Early results From Clinical Trials Of 2009 H1N1 Influenza Vaccines In Healthy Adults

We are encouraged by reports that are now emerging from various clinical trials of 2009 H1N1 influenza vaccines, conducted by various vaccine manufacturers. We expect additional companies to announce their preliminary trial results shortly. The early data from these trials indicate that 2009 H1N1 influenza vaccines are well tolerated and induce a strong immune response in most healthy adults when administered in a single unadjuvanted 15-microgram dose. We congratulate the companies on these trials, which are an important part of the ongoing worldwide effort to develop vaccines to protect the public from 2009 H1N1 influenza.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, also is conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials are testing two different dosages (15 micrograms versus 30 micrograms) and evaluating the immune response to one and two doses of these vaccines. More than 2,800 people are participating in ongoing NIAID trials of these vaccines.

We are pleased to note that preliminary analyses of early data from the NIAID trials align with the recently announced findings and those to be announced imminently by other companies in that both vaccines studied induced what is likely to be a protective immune response in most adults following a single dose in the same amount (15 micrograms) used in seasonal flu vaccines. Specifically, in blood samples obtained 8 to 10 days after vaccination

Among healthy adults who received a single 15-microgram dose of the Sanofi Pasteur vaccine, a robust immune response was measured in 96 percent of adults aged 18 to 64 and in 56 percent of adults aged 65 and older.

Similarly, among healthy adults who received a single 15-microgram dose of the CSL Limited vaccine, a robust immune response was measured in 80 percent of adults aged 18 to 64 and in 60 percent of adults aged 65 and older.

Additional data from the NIAID trials are forthcoming. However, on the basis of these strong early data, our results are consonant with other reports that a single 15-microgram dose of unadjuvanted 2009 H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64. For adults aged 65 and older, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust, as is the case with seasonal influenza vaccines.

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New Strategy Proposed For Designing Antibody-based HIV Vaccine

Most vaccines that protect against viruses generate infection-fighting proteins called antibodies that either block infection or help eliminate the virus before it can cause disease. Attempts to create a vaccine that induces antibodies that prevent HIV infection or disease, however, have so far been unsuccessful. But several recent studies suggest promising new research directions for the development of an antibody-based HIV vaccine, according to John R. Mascola, M.D., deputy director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, and colleagues.

These studies demonstrate that, contrary to widespread belief, it is not uncommon for people infected with HIV to naturally make antibodies that can neutralize a variety of HIV strains. These antibodies do not protect people from the virus because they arise years after HIV infection is established. However, if a vaccine could prime the body to make these broadly neutralizing antibodies before exposure to HIV, they could potentially prevent infection or hold the virus at bay until an army of immune cells assembles to limit viral replication.

Based on these findings, Dr. Mascola and colleagues recommend a research strategy that uses naturally occurring, broadly neutralizing anti-HIV antibodies for the ultimate design of an antibody-based HIV vaccine.

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Consumer Reports Survey: Nearly Half of Adults Won't Get Flu Vaccine, Citing Poor Excuses Like 'I Don't Get Sick'

According to a new survey from Consumer Reports Health, just 52 percent of Americans plan to get the flu vaccine this year, despite its being the best option for prevention. The Consumer Reports Health survey uncovered a long list of poor excuses for not getting the vaccine, including 5 percent of people who say they would rather get sick than go to work.

The vaccine is available for free for many (65 percent of those who have already been vaccinated reported no out-of-pocket expense for the vaccine), and at nominal cost for others, and requires very little time, Consumers Reports says.

The survey was conducted in early October by the Consumer Reports National Research Center, right as the flu season was getting underway this fall. Flu season typically begins in late October and can run through early May. Some 67 percent say it was better to build your own natural immunities.

"There is no evidence that people who get flu shots have lower natural immunities or that people who don't get flu shots have higher immunities," says Dr. John Santa, M.D., director of the Consumer Reports Health Ratings Center. Those surveyed cited the following other reasons for not getting the vaccine: They do not get sick (45 percent), they have themselves or know someone who has gotten sick from the vaccine (41 percent), or they believe the vaccine is ineffective (26 percent).

Other consumers not planning to get a flu vaccination said that they were worried about side effects (35 percent), medication is now available to treat the flu (28 percent), they don't like getting shots (27 percent), or they don't like going to the doctor (23 percent). And some (5 percent) even say that they'd rather get sick than go to work. "Sounds like a lot of excuses and misconceptions to avoid a quick and inexpensive, if not free, shot," says Santa.

Influenza (the flu) is a contagious respiratory illness caused by influenza viruses that, in milder cases, can make people sick for several days, and at times can lead to death. Nearly all adults who responded to the Consumer Reports survey (83 percent) report that they have had the flu.

According to the Centers for Disease Control and Prevention, more than 200,000 people are hospitalized each year from flu complications and about 36,000 people die from flu. Older people, young children, and people with certain health conditions are at high risk for serious flu complications.

"Despite the prevalence and potential seriousness of the flu, we found that many adults are surprisingly misinformed about both the flu and flu vaccination," says Santa. "People need to know that getting a flu vaccination every year is the best way to prevent the flu. The vaccine will not make them sick or give them the flu. Without it, they and their families are at higher risk for getting the flu. If they get the flu they may transmit it to vulnerable people for whom the consequences may be serious."

Fewer than half of those surveyed (49 percent) by Consumer Reports knew that the government recommends that everyone over 6 months old get vaccinated against the flu.

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NEWSWEEK Cover: The Hunt for an Addiction Vaccine

Although the American Medical Association recognized addiction as a disease back in 1956, only now are we beginning to see treatments that target the underlying biochemistry of that disease, Newsweek reports in the March 3 cover, "The Hunt for an Addiction Vaccine" (on newsstands Monday February 25).

Health reporter Jeneen Interlandi reports that this emerging paradigm treats addiction as a
chronic, relapsing brain disorder to be managed with all the tools at medicine's disposal. The addict's brain is malfunctioning, as surely as the pancreas in someone with diabetes. In both cases, "lifestyle choices" may be contributing factors, but no one regards that as a reason to withhold insulin from a diabetic.

"We are making unprecedented advances in understanding the biology of addiction," says David Rosenblum, a public-health professor and addiction expert at Boston University. "And
that is finally starting to push the thinking from 'moral failing' to 'legitimate illness'."

Interlandi examines the science that is helping to understand how the addicted brain functions and the compounds being developed or tested by the National Institute on Drug Abuse (NIDA) that block the intoxicating effects of drugs, including vaccines that train the body's own immune system to bar them from the brain. To the extent that "willpower" is a meaningful concept
at all, the era of willpower-in-a-pill may be just over the horizon. "The future is clear," says Nora Volkow, the director of NIDA. "In 10 years we will be treating addiction as a disease, and that means with medicine."

Vaccines that would arm the immune system against addictive drugs and prevent them from making the user high are, potentially, the ultimate weapons against addiction, Interlandi explains. A cocaine vaccine is poised to enter its first large-scale clinical trial in humans this year, and vaccines against nicotine, heroin and methamphetamine are also in development.

Nabi Biopharmaceuticals, a small biotech company in Maryland, has engineered a nicotine vaccine that is in late-stage clinical trials. Earlier studies showed that it was twice as effective as a placebo in helping people quit smoking. The cocaine vaccine, developed by Thomas
Kosten of Baylor College of Medicine, could be on the market as early as 2010. It would have to be given three or four times a year, but presumably not for life, says Kosten. While the vaccine is being studied in people who are already addicted to cocaine, it could eventually be used on others.

"You could vaccinate high-risk teens until they matured to an age of better decision-making," Kosten says. He acknowledges the obvious civil-liberties issues this raises. "Lawyers certainly want to argue with us on the ethics of it," he says, "but parent groups and pediatricians have been receptive to the idea."

The revolution these new drugs promise will have a huge impact on the addiction-treatment industry (or, as it prefers to think of itself, the "recovery movement"), which runs the gamut from locked psychiatric wards in big-city hospitals to spalike mansions in the Malibu Hills of California. And the reaction there is guarded; the people who run them have seen panaceas come and go over the years, and the same addicts return with the same problems. They also, of course, have a large investment in their own programs, which typically rely on intensive therapy and counseling based on the 12-Step Model.

"We need four or five more years to see how [Vivitrol] does," says staff psychiatrist Garrett O'Conner at the Betty Ford Center, in Rancho Mirage, Calif., about the medication that prevents patients from drinking alcohol by obliterating its ability to intoxicate. "And we need to
be very cautious, because a failed treatment will set a person back." The Ford Center and the Hazelden Foundation, in Minnesota, use drugs sparingly, and mostly just in the first days or weeks of recovery, the "detox" phase.

"Hazelden will never turn its back on pharmaceutical solutions, but a pill all by itself is not the cure," says William Moyers, Hazelden's vice president of external affairs. "We're afraid that people are seeking a medical route that says treatment is the end, not the beginning."

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Stockpiling Influenza Vaccine in Hong Kong

In light of the importance of virus monitoring for pandemic influenza preparedness and response, Indonesia’s refusal to share samples of avian flu (H5N1) virus with the World Health Organization for most of 2007 is "distressing and potentially dangerous for global public health," say two leading global health experts in an essay in this week's PLoS Medicine.

Laurie Garrett (Senior Fellow for Global Health at the Council on Foreign Relations, New York) and David Fidler (Professor of Law and Director of the Center on American and Global Security at Indiana University) say that Indonesia repeatedly refused to share H5N1 samples unless significant changes were made to allow it greater access to vaccine derived from samples it shared with WHO.

Typically some 250-300 million influenza vaccine doses are made each year, based primarily on samples of flu viruses circulating in Asia, yet most of those vaccinated are residents of rich countries. Some developing countries, say the authors, have challenged this strategy by asking “What’s in it for us? We share virus samples, and pharmaceutical companies make vaccines from them that primarily benefit rich countries. Without better access to vaccine, why should we share virus samples?”

Garrett and Fidler offer a novel proposal to overcome the virus sharing impasse. They propose that annually updated supplies of more than 500 million doses of highly specific influenza vaccine, plus antiviral medicines, protective masks and gloves, and germicide washes be stockpiled in Hong Kong. They select Hong Kong, they say, because it has shown "absolute transparency regarding disease emergences going back several decades," it is a dynamic center of virus research and response, and it sits in the middle of the ecological zone that has spawned the bulk of all flu strains known to have emerged over the last three decades.

"We advocate that the strategic stockpile be fed continuously and its specificity updated based on circulating forms of viruses," say the authors. "These objectives would be accomplished through an Advance Market Commitment (AMC) mechanism in which the G-8 nations and Asian powerhouses China, India, Singapore, South Korea, and Japan set aside a fund to guarantee purchase of stockpiled products. The Asia-Pacific Economic Cooperation forum (APEC) should manage the AMC fund and the stockpiled materials in Hong Kong. APEC has proven to be one of the most dynamic and effective of the world’s regional organizations."

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Researchers Find Monkeys Able to Fend Off AIDS-like Symptoms With Enhanced HIV Vaccine

Researchers at the University of Pennsylvania School of Medicine have discovered that using an immune system gene to enhance a vaccine used to study HIV in macaque monkeys provides the animals with greater protection against simian HIV (SHIV) than an unmodified vaccine. This multi-year study found that the addition of a molecule called Interleukin-15 effectively boosts the effects of a vaccine derived from the DNA of simian HIV. The study illustrates that DNA vaccine effectiveness can be improved by the inclusion of specific immune adjuvants, or helpers.

The findings are published in last week’s online edition of the Proceedings of the National Academy of Sciences.

“DNA vaccine technology has great promise for the development of vaccines and immune therapeutics for a variety of infectious diseases and cancers,” says senior author David Weiner, professor of Pathology and Laboratory Medicine at Penn. While previous studies have established that the technology can induce immune responses safely, “improving the immune potency of this platform is critical for further development in humans.”

The research builds on previous work aimed at engineering a more potent immune response to SHIV DNA vaccine technology. Mouse model studies previously showed that the cytokine IL-15 -- a substance that can improve the body's natural response to infection and disease -- helps better immune responses and protection, while this study mirrors those findings in a larger, non-human primate species.

In this study, the group of macaques that was injected with the vaccine containing a loop of DNA enabling them to make IL-15 developed no signs of AIDS-like symptoms when exposed to live SHIV, compared to four animals in the control group that received only the DNA vaccine. The modified vaccine appeared to help suppress viral replication among the IL-15 group.

Next, Weiner’s team will study the protected macaques to determine the actual mechanism of their protection, and seek out any pockets of the virus that may be hiding in specific immune compartments. The approach will also be tested for safety and immunogenicity in humans through the HIV Vaccine Trials Network.

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U.S. Spends More Than $100 Million on Advanced Development of H5N1 Influenza Vaccines

U.S. Health and Human Services Secretary Mike Leavitt announced today that the department has awarded contracts totaling$132.5 million to three vaccine makers for the advanced development of H5N1 influenza, or bird flu, vaccines using an immune system booster called an adjuvant.

Anadjuvant is a substance that may be added to a vaccine to increase the body's immune response to the vaccine's active ingredient, called antigen.

"In the event of an influenza pandemic, a vaccine that uses adjuvant could provide a way to extend a limited vaccine supply to more people," Leavitt says. "These contracts are a continuation of our aggressive multi-pronged approach to a potentially critical public health challenge."

The department awarded five-year contracts to GlaxoSmithKline for $63.3 million and to Novartis Vaccines and Diagnostics, Inc. for $54.8million. In addition, the U.S. is funding IOMAI Corporation for $14.4 million for 15 months to complete Phase 1 clinical trials of its candidate vaccine. IOMAI may receive an additional $114 million in funding uponsuccessful completion of the Phase 1 trials. Phase 1 trials are the firststage of testing in people and normally include a small (usually less than 100) group of healthy volunteers. Overall the three contracts support advanced development work through Phase 3 clinical trials in the U.S. that are aimed at obtaining U.S. licensure for the product. In addition, the contracts support the establishment of U.S.-based manufacturing capabilities.

Under the contracts each company will build up its capacity to produce within six months after the onset of an influenza pandemic either 150 million doses of an adjuvant-based pandemic influenza vaccine or enough adjuvant for 150 million doses of a pandemic influenza vaccine. In addition to supporting the development of each company's antigen-sparing vaccine candidate, the contracts also require each company to provide itsproprietary adjuvant for U.S. government-sponsored, independent evaluationwith influenza vaccines from other manufacturers.

Initial clinical studies of H5N1 vaccine in humans have shown that two 90- microgram doses of the vaccine are required to stimulate a level ofimmune response that researchers anticipate would provide protection for anindividual against the H5N1 strains that have been spreading among birds inAsia. However, the addition of adjuvant to these candidate vaccines mayreduce the amount of antigen (active ingredient) per dose needed to achieveeffective individual protection.

HHS' effort to pursue adjuvant-based vaccine is part of a broader effort by the department to accelerate the development and production of new technologies for influenza vaccines within the U.S. For example, in May 2006 HHS announced a $1 billion investment to support the advanced development of cell-based production technologies for influenza vaccinesand will help to modernize and strengthen U.S. influenza vaccine production by creating an alternative to producing influenza vaccines ineggs.

The H5N1 strain of avian flu has spread to more than 40 countries and has led to the deaths of hundreds of millions of additional birds, which has heightened concern about the possibility of a human flu pandemic. Furthermore, the number of avian flu cases in humans has reached more than 260 cases in 10 countries. More than half of those persons infected have died. To date, H5N1 avian influenza has remained primarily an animal disease, but should the virus acquire the ability for sustained transmission among humans, the potential for an influenza pandemic would have grave consequences for global public health.


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