By Dr. James Kublin

Today, December 1st, is World AIDS Day, and to mark the occasion the HIV Vaccine Trials Network, which is headquartered at Fred Hutchinson Cancer Research Center in Seattle, would like to debunk the top 10 myths about HIV vaccine research.

Myth No. 1: HIV vaccines can give people HIV.

HIV vaccines do not contain HIV and therefore a person cannot get HIV from the HIV vaccine. Some vaccines, like those for typhoid or polio, may contain a weak form of the virus they are protecting against, but this is not the case for HIV vaccines. Scientists make HIV vaccines so that they look like the real virus, but they do not contain any HIV. Think of it like a photocopy: It might look similar, but it isn’t the original. In the past 25 years more than 30,000 volunteers have taken part in HIV vaccine studies worldwide, and no one has been infected with HIV by any of the vaccines tested – because they do not contain HIV.

Myth No. 2: An HIV vaccine already exists.

There is no licensed vaccine against HIV or AIDS, but scientists are getting closer than ever before to developing an effective vaccine against HIV. In 2009, a large-scale vaccine study conducted in Thailand called RV144 showed that a vaccine combination could prevent about 32 percent of new infections. Researchers are starting to understand why this vaccine combination worked and how to improve upon it.

Researchers around the world continue to search for an HIV vaccine that is even more effective. Leading this effort is the HIV Vaccine Trials Network, the largest publicly funded group of HIV vaccine researchers in the world. The HVTN is an international effort to find a safe and effective vaccine to stop the spread of HIV. It is funded by the U. S. National Institutes of Health.

Myth No. 3: Joining an HIV-vaccine study is like being a guinea pig.

Unlike guinea pigs, people can say yes or no to participating in research. All study volunteers must go through a process called informed consent that ensures they understand all of the risks and benefits of being in a study, and those volunteers are reminded that they may leave a study at any time without losing rights or benefits. The HVTN takes great care in making sure people understand the study fully before they decide whether or not join. All HVTN research adheres to U.S. federal regulations on research, as well as the international standards for the countries in which it conducts research.

Myth No. 4: A person must be HIV positive to be in an HIV vaccine study.

Not so. While some research groups are conducting studies of vaccines that might be used in people who are already infected with HIV, the vaccines being tested by the HVTN are preventive vaccines. They must be tested on volunteers who are not infected with HIV.

Myth No. 5: Vaccine researchers want study participants to practice unsafe behaviors so they can see whether the vaccine really works.

Not true. The safety of study participants is the No. 1 priority of HIV vaccine researchers and study site staff. Trained counselors work with study participants to help them develop an individual plan on how to keep from contracting HIV. Participants also are given supplies such as condoms and lubricant as well as instructions on how to use them properly. HIV efficacy trials enroll thousands of participants over several years, and with even with the best counseling some participants will still become infected through their risky behavior. Changing human behavior is never easy; after all, many people still smoke, even though it is widely known that smoking is the major cause of lung cancer. An AIDS epidemic would not exist if prevention was as simple as counseling people to change their risky behavior.

Myth No. 6: Now that there are pills that can prevent HIV infection, an HIV vaccine is no longer necessary.

HIV-negative people who are at high risk can take antiretroviral medication daily to try to lower their chances of becoming infected if they are exposed to the virus. This type of therapy – called PrEP, short for PreExposure Prophylaxis – has been shown to be effective among those at high risk. However, it has not yet been recommended for widespread use. PrEP is unlikely to be an option for everyone because the pills are expensive and are not always covered by insurance, may cause side effects, and not everyone has access to them. Remembering to take a pill every day is also challenging for some people. The most effective way to eliminate a disease is by using an effective vaccine. It was a vaccine that eliminated small pox and has almost eliminated polio. Most likely it will be an HIV vaccine that eliminates HIV from the world. Vaccines are an effective, affordable and practical option.

Myth No. 7: An HIV vaccine is unnecessary because AIDS is easily treated and controlled, just like diabetes.

