immune to smallpox, should that virus return via bioterror attack or lab accident.

But the main reason for using the smallpox virus is that it is one of the most powerful stimulators of immunity known to man. And it seems that when the virus carries HIV genes, those powerful immune responses transfer to HIV as well.

AIDS Vaccine in 4 Years?

There are two basic kinds of immunity. Cell-based immune responses depend on killer blood cells that seek out and destroy infected cells. Antibody-based immune responses depend on antibodies that stick to germs or infected cells, inactivating them and marking them for destruction.

The GeoVax vaccine is designed to stimulate both kinds of immunity. The immune responses seen with one-tenth doses of the vaccine were cell-based responses. However, Robinson says she also expects to see anti-HIV antibodies in volunteers to get the full dose of the vaccine.

That study already is under way. Thirty volunteers are getting the full dose of the vaccine while six get mock injections. Results of that study should be known later this year.

Meanwhile, Robinson and colleagues are gearing up for a phase II study of the vaccine, which will involve hundreds of HIV-negative volunteers. Because of the promising phase I results, that trial has been moved up by a year and a half, Robinson says.

"The fact we are getting such good immune responses in humans is very encouraging," Robinson says. "We are moving forward, and if everything really goes absolutely smoothly, we could have a vaccine in four years."

That could happen, although in real-life vaccine and drug development, things rarely go so perfectly.

Two similar vaccines -- using adenovirus instead of smallpox virus -- are further along than the GeoVax vaccine.

Drug giant Merck has a genetically engineered adenovirus vaccine that carries elements of the HIV gag, pol, and nef genes. That vaccine is being tested in some 3,000 people at high risk of infection in the U.S. and Africa.

The National Institutes of Health also has a genetically engineered adenovirus vaccine, carrying the HIV env, gag, and pol genes, which is used to boos