Researchers at and associated with the International AIDS Vaccine Initiative (IAVI), at The Scripps Research Institute, and at the biotechnology companies Theraclone Sciences and Monogram Biosciences have discovered two powerful new antibodies to HIV that reveal what may be an Achilles heel on the virus. They published their work in Science this week.

Researchers will now try to exploit the newfound vulnerability on the virus to craft novel approaches to designing an AIDS vaccine. Moreover, the global collaboration and process that led to the discovery of the two new broadly neutralizing antibodies (bNAbs) are likely to produce more such antibodies, which may in turn reveal additional vulnerabilities of HIV, adding still more vitality to the effort to develop a vaccine against AIDS.

“The findings themselves are an exciting advance toward the goal of an effective AIDS vaccine because now we’ve got a new, potentially better target on HIV to focus our efforts for vaccine design,” said Wayne Koff, senior vice president of research and development at IAVI. “And having identified this one, we’re set up to find more, which should further accelerate global efforts in AIDS vaccine development.”

Broadly neutralizing antibodies to HIV are produced by a minority of HIV-infected individuals and are distinct from other antibodies to HIV in that they neutralize a high percentage of the many types of HIV in circulation worldwide. It is widely believed that to prevent HIV infection an AIDS vaccine would need to teach the body to produce these powerful antibodies before exposure to the virus. Animal experiments suggest that conceptually such a vaccine would work. Before this finding only four antibodies to HIV had been discovered that were widely agreed to be broadly neutralizing.

The two newly discovered bNAbs, called PG9 and PG16, are the first to have been identified in more than a decade and are the first to have been isolated from donors in developing countries, where the majority of new HIV infections occur. Moreover, previously identified bNAbs against HIV have functioned by binding to places on HIV that have proven difficult to exploit by means of vaccine design.

“These new antibodies, which are more potent than other antibodies described to date while maintaining great breadth, attach to a novel, and potentially more accessible site on HIV to facilitate vaccine design,” said Dennis Burton, professor of immunology and microbial science and scientific director of the IAVI Neutralizing Antibody Center at The Scripps Research Institute in La Jolla, California. Professor Burton is also a member of the newly established Ragon Institute of MGH, MIT and Harvard. “So now we may have a better chance of designing a vaccine that will elicit such broadly neutralizing antibodies, which we think are key to successful vaccine development.”

Breadth of neutralization is important because any effective AIDS vaccine must provide protection from a diverse range of the most prevalent types of HIV circulating worldwide. High potency suggests that such antibodies will not have to be produced by the body in very large quantities to confer protection.

The two new antibodies target a region of the viral spike used by HIV to infect cells. The viral spike glycoproteins, termed gp120 and gp41, are highly variable and have evolved to thwart immune attack. But biochemical studies suggest that PG9 and PG16 target regions of gp120 that do not change, which probably accounts for their breadth of neutralization. Now researchers at the IAVI-organized Neutralizing Antibody Consortium (NAC), a scientific network focused on designing vaccines capable of eliciting broadly neutralizing antibodies, will turn their attention to studying the molecular structure of PG9 and PG16 and that of the region they target on the HIV spike. They will use this information to try to devise immunogens - the active ingredients of vaccines - that elicit similar antibodies.

How they were discovered

The methods by which PG9 and PG16 were isolated are themselves proving instructive. Their identification represents the first success of an ongoing global hunt launched by IAVI in 2006 to find new bNAbs to support the rational design of novel AIDS vaccine candidates. The effort, named Protocol G, is unprecedented in scale and distinguished by its emphasis on identifying antibodies that neutralize subtypes of HIV circulating primarily in developing countries. IAVI’s clinical research partners have collected blood specimens from upward of 1,800 HIV-infected volunteers from IAVI-supported clinical research centers in seven sub-Saharan countries as well as from centers in Thailand, Australia, the United Kingdom and the United States.