While treatment for AIDS has dramatically improved over the last 30 years, it is no substitute for prevention. Current HIV medications are very expensive, and there are also many side effects. Sometimes people develop drug resistance and have to change the regimen of pills they take. Access to these drugs for the uninsured in the U.S. and those in the developing world is also very limited.

Myth No. 8: The search for an HIV vaccine has been going on for a long time and it’s just not possible to find one that works.

The science of HIV-vaccine development is challenging, but scientific understanding continues to improve all the time. In just the past two years there have been promising results from the RV144 study in Thailand as well as exciting laboratory work, such as the discovery of new broadly neutralizing antibodies against HIV. HIV is a powerful opponent, but scientists are constantly learning from one another and using advanced technology to fight it. Science has come a long way in the 30 years since AIDS was discovered. In comparing preventive HIV vaccine work to other vaccine development, the time it has taken is not so surprising; the polio vaccine took 47 years to develop.

Myth No. 9: Vaccines cause autism and just aren’t safe.

This is not true. Numerous studies in the past decade have found this claim to be false. The British doctor who originally published the finding about vaccines and autism has since been found to have falsified his data. There is actually no link between childhood vaccination and autism. It is true that vaccines often have side effects, but those are typically temporary (like a sore arm, low fever, muscle aches and pains) and go away after a day or two. The value of protection to vaccinated individuals and to the public has made vaccines one of the top public health measures in history, second only to having a clean water supply.

Myth No. 10: People who aren’t at risk don’t need an HIV vaccine.

A person currently may not be at risk for HIV, but life situations can change along with disease risk. Such a vaccine also may be important for one’s children or other family members and friends. By being knowledgeable about preventive HIV vaccine research, a person can be part of the solution by educating friends and family about the importance of such research and debunking the myths that surround it. Even if a person is not at risk, he or she can be part of the effort to find a vaccine that will hopefully save the lives of millions of people worldwide.

To learn more or find out how to get involved in an HIV vaccine study, please visit www.hvtn.org

WBBA President Chris Rivera said the upbeat report on state’s life sciences industry was “conservative” — but added there were challenges that threatened the sector’s growth, including burdensome regulation and increased competition from competitors both here in the U.S. and abroad.

The report “Trends in Washing’s Life Sciences Industry 2007–2011”, which was prepared for WBBA by the Washington Research Council, found that the life sciences was now the fifth largest employment sector in the state, after transportation and equipment manufacturing, agriculture, software, and food and beverage manufacturing.

The sector, which does not include hospitals and other health services, employs 33,519 individuals directly, whose employment, in turn, supports as many as 57,000 other jobs indirectly for a total of nearly 91,000 overall, the report said.

In general, life science jobs are well paid, with an annual average wage of $77,490, compared to the state’s average private sector wage of $48,519 a year.

Overall, the sector adds $10.4 billion to the state’s gross domestic product of $340.5 billion in 2010.

Chris Gregoire

In her address to the conference, Gov. Christine Gregoire said collaboration has been the key to the success of the state’s life science sector.

“Our growing life sciences sector is built on three strong pillars: our educational institutions, our private businesses, and our nonprofit organizations,” she said, which “unlike many around the world are all working together.”

Gregoire cited a number of promising programs designed to support the sector, in particular small start ups, but warned that cuts to education due to the budget crisis threatened the sector.

“We cannot afford to continue to compromise our education system in this state and yet expect that we be on the cutting edge of the knowledge economy,” she said.

Speaker Highlight: Eli Lilly CEO John Leichleiter

Eli Lilly CEO John Leichleiter told the conference that while the U.S. Life sciences and biopharmaceutical sector was the “envy of the world” the sector is “facing today nothing short of a innovation crisis.”

Leichleiter blamed the high cost of research and development, burdensome regulation at home, and increased competition abroad, particularly from China and India.

Leichleiter noted that it now takes $1.3 billion to develop a new drug. At the same time, due to expiration of patents for a large number of top-selling drugs, the industry faces the loss of $150 billion in annual revenue. This means there will be less to invest in “next generation of medicines,” Leichleiter said.

These and other pressures are forcing a “wave of defensive consolidation” among “arge cap pharmaceutical companies, resulting in a “dwindling number of entities capable of taking a discovery to a medicine.”

At the same time,  China and India are “producing more scientists and engineers than we are and are intensely focussesing on developing their innovation capacity,” Leichleiter said.

Leichleiter proposed five policy remedies:

1. Improve science and math literacty by improving K througn 12 education.
2. Immigration reform that “allows and encourages top scientists to choose to work in the U.S.”
3. Strong and sustained federal support for research: Medical research is a long process, he noted, “the funding must be consistent, predictable and sustained” in order to attract researchers and keep them engaged.
4. Tax reform: Lowering corporate tax rates to the 20 to 25 percent range, more in line with the rates seen in competitor nations.
5. Regulatory reform: Make drug approval quicker and more predictable and that better balances risks against potential benefits. “The pressure on regulators is to err on the side of avoiding risks, when some patients might accept those risks for the treatments potential benefit,” he said.

University of Washington President Michael Young echoed Gregoire’s and Leichleiter’sconcern about the effect state and federal budget cuts may have to the education system.

Young argued that there were three elements needed for a successful regional high-tech sector: an “innovative, imaginative business community that is willing to take risks”, a university that included “economic development in its mission,” and a supply of well-trained, “entrepreneurial students.”

That third leg was under threat due to budget cuts to public education, he warned.

WBBA also announced 2011 winners of their Innovation Award.

Seattle Genetics was recognized for its work on Adcetris (brentuximab vedotin), approved for the treatment of patients with relapsed Hodgkin lymphoma, and for the treatment of patients with relapsed systemic anaplastic large cell lymphoma.

Amgen was recognized for the FDA approval of Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fractures, as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

“Success in today’s economy is most directly tied to a region’s ability to grow, retain and attract human capital,” Young said.

Young argued that reason why the U.S. has been able to thrive as as the world economy have evolved from an economy based on first, agriculture, then industry, then services and now knowledge, was that it had an economic and regulatory environment that allowed businesses to adapt, a cutting-edge research infrastructure, and the “mechanisms for the best and the brightest to rise to the top,”

“The mechanisms that has allowed the best and the brightest to rise to the top have been the universities,” Young said, particularly the public universities, which educate the vast majority of America’s young.

To learn more:

• Read the Washington Research Council’s report: Trends in Washingotn’s Life Sciences Industry 2007 – 2011

Elias joined PATH in 2000, when the organization had a budget of $44 million and a staff of 297 employees. He led the organization through a period of significant growth, and the non-profit now has an annual budget of $295 million and more than 1,100 on staff working on project in more than 70 countries.

In his new position, Dr. Elias focus on developing integrated health-care delivery of interventions for the developing world. In addition, he will oversee the foundation’s Family Health and Vaccine Delivery strategies along with Global Development’s existing work in Agricultural Development, Financial Services for the Poor, Water, Sanitation & Hygiene, and Special Initiatives.

The foundation’s U.S. and Global Libraries Programs will also be combined in this broader portfolio, the foundation said.

“I am deeply honored to be joining the Gates Foundation,” Dr. Elias said in a statement. “I look forward to applying my experience in health and development to help advance the foundation’s ambitious mission.”

Dr. Elias received his M.D, from Creighton University in 1983, and received an MPH in 1990 from the University of Washington, where he was also a fellow in the Robert Wood Johnson Clinical Scholars Program.

The malaria parasite

A malaria vaccine developed by the pharmaceutical company GSK and Seattle’s PATH has been shown to halve the risk of severe malaria in African children.

Malaria strikes an estimated 225 million people worldwide each year, killing more than 780,000 — most of whom are African children.

Currently, there is no approved vaccine for the prevention of the  disease, which is caused by the parasite Plasmodium falciparum.

The new results, which have been published online in the New England Journal of Medicine, were announced today in Seattle at a Malaria Forum hosted by the Bill & Melinda Gates Foundation, which provided major funding for the trial.

