Increasing Number Of Youth In Czech Republic Not Practicing Safer Sex To Prevent HIV Transmission

Increasing numbers of young people in the Czech Republic are not protecting themselves against HIV transmission, according to the Czech daily newspaper Mlada Fronta, the Prague Daily Monitor reports. According to the Daily Monitor, a recent survey among 139 young people ages 16 to 19 in the country found that most do not take precautions during sex to avoid contracting HIV or other sexually transmitted infections. Two-thirds of respondents said that they fear HIV/AIDS but do not believe they can acquire the virus, according to the Daily Monitor. In addition, 39% of survey participants said they insist on using condoms during sex. “The disease is no longer widely discussed and, in addition, Czech young people believe that it [is] curable,” Dalibor Sedlacek of an HIV/AIDS center in Plzen, Czech Republic, said. According to the Daily Monitor, the country has recorded 920 HIV cases, although some doctors say the number of HIV-positive people in the country could be five times as high (Prague Daily Monitor, 2/5).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Human Trial Results Show Excellent Safety Data, From Geovax’s DNA/MVA AIDS Vaccines

GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax’s AIDS vaccine. Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease (“AIDS”) caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.

Early results from GeoVax’s preventative HIV/AIDS vaccine human trials:

* Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006

* indicate that as low as 1/10th of a full dose of GeoVax’s HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients

* Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006

* Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007

* Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated

The 1/10th dose trial, begun April, 2006, is evaluating GeoVax’s AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.

“We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine,” said Dr. Harriet Robinson, GeoVax’s Chief Scientific Advisor and developer of the AIDS vaccine. “This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax’s DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax’s MVA vaccine at week 16 and again at week 24.”

The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.

Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non-human primates for more than 3 ВЅ years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax’s vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.

More information will be released on the full dose trial when available later in 2007. GeoVax’s AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV-1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.

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The human trials, utilizing GeoVax’s AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax’s DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.

Safe Harbor Statement

All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be determined to be safe for use in humans, GeoVax’s vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.

Contact: Melanie Nimrodi
Financial Relations Board

World Bank To Provide Thailand With $750,000 For HIV/AIDS Treatment Programs

The World Bank plans to provide Thailand with a $750,000, three-year grant aimed at providing HIV-positive people with increased access to antiretroviral drugs, Viroj Tangcharoensathien, program director for international health policy at the country’s Ministry of Public Health, said recently, Thailand’s Nation reports. More than 130,000 HIV-positive people in Thailand need access to antiretrovirals, and the number is increasing annually, according to the Nation. Under the grant partnership, the bank will help address funding issues associated with the country’s universal health care system, Viroj said. “We can’t rely on the ministry’s budget allocation alone,” Viroj said, adding that the partnership will seek other resources for health services. In addition, the project will provide training for nurses and doctors in an effort to overcome the shortage of health care personnel in the country, health ministry senior adviser Suwit Wibulpol-prasert said. The collaboration is a “step forward to sustainable development in this field and improving the country’s health care,” Suwit said. A separate partnership between the Thailand Center of Excellence for Life Sciences and the World Health Organization will aim to standardize clinical research into tropical diseases, the Nation reports. The partnership will focus on the prevention, diagnosis and treatment of diseases such as malaria, tuberculosis and dengue fever (Nation, 2/6).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Events Recognize National Black HIV/AIDS Awareness Day