All samples were sent to Monogram Biosciences, which, working with researchers at IAVI’s AIDS Vaccine Design and Development Laboratory in New York City and the IAVI Neutralizing Antibody Center at The Scripps Research Institute, screened the sera for broadly neutralizing activity. Researchers historically have sought bNAbs in serum by testing whether antibodies from such samples bind to soluble versions of gp120 and gp41. It turns out that PG9 and PG16, however, bind to soluble forms of the proteins very weakly, if at all. The antibodies were detected only because a micro-neutralization assay developed by Monogram in partnership with IAVI measuring their ability to block HIV infection of target cells was run in parallel with the standard binding assays used for screening. This has significant implications for the future screening of bNAbs.

“If you think of it as a fishing expedition,” said Christos Petropoulos, chief scientific officer and vice president of virology research and development at Monogram Biosciences, “we and the rest of the field were previously using the wrong bait in the search for HIV-specific broadly neutralizing antibodies. Together with colleagues at IAVI, we reasoned that the best approach to identifying antibodies with the most potent and broad neutralizing activity was to screen directly for their ability to block HIV infection. To do this we developed a new, specialized test known as the micro-neutralization assay, which has opened up new avenues for exploration of additional donors for similar antibodies.”

Once the researchers had ranked the top 10% of serum samples in terms of breadth of neutralization, they needed to isolate the actual bNAbs. This can be painstaking work. But Theraclone Sciences, a company that had been working outside the HIV field, had a relevant and unique high-throughput process that it adapted to HIV work with financing from IAVI’s Innovation Fund, which is co-funded by the Bill & Melinda Gates Foundation. The Theraclone team used a system designed to expose the entire repertoire of antibodies from a blood sample obtained from an HIV-infected individual. Antibodies with broadly neutralizing potential were identified from this pool and traced to their corresponding antibody-forming cells. Using recombinant DNA technology, bNAb genes were then isolated from these cells to enable the production of unlimited quantities of the antibody clones for research.

“It is exciting that we were able to use our technology to identify and isolate these new bNAbs, which may offer important clues that could help create an effective AIDS vaccine. Through this strong scientific partnership, we have rapidly delivered promising results,” said Matthew Moyle, chief scientific officer and senior vice president of Theraclone Sciences. “This project has been a useful demonstration of Theraclone’s antibody discovery platform in infectious disease, and we highly value IAVI’s collaborative approach to solving the AIDS vaccine challenge,” said David Fanning, president and CEO of Theraclone Sciences.

With a large pool of HIV-positive donors from Protocol G now identified whose serum contains HIV-specific broadly neutralizing antibodies, it is likely that this global collaboration will generate more bNAbs that will benefit the vital enterprise of accelerating AIDS vaccine development.

“The story of the discovery of these two new antibodies demonstrates the challenges of AIDS vaccine research but also the power of the collaboration that formed to produce this advance. This is what can happen when you have researchers from the global North and South, from academia and industry, from within and outside the HIV field, working together in a framework to speed innovation,” said Seth Berkley, president and CEO of IAVI. “By working in this manner, I am confident we will continue to move toward solving the AIDS vaccine challenge, one of the greatest scientific and public health challenges of our time.”

The published study on the two new bNAbs is available online at http://www.sciencemag.org.

Source:
Keith McKeown

Scripps Research Institute

The National Institutes of Health (NIH) has awarded a consortium of Chicago-based institutions, led by Rush University Medical Center, a five-year, $3.75-million grant to establish a Developmental Center for AIDS Research, creating a comprehensive research infrastructure to spur basic science, clinical studies and translational research in the prevention, detection and treatment of HIV infection and AIDS.

The new center is one of only two in the Midwest - the other is in Cleveland, Ohio - and was the only developmental center funded this year. NIH has funded 20 such centers at major academic institutions across the country.

The center in Chicago involves investigators from Rush, the University of Illinois at Chicago (UIC) and Cook County Health and Hospitals System, who will collaborate across disciplines and institutions to advance HIV/AIDS research. Chicago ranks sixth among U.S. cities in the number of HIV cases, with approximately 21,000 known infections and another 5,000 presumed infections.

“With this grant, we have an unparalleled opportunity to make Chicago an epicenter for AIDS research, focusing on translational research that takes investigations from bench to bedside, and out to the community, to make a truly significant impact,” said Alan Landay, PhD, chairman of immunology and microbiology at Rush, director of the new center, and an internationally recognized expert in immunology and HIV pathogenesis.