The study, which was conducted in seven countries in sub-Saharan Africa, found that three doses of the vaccine, called RTS,S, reduced the risk of a child developing high fever and chills by 56 percent and of severe malaria by 47 percent.

In the study ,the researchers looked at malaria rates among the first 6,000 children, aged 5 to 17 months, in the 12 months after they had received the third dose of the three-dose vaccine regimen.

All together, a total of 15,460 children are enrolled in the study in two age groups–a younger group, 6 to 12 weeks-old and a slightly older group 5 to 17 months-old.

The trial is ongoing, and results of the vaccine’s efficacy in infants 6 to 12 weeks-old are expected by the end of 2012, but a interim analysis of all of the infants and children enrolled in the trial 6 weeks to 17 months finds that at an average of about one year the vaccine reduced the risk of of severe malaria by a third, 34.8 percent.

In a commentary that accompanied the article, Dr. Nicholas White, professor of Tropical Medicine at Mahidol University in Thailand, writes that if all goes well, the RTS,S vaccine should become available in just over 3 years. “It’s been a long time coming, but it is becoming increasingly clear that we really do have the first effective vaccine against a parasitic disease in humans.”

But, he adds, questions remain: how long, for example, will the vaccine remain protective, how much will the vaccine cost, and, will the recent drop in malaria deaths due to other interventions, such as the increased use of insecticide-treated bed nets, cause a loss of support for expensive anti-malaria initiatives.

“How,” he asks, “will the necessary funding be sustained in the face of a global economic downturn, along with a reduction in political pressure associated with declining mortality form malaria?”

HIV virons (green) budding from a white cell -- Photo: C. Goldsmith/CDC

One pill a day can more than halve the risk that an uninfected partner in a heterosexual relationship will contract HIV from an infected sexual partner, a University of Washington study has found.

Such couples are called “serodisordant” because blood tests, called serological tests, indicate that one is infected with the virus that causes AIDS, HIV, and the other is not.

The study’s findings are “clear evidence that this new HIV prevention strategy, called pre-exposure prophylaxis (or PrEP), substantially reduces HIV infection risk,” the researchers said in a statement announcing the results.

“This study demonstrates that antiretrovirals are a highly potent and fundamental cornerstone for HIV prevention and should become an integral part of global efforts for HIV prevention,” said said Dr. Connie Celum, a UW professor of global health and medicine and the principal investigator of the study, known as the Partners PrEP Study.

The study was conducted by the UW International Research Center and  funded by the Bill & Melinda Gates Foundation.

The study, which is continuing, involves 4,758 HIV serodiscordant couples, in which one partner has HIV and the other does not, from nine research sites in Kenya and Uganda.

In the study, partners who were not infected with HIV took a daily tablet containing an HIV medication – either the antiretroviral medication tenofovir, tenofovir in combination with another antiretroviral emtricitabine, or a placebo.

A review by the study’s research team and the study’s Data and Safety Monitoring Board (DSMB), an independent group of experts that monitored the study’s conduct and safety, concluded over the weekend that the evidence of the drugs’ protective effect was so strong that the study results should be made public early and the placebo arm of the study be discontinued.

The board also recommended that the study continue with those receiving tenofovir and tenofovir combined with emtricitabine remaining on those medications and those receiving placebo to start receiving the drugs.

The review found that a total of 78 HIV infections occurred in the study: 18 among those in the tenofovir group, 13 among the drug combination group, and 47 among those assigned placebo.

Statistically, this means those taking tenofovir had an average of 62 percent fewer HIV infections and those who took the drug combination had 73 percent fewer HIV infections than those who received placebo.

“This is an extremely exciting finding for the field of HIV prevention,” said Dr. Jared Baeten, co-chair of the study and a UW associate professor of global health and medicine. “Now, more than ever, the priority for HIV prevention research must be on how to deliver successful prevention strategies, like PrEP, to populations in greatest need.”

To learn more:

• Visit the UW International Research Center’s Partners PrEP Study webpage.