Wednesday marks the seventh annual National Black HIV/AIDS Awareness Day, which aims to encourage blacks to get tested for HIV, to become educated about the virus and to receive treatment if necessary, the Chicago Tribune reports (Glanton, Chicago Tribune, 2/7). According to CDC data from 33 states published in November 2005 in the Morbidity and Mortality Weekly Report, the rate of new HIV cases among blacks has decreased an average of 5% annually since 2001, declining from 88.7 cases per 100,000 people in 2001 to 76.3 cases per 100,000 in 2004. However, blacks in 2004 were 8.4 times more likely than whites to be newly diagnosed with HIV. Blacks — who make up about 12.3% of the U.S. population — in 2004 accounted for about 49% of the estimated number of reported AIDS cases nationwide. In addition, HIV/AIDS in 2002 was the leading cause of death for black women ages 25 to 34; was among the top three causes of death for black men ages 25 to 54; and was among the top four causes of death for black women ages 25 to 54 (Kaiser Daily HIV/AIDS Report, 2/7/06). National Black HIV/AIDS Awareness Day is sponsored by the Community Capacity Building Coalition, a consortium of national minority-focused groups supported by CDC’s Division of HIV/AIDS Prevention (Kaiser Daily HIV/AIDS Report, 2/2). Events are occurring nationwide and announcements have been made in recognition of the awareness day. Highlights appear below.

Events

• Baltimore: The Institute of Human Virology will hold an open house to encourage HIV-positive people to adhere to their treatment regimens. Several clergy members and elected officials plan to receive HIV tests during the open house (Hille, Washington Examiner, 2/7).

• Delaware: The Delaware Health and Social Services Department and Beautiful Gate Outreach Center will sponsor its 6th Annual National Black HIV/AIDS Awareness Day Free Dinner Conference. The dinner will include comments from Carol Henderson Belton, an associate professor of English and black American studies at the University of Delaware, and Abbott Laboratories HIV specialist Robert Adams. In addition, speakers from local community AIDS groups will address dinner attendees (DHSS release, 2/6).
• Kentucky: This year’s observance in Kentucky will be themed “26 Years of AIDS is Enough, the Time to Deliver is Now.” The observance will feature distribution of educational material to local community events and churches, a town hall meeting, performances and workshops all focused on HIV/AIDS (Kentucky Department of Public Health release, 2/5).
• Memphis, Tenn.: The Memphis and Shelby County Health Department and local black leaders and organizations will sponsor events through Feb. 11., including discussion forums, HIV counseling and testing, and a news conference (Wilson, Eyewitness News, 2/5).
• Mississippi: HIV/AIDS advocate Marvelyn Brown on Tuesday addressed students at Jackson State University as part of the school’s commemoration of the awareness day (Jackson Clarion-Ledger, 2/6).
• Hampton, Va.: The Hampton University Student Government Association is hosting a seminar featuring HIV/AIDS-related fiction, music and poetry. Other colleges in the area are planning candlelight vigils and information sessions, and local churches have organized educational programs for ministers and the general public (Freehling, Hampton Roads Daily Press, 2/5).
• New York City: Victor Mooney, New York HIV/AIDS advocate and founder of South African Arts International, on Wednesday will unveil the design of an ocean rowboat that he will use to row across the Atlantic Ocean in an effort to raise awareness about HIV/AIDS in the U.S. and Africa, the AP/Long Island Newsday. Mooney will begin his trip on Dec. 1., which marks World AIDS Day 2007. Mooney in May 2006 attempted a similar trip that was unsuccessful (AP/Long Island Newsday, 2/7).
• Orange County, Fla.: The Orange County Health Department, the National Black Alcoholism and Addictions Council and other community partners are sponsoring several events, including a panel discussion, health fair, special screenings and the unveiling of a bus that displays HIV prevention messages (Rassel, Orlando Sentinel, 2/4).
• Tallahassee, Fla.: Sen. Frederica Wilson (D) and Rep. Curtis Richardson (D) will receive HIV tests at the state capitol on Wednesday to commemorate the awareness day and encourage residents to receive tests (Cotterell, Pensacola News Journal, 2/7).

Statements

• AIDS Action Committee of Massachusetts: AAC Executive Director Rebecca Haag said, “We must make sure that people living with HIV receive quality care and treatment, but at the same time, we must decrease the number of new” HIV cases through increased access to HIV prevention programs, particularly for minority communities (AAC release, 2/6).