The NIH funding will be used to create shared “core” facilities that provide expertise and services to participating laboratories at all three institutions.

Rush will head the administrative and developmental cores, with responsibility for strategic planning and operational management. It will oversee scientific communications and funding for important new areas of research and launch a special outreach effort to share advances with the affected community in Chicago.

The University of Illinois at Chicago will direct the basic science and the social and behavioral sciences cores. The basic science core will provide access to, and training in, state-of-the-art technologies for laboratory investigations in virology, molecular biology, immunology and other areas. The social and behavioral sciences core will support research involving social, behavioral and psychosocial issues and facilitate studies and interventions in local, national and international communities.

“Numerous scientists and community activists in our three institutions have been working largely independently to reduce the scourge of HIV/AIDS. This research initiative will provide opportunities for us to share and build upon our varied expertise and perspectives. I fully expect new prevention and treatment strategies to arise from this exciting collaboration,” said Robert Bailey, PhD, professor of epidemiology at the UIC School of Public Health and co-director of the new AIDS research center.

Cook County Health and Hospitals System will direct the clinical core, assisting investigators with clinical and epidemiologic research and facilitating translation of basic science discoveries into the patient care realm. The Ruth M. Rothstein CORE Center for the Prevention, Care and Research of Infectious Diseases, a partnership between Rush and Cook County, sees more than 5,000 HIV-infected individuals each year from diverse communities and has extensive expertise in HIV clinical care and clinical research.

“By including Cook County Health and Hospitals System, the outstanding research team brought together by this grant will be able to address issues that increase HIV-associated morbidity and mortality among the disadvantaged minority populations we serve. That is an extremely important mission for the new center,” said Dr. Audrey French, director of the clinical core and director of research at Cook County’s CORE Center.

The Developmental Center for AIDS Research in Chicago will concentrate its investigations around three themes: HIV and women, with an emphasis on behavior and viral pathogenesis; HIV and aging, including studies of behavioral, cardiovascular, immune system and neurocognitive issues; and HIV and drug abuse, focusing on behavioral questions and neuropharmacology.

Source:
Sharon Butler

Rush University Medical Center

The following summarizes selected women’s health-related blog entries.

• “National and State ACLU File Suit To End Ab-Only Funding in Mississippi,” Jodi Jacobson, RH Reality Check: The American Civil Liberties Union on Monday “asked a federal court in Mississippi to end government funding of religion in the state’s abstinence-only-until-marriage program,” Jacobson writes. According to the lawsuit, religious themes were used in the state Department of Human Services’ annual teen abstinence summit in 2008 and 2009. Kristy Bennett, staff attorney with ACLU of Mississippi, noted that studies have shown that abstinence-only sex education programs are ineffective at preventing teen pregnancy or the spread of sexually transmitted infections. Bennett also said, “‘Given the high rates of teen pregnancy and HIV infection in Mississippi, the failings of this year’s summit are inexcusable.’” According to Jacobson, Congress since 1996 has appropriated more than $1.5 billion “for programs that focus solely on promoting abstinence and censoring information that young people need to make healthy and responsible decisions about sexuality.” She concludes that “studies show that curricula that stress waiting to have sex while providing information about effective contraceptive use can significantly delay the initiation of sex, reduce the frequency of sex and the number of sexual partners and increase condom or contraceptive use among sexually active teens” (Jacobson, RH Reality Check, 9/9).
  
• “Religious Progressives Raise Concerns About Abortion in Health Care Reform,” Dan Gilgoff, U.S. News & World Report’s “God & Country”: Left-leaning religious advocates who support health care reform are pressuring Democrats to revise Rep. Lois Capps’ (D-Calif.) amendment on abortion coverage under the House health reform bill (HR 3200). One idea the advocates are floating is to create a second public health insurance plan that excludes abortion coverage, Gilgoff reports. Another suggestion is to offer abortion coverage as a supplemental insurance rider. Chris Korzen, executive director of Catholics United, said that the Capps amendment “‘addresses the vast majority of concerns [of] the moderate pro-life community’” with regard to provider “conscience” protections and abortion coverage. However, the “‘question of how to handle abortion coverage in the public option has proven more difficult to answer,’” Korzen said. According to Gilgoff, progressive religious groups are concerned “that without revising abortion provisions in the public option, the debate over abortion can bring down the whole health care reform effort.” He adds, “Progressive faith groups have been an important part of the Democratic coalition pushing for health care reform, making a moral case for the effort in the face of opposition from conservative religious activities and lending organizing muscle” (Gilgoff, “God & Country,” U.S. News & World Report, 9/9).
  
• “Reproductive Health in the Baucus Plan,” Dana Goldstein, American Prospect’s “Tapped”: Goldstein asks, “After health reform, who will decide what medical services insurance companies must cover ” The House bill (HR 3200) and Senate Health, Education, Labor and Pensions Committee’s bill would establish a committee of experts to make recommendations to the HHS secretary. Senate Finance Committee Chair Max Baucus’ (D-Mont.) plan “articulates broad areas of coverage that must be included, such as preventive care, primary care, hospital stays and maternity care,” Goldstien says. However, she writes, “Baucus would allow insurance companies themselves to define what services each of those areas include, without government interference.” Reproductive health advocates are “cautiously optimistic” about Baucus’ proposal, Goldstein reports. Adam Sonfield of the Guttmacher Institute said, “‘Services like contraception, [sexually transmitted infection] testing and treatment, and Pap tests can and certainly would fit into many of the other categories,’” such as preventive care. Abortion coverage “would likely remain unchanged” under Baucus’ plan because there is no public option, and most insurance companies already choose to cover the procedure, Goldstein writes (Goldstein, “Tapped,” American Prospect, 9/10).
  
• “Obama Isn’t Budging on Abortion in Health Care Reform” Dan Gilgoff, U.S. News & World Report’s “God & Country”: “President Obama devoted a single line of his speech” Wednesday to the growing debate about abortion coverage under health reform legislation, Gilgoff writes. The president’s assurance that federal dollars will not fund abortion “sounds like an endorsement of the House health care bill’s approach to abortion coverage,” according to Gilgoff. He adds, “It’s worth noting that Obama didn’t acknowledge the growing concern of religious progressives about Americans in the public health insurance plan being forced to fund abortions with their premiums. On abortion — and for the moment — the White House isn’t budging at all” (Gilgoff, “God & Country,” U.S. News & World Report, 9/10).
  
• “Sexism, Collusion and the Price of Eggs,” Kerry Howley, Double X’s “XX Factor”: A recent Double X article on state laws prohibiting compensation for egg donors “woke me up” and “got me thinking about the issue,” Howley writes. The “pieces spoke of blanket bans on cash for ova in scientific research,” Howley writes, adding, “By contrast, compensation for ova used by prospective mothers is generally seen as a carnivalesque open market free-for-all.” She continues that industry and reproductive groups cap such compensation “under the assumption that ova donors … should be motivated by nurturing, womanly, fuzzy fellow-feeling,” even though “no one expects a man to give up his sperm out of some heartwarming love of humanity.” Infertility clinics “are rarely challenged, and very often applauded, by left-wing consumer advocates and right-wing social conservatives trying to shield women from the true price of their ova,” Howley adds (Howley, “XX Factor,” Double X, 9/10).
  
• “Increasing Access to Abortion Through Advanced Practice Clinicians: An Advocacy Agenda,” Tracy Weitz, RH Reality Check: Weitz posts an article she recently published in the journal Contraception that examines the declining availability of abortion services and promotes a strategy to “ameliorate this problem” by increasing the number of physician assistants, nurse practitioners and certified nurse midwives. The article said it is “time to acknowledge” that such health care professionals “are capable and qualified to provide abortion care services, but the current efforts to provide this care are thwarted by both the politics of health care and the politics of abortion.” The article calls for advanced practice clinicians, reproductive health advocates, physicians and attorneys to “join together to promote the provision of abortion by APCs, thereby protecting both women’s access to abortion care and practitioners’ rights to provide essential care for their patients” (Weitz, RH Reality Check, 9/10).
  
• “Throwing Women Overboard — Again,” Martha Burk, Huffington Post blogs: In a “short — but not too sweet — message to the president,” Burk chides President Obama for appeasing Republicans by stating in Wednesday’s speech that no public funds would be used to cover abortion under his health reform plan. Burk reminds Obama, “Women put you in office, and stuck with you when the crazies were beating you up with ‘death panel’ and ’socialized medicine.’” She continues, “We still support you but like millions of women who were watching, we wonder why you have to always use our most intimate health issues as a bargaining chip to give away, when you’re not going to get anything back.” According to Burk, “You let us down once again by not calling for repeal of the restrictions on our reproductive health care that are already in place in House Appropriations Committee Chair David Obey (D-Wis.). “[W]e must work hard right now to preserve President Obama’s (and now Dave Obey’s) evidence-based pregnancy prevention funding through the full Senate vote and continue the alliance with … Obey to maintain the initiative through the conference committee reconciliation,” Newman writes. Newman then lists five lessons for advocates to learn about Obey and concludes, “We must work with Dave Obey now because when it comes to sex education, our opponents will stop at nothing” (Newman, Huffington Post blogs, 9/10).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Male circumcision among heterosexual men in low male circumcision, high
HIV prevalence settings is beneficial and cost effective, says a new
article
in the open access journal PLoS Medicine. Male circumcision should be
considered as part of a combination HIV prevention package and not as an
isolated measure. One HIV infection can be averted for every five to 15
male circumcisions performed, and the costs to avert one HIV infection
ranging
from US$150 to $900 using a 10-y time horizon, say the authors. The report
is based upon a series of meetings of experts convened by UNAIDS, the
World
Health Organization (WHO), and the South African Centre for
Epidemiological Modelling and Analysis (SACEMA) that reviewed the outcomes
of six
simulation models on key policy and programmatic decision-making questions
related to male circumcision.

The models predicted that both premature postoperative resumption of
sexual intercourse and behavioural risk compensation, if confined to newly
or
already circumcised men and their partners, have only small population
level effects on the anticipated impact of male circumcision service
scale-up
on HIV incidence. Women benefit indirectly from reduced HIV prevalence in
circumcised male partners and male circumcision service scale-up acts
synergistically with other strategies to reduce HIV disease burden, says
the group. Male circumcision has minimal impact on reducing HIV
transmission
among men who have sex with men.

The group, called UNAIDS/WHO/SACEMA Expert Group on Modelling the Impact
and Cost of Male Circumcision for HIV Prevention, was led by Dr. Catherine
Hankins, Chief Scientific Advisor at UNAIDS.

Funding:
The three UNAIDS/WHO/SACEMA modelling meetings were funded
through the First UN Work Plan on Male Circumcision and HIV, which was
supported
by the Bill & Melinda Gates Foundation, the United States National
Institutes of Health, the French Agence nationale de recherches sur le
sida, and
the Joint United Nations Programme on HIV/AIDS. The funders had no role in
study design, data collection and analysis, decision to publish, or
preparation of the manuscript.

Citation:
“Male Circumcision for HIV Prevention in High HIV Prevalence Settings: What Can Mathematical Modelling Contribute to Informed Decision Making?”
UNAIDS/WHO/SACEMA Expert Group on Modelling the Impact and Cost of Male Circumcision for HIV Prevention (2009)
PLoS Med 6(9): e1000109. doi:10.1371/journal.pmed.1000109

Source
PLoS Medicine

Medical providers on the front lines of HIV care applaud the U.S. Congress for extending the Ryan White HIV/AIDS Program, helping to ensure that more than half a million low-income, uninsured, or underinsured people living with HIV/AIDS have access to lifesaving care. The HIV Medicine Association (HIVMA) and the Ryan White Medical Providers Coalition (RWMPC) are pleased with Congress’ four-year extension of this critical safety net and urge President Obama to quickly sign this important legislation.

“As HIV clinicians and researchers, many of whom have been providing HIV care since the mid-1980s, it is gratifying to see so many of our patients benefiting from the current treatment approaches, especially compared with the heartbreaking patient outcomes we saw earlier in the pandemic,” said Michael S. Saag, MD, FIDSA, HIVMA chair-elect. “These remarkable outcomes simply would not be possible without support from the Ryan White Program. We thank Congress for extending this vital program for four years, and we call on the president to quickly sign this legislation to ensure that our patients have access to the care they need.”

The Ryan White HIV/AIDS Treatment Extension Act of 2009 would authorize a 5 percent annual increase in funding for the program, which funds medical care and other services for individuals who otherwise would likely go without care. With more than 50,000 new cases of HIV infection in this country every year, HIVMA and RWMPC urge lawmakers to increase Ryan White funding annually by at least this authorized amount, if not more, during the next four years to help address the growing need for treatment.

“Even before the current recession hit, many HIV clinics and providers were struggling to maintain the level of services that have made them so effective at delivering lifesaving care to their patients,” said Kathleen Clanon, MD, RWMPC co-chair. “As the strains on our health care system grow, HIV caseloads rise, and state HIV programs are threatened by additional budget cuts, adequate funding increases for the Ryan White Program will be critical to ensuring that patients continue to receive the multidisciplinary care they need, even when they cannot afford it.”

With lawmakers finalizing health care reform legislation, the extension of the Ryan White Program is vital to ensuring there are no gaps in coverage or access to care for those living with HIV/AIDS as reforms are implemented nationwide. Additionally, health reform offers a unique opportunity to increase support for the medical home model of care provided by Ryan White programs and to integrate these programs into the reformed health care system.

“Ryan White programs, at HIV clinics around the country, are models for delivering high-quality, cost-effective care to people with chronic conditions,” said J. Kevin Carmichael, MD, RWMPC co-chair. “This patient-centered approach, known as the medical home model, treats the whole person by providing a range of services that HIV/AIDS patients need to stay healthy. It’s critical to keeping people with HIV in treatment and addressing their complex health care needs.”

Treatment advances have transformed HIV infection from a death sentence to a chronic condition for many patients, but only for those with ongoing access to medical care. “Funding through Ryan White has allowed HIV clinics across the country to develop model programs to deliver this comprehensive and coordinated care for more than a decade,” said Dr. Saag. “We could not do the work we do every day without this support, and this four-year extension will help ensure that it continues.”

Source:
John Heys

Infectious Diseases Society of America

Researchers in New York City are reporting their work uncovering a new epidemic of hepatitis C virus (HCV) infection among men-who-have-sex-with-men (MSM) who have HIV infection. These authors have previously reported unusually rapid fibrosis progression due to new HCV in MSM who have HIV infection and now expand on their findings, demonstrating that sexual transmission rather than injection drug use is the route of infection. Treatment is highly successful if started early in the course of infection, however, they report ominous news about liver disease progression. “This epidemic represents a new clinical syndrome for HCV infection that turns much of our knowledge on its ear: a new risk group becoming infected through a previously rare route of transmission resulting in unprecedented progression of liver fibrosis,” said Daniel Fierer, MD, principal investigator on this study.

In an analysis of 21 HCV-infected patients matched with uninfected controls, unprotected receptive anal and oral sex were significantly associated with new HCV infection. Neither current nor prior injection drug use was associated with HCV infection. In addition, treatment with pegylated interferon and ribavirin, initiated within 6 months of diagnosis, was completed in 16 patients with genotype 1 HCV infection; 12 (75%) achieved sustained viral response (SVR), compared to the 15-30% SVR rate expected with chronic genotype 1 HCV infection. Of significant concern, however, 30 patients underwent liver biopsy during the early infection period and 23 (77%) already had moderate fibrosis, making early curative treatment even more important to prevent further progression of liver fibrosis.

Because of these findings, study authors recommend routine screening for acute HCV for all MSM patients with HIV, using a simple and inexpensive algorithm of ALT measurement every 3 months and HCV antibody measurement every 6 to 12 months. “Changing the perception and behavior of physicians and patients is difficult,” said Dr. Fierer, “One of the main barriers to early detection is the lack of recognition by physicians and patients alike that HIV-infected MSM are at risk for HCV infection. This lack of perception of the problem results in lack of screening of HIV-infected MSM and therefore lack of timely diagnosis and treatment.”

Dr. Fierer thinks the next steps in battling this epidemic are educating HIV providers about the existence of this world-wide epidemic, educating patients at risk that unprotected sex among HIV-infected men is a significant risk for HCV infection, and changing the official recommendations by the US national authorities such as the CDC, HIVMA, etc, as has already been done in Europe and more recently at the state level in New York.

Abstract title:

Characterization of an epidemic of sexually-transmitted acute hepatitis C infection in HIV-infected men in New York City

About the AASLD

AASLD is the leading medical society focused solely on advancing the science and practice of hepatology and represents more than 3,300 practitioners, researchers, and allied health professionals worldwide. Founded by physicians in 1950, AASLD has upheld the standards of the profession and fostered research that generates treatment options for the millions of patients with liver diseases.

Source: American Association for the Study of Liver Diseases

A U.S.-backed vaccine experiment in Thailand has for the first time demonstrated a “small but measurable” benefit in preventing HIV infection, the Washington Post reports (Brown, Washington Post, 9/24). Col. Jerome Kim, a physician involved with the trial who is manager of the army’s HIV vaccine program, said that although the reduction in transmission was small, it is statistically significant and means the vaccine was 31.2% effective (McNeil, New York Times, 9/25). According to the Post, the “chief usefulness” of the vaccine is “likely to be what it can teach virologists about what is happening in the immune system when a person is even somewhat protected from HIV.” The vaccine is not expected to be licensed or produced in large amounts, and it is unlikely that countries would consider it effective enough to be used as a public health measure to reduce the spread of HIV. Nonetheless, the findings are considered a milestone, as they mark the first positive results of an HIV vaccine after two decades of experiments (Washington Post, 9/24).

The vaccine combines Sanofi-Pasteur’s ALVAC canary pox vaccine and AIDSVAX, a failed HIV vaccine made by VaxGen, which is owned by the not-for-profit Global Solutions for Infectious Diseases (Fox, Reuters, 9/24). The six-year study involved 16,000 Thai men and women and was run by the U.S. Army, NIH and Thailand’s Ministry of Public Health. According to the Post, about 40% of the participants were women, and many were employed in shipping and manufacturing enterprises along the Thai coast. A few were injection drug users and men who have sex with men — two groups considered at high risk for HIV transmission. Researchers randomly assigned participants to receive the vaccine or a placebo. Participants were counseled on methods of HIV prevention and advised to use condoms (Washington Post, 9/24).

The participants received six immunizations over six months, two with AIDSVAX and four with ALVAC (Reuters, 9/24). Fifty-one of the 8,197 vaccinated people became infected with HIV in the three years after the shots, compared with 74 of the 8,198 people who received placebos (Washington Post, 9/24). Further details of the study, which cost $105 million, will be presented at a vaccine conference in Paris in October (Marchione, AP/San Francisco Chronicle, 9/24).

Researchers said the vaccine, known as RV 144, “protected too few people to be declared an unqualified success,” and they were also “puzzled” by the trial’s results because the vaccine did not change the amount of HIV in a person’s blood compared with someone who received a placebo, the New York Times reports. A vaccine that offers partial protection typically lowers the viral load. However, this did not occur in the trial, which suggests that the vaccine does not produce neutralizing antibodies — which attack virus cells — like most vaccines, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which paid for most of the trial. He said the vaccine may produce “binding antibodies,” which attach themselves to and empower effector cells, a type of white blood cell attacking the virus (McNeil, New York Times, 9/25).

Fauci said, “Conceptually, we know a vaccine is possible,” adding, “Whether the vaccine is going to look anything like this one, I don’t know. But at least we know it can be done” (Washington Post, 9/24). Mitchell Warren, executive director of AVAC, the AIDS Vaccine Advocacy Coalition, said that the results of the study are “hugely exciting and, frankly, unexpected,” adding that although RV 144 “is not the vaccine that ends the epidemic,” it is “a fabulous new step that takes us in a new direction” (New York Times, 9/25).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.