• National Alliance of State and Territorial AIDS Directors: NASTAD on Wednesday announced it has released an issue brief examining HIV prevention efforts targeting black men who have sex with men (NASTAD release, 2/7).
• National Medical Association: NMA President Albert Morris in a statement said, “Special events such as free HIV/AIDS testing, town hall meetings, candlelight vigils and faith-based programs are being held throughout the country. However, we must do more to stop the spread of this disease.” He added that NMA “strongly recommends that physicians and other health care professionals offer routine HIV testing to their patients” (NMA release, 2/7).
• National Minority AIDS Council: The council on Monday announced the formation of the National Minority Policy Partnership on HIV/AIDS, an advocacy group that will lobby at local, state and federal levels to reduce HIV/AIDS among minority communities; ensure funding of HIV/AIDS prevention, diagnosis and treatment programs; reduce discrimination against black MSM; decrease the number of new HIV cases in prisons and the number of cases that occur through injection drug use; and stabilize communities at risk of HIV/AIDS (National Minority AIDS Council release, 2/5).
• NIH: In a statement to commemorate the awareness day, Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, said, “Some of the biggest challenges we face today are the misperceptions of and lack of knowledge about HIV/AIDS, and fear related to clinical research, particularly among African-Americans.” He added that he encourages blacks to “take part in the research effort in whatever way possible, as scientists, clinicians, community educators, advocates and study volunteers” (NIH release, 2/5).

Opinion Pieces
Several newspapers published opinion pieces responding to the awareness day. Summaries appear below.

• Jenice Armstrong, Philadelphia Daily News: U.S. blacks “need to stay reminded that HIV/AIDS is a scourge that shows no signs of going anywhere,” columnist Armstrong writes in a Daily News opinion piece, adding that blacks are “getting walloped especially hard” by the epidemic. According to Armstrong, it is “mind-boggling” that black people are more likely to become HIV-positive than whites (Armstrong, Philadelphia Daily News, 2/7).

• Jarvis DeBerry, New Orleans Times-Picayune: “To divide and conquer is classic military strategy, and if AIDS were a military strategist, he’d have the black community licked,” columnist DeBerry writes in a Times-Picayune opinion piece. According to DeBerry, too many people have tried to fight the spread of HIV “by looking for bogeymen within the community when, for their health’s sake, they ought to assume that everybody is a potential carrier of the disease and protect themselves accordingly.” DeBerry writes that because HIV/AIDS is widespread in the black “family,” people can “do one of two things about it. We can admit its presence and commit ourselves to fighting it together. Or we can bicker among ourselves and blame one another until there isn’t any family left” (DeBerry, New Orleans Times-Picayune, 2/6).
• Tony Norman, Pittsburgh Post-Gazette: “The spread of AIDS and HIV is the biggest public health emergency ever faced by blacks in this country,” columnist Norman writes in a Post-Gazette opinion piece. “Why, after more than two decades … are AIDS and HIV still taboo subjects in communities that can least afford to ignore them?” Norman asks, adding that “pretending” that HIV only affects other people “is a tragic fantasy” (Norman, Pittsburgh Post-Gazette, 2/6).
• Leonard Pitts, Miami Herald: The “main reason” that HIV/AIDS is so prevalent among blacks in the U.S. “is the silence, the closed-mouth social conservatism” and the “priggish moral rectitude of a people still ill at ease discussing sexuality, homosexuality, drug use and other realities,” columnist Pitts writes in a Herald opinion piece. He adds that the black community needs to “pull its collective head out of the sand” and “quit pretending homosexuality does not exist” and that injection drug use “does not exist” (Pitts, Miami Herald, 2/5).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Washington Post Columnist Examines Washington, D.C., Program Aimed At Curbing Spread Of HIV Among Injection Drug Users

Washington Post columnist Courtland Milloy on Wednesday examined PreventionWorks! — a privately funded needle-exchange program in Washington, D.C., that aims to curb the spread of HIV among injection drug users in the city. According to the district’s Administration for HIV Policy and Programs, injection drug use is the second leading mode of HIV transmission among men in the district, and it is the leading mode of transmission among women, Milloy writes. PreventionWorks! was launched in 1998 and provides counseling, treatment referrals and HIV tests to IDUs. Last year, the program had a budget of $600,000, all of which was donated. The program is run by Ron Daniels, four staff members and a group of volunteers, who visit 12 cites in the district six days weekly. Last year, the program provided 1,963 IDUs with access to educational materials, treatment referrals and clean needles. According to Milloy, the district has an estimated 9,700 IDUs. “The needle exchange is just the beginning,” Daniels said, adding, “We use the syringe to engage in conversations with those people nobody wants to talk to. We believe in meeting people where they are, treating them like human beings and helping them avoid catching and spreading diseases” (Milloy, Washington Post, 2/7).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Penn Study Suggests New Model For Testing And Discovery Of Anti-HIV Drugs

Researchers at the University of Pennsylvania School of Medicine are the first to show that a mouse protein, whose human equivalent is related to defense against HIV-1, inhibits the infection and spread of a mouse tumor virus. The study, which appeared online in advance of its print publication in Nature, provides a new model for the discovery and evaluation of anti-HIV drugs. HIV-1, like the mouse tumor virus, is a retrovirus which infects immune system cells. However, unlike HIV-1, the mouse virus causes breast cancer in mice.

“Our study is the first to show that the mouse equivalent to the human protein, called APOBEC3, actually inhibits a retrovirus in a live animal,” says lead author Susan R. Ross, PhD, Professor of Microbiology. The study is based on a mouse strain that does not have the gene for mouse APOBEC3, developed by co-author B. Matija Peterlin, PhD, University of California at San Francisco.

In this study, normal mice and mutant mice were injected with mouse mammary tumor virus (MMTV). Using a sensitive test for virus infection, the researchers found that lymph nodes from mutant mice were more infected than normal mice. At six days after injection, the lymph nodes near the injection site in mutant mice had four times more of the breast cancer-causing virus. By 18 days after infection, the virus had spread to other sites in the mice, and spleen cells from the mutant mice were seven-fold more infected by MMTV than spleen cells from normal mice. The research team is currently waiting to see if mutant mice develop breast cancer at a greater rate than normal mice.

“Although this study was performed with mice and used a mouse tumor virus for which there is no human counterpart, the mouse model of infection we have developed may be useful as a test system for evaluating drugs that augment the role of human APOBEC3 in defending against HIV,” says Ross. Since its discovery in 2002, the human equivalent to mouse APOBEC3 has been shown to defend some cell types against HIV-1 infection.

Some unanswered questions remain about APOBEC3 and how it can prevent virus replication and spread. Some cells cannot be infected with a retrovirus unless the virus has viral infectivity factor (Vif). Vif is a protein made by viruses like HIV that binds to APOBEC3 and marks it for destruction.

On the other hand, if APOBEC3 is not degraded by binding with Vif, it gets packaged into new virus particles. When these virus particles infect new cells, APOBEC3 causes mutations in virus RNA and DNA by a process called deamination. The mutations are so extensive that the new viruses cannot infect more cells, thus stopping the spread of the virus.

However, in the Nature study, no mutated MMTV virus was detected in the normal mice. “Thus, APOBEC3 must not use the deamination activity to mutate and limit the spread of MMTV,” says Ross. “We plan to study the mechanism of the antiviral activity in our model system.”

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This study was funded by the National Cancer Institute and the Slovenian Research Agency.

Co-authors in addition to Ross and Peterlin are Chioma M. Okeoma, from Penn, and Nika Lovsin, University of Ljublijana (Slovenia).

This release can be viewed at http://www.pennhealth.com/news.

PENN Medicine is a $2.9 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System.

Penn’s School of Medicine is ranked #2 in the nation for receipt of NIH research funds; and ranked #3 in the nation in U.S. News & World Report’s most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

The University of Pennsylvania Health System includes three hospitals, all of which have received numerous national patient-care honors [Hospital of the University of Pennsylvania; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center]; a faculty practice

Contact: Karen Kreeger
University of Pennsylvania School of Medicine

GlaxoSmithKline Commends $1.5 Billion Advance Market Commitment For Pneumococcal Vaccines

GlaxoSmithKline commended the governments of Canada, Italy, Norway, and the United Kingdom, as well as the World Bank, for agreeing to establish a pilot Advance Market Commitment to purchase and distribute new pneumococcal vaccines for the world’s poorest children.

“This innovative financing mechanism is a huge step forward and has the potential to save millions of lives,” said Jean StГ©phenne, President of GlaxoSmithKline Biologicals, the Global Vaccine Division of GlaxoSmithKline. “It sets the stage for a “win-win” situation: for donor countries, for vaccine manufacturers and, most of all, for the world’s children,” he added.

“This shows great vision on the part of the governments of Canada, Italy, Norway, and the United Kingdom, as well as the World Bank. We look forward to working with the World Bank and donor governments on the details of the plan.”

GSK’s pneumococcal vaccine candidate, which is in late-stage development, targets the most important prevailing pneumococcal strains worldwide. It includes three serotypes that are not contained in any currently available pneumococcal vaccine, and are of special importance in the developing world. And, these particular serotypes maybe associated with a higher risk of hospitalization, severe pneumonias, and meningitis outbreaks in Africa. GSK’s vaccine candidate also targets a second pathogen, non-typable Haemophilus influenzae, known to be a major cause of ear infections worldwide.

Advance market commitments, or AMCs, are designed to speed the development of new vaccines and to accelerate their distribution to the world’s poorest countries. They are meant to help end the 15 to 20 year delay it has traditionally taken vaccines to reach developing countries. By guaranteeing the size of the purchase commitment, AMCs are meant to give vaccine makers the confidence to develop new vaccines, and to build enough production capacity to satisfy global demand.

AMCs have moved from academic theory to the real world with remarkable speed. Last year, Scientific American magazine cited the “unprecedented creativity” of the idea, which has garnered broad support in global public health circles. The pilot AMC for pneumococcal vaccines extends the public-private engagement to the distribution of new vaccines, a trend that began in earnest with the creation of the GAVI Alliance.

Jean StГ©phenne said he hoped a successful pilot AMC for pneumococcal vaccines would pave the way for similar commitments by donors to purchase future vaccines. “In particular, the AMC mechanism would be ideal for vaccines against AIDS, malaria and TB,” he said.

GlaxoSmithKline is one of the leaders in the pharmaceutical industry in R&D for diseases of the developing world. GSK is the only company developing medicines to treat, and vaccines to prevent, the WHO’s three priority infectious diseases: AIDS, malaria, and TB. GSK conducts a portion of its developing country disease R&D through public-private partnerships with a range of groups supported by donor governments and such charities as the Bill & Melinda Gates Foundation.

GSK is also a leading supplier to the developing world through UNICEF and GAVI. The company pioneered tiered pricing for its vaccines, with lower pricing for the public sectors of the world’s poorest countries

Background on Pneumococcus

Pneumococcus is a bacterium that causes meningitis, pneumonia, and ear infections. It kills 1.6 million people every year, including a million children under the age of five, according to WHO. In clinical trials, GSK’s vaccine candidate appears to be effective against pneumococcal diseases with greatest incidence in the developing world. It is expected that further studies will confirm the protection potential of GSK’s vaccine candidate against acute otitis media caused by non-typable Haemophilus influenzae. GSK expects to file its vaccine to regulatory authorities by end 2007.

About GSK Biologicals

GSK is one of the world’s leading vaccine manufacturers. The majority of GSK’s activities in the field of vaccine research, development and production are conducted at its Biologicals headquarters in Rixensart, Belgium. GSK employs more than 1,500 research scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide.

In 2005, GSK distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and developing world, more than 3 million doses per day.

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit http://www.gsk.com.

The governments of Canada, Italy, Norway, and the United Kingdom, along with the World Bank, have agreed to establish a US$1.5 billion pilot Advance Market Commitment (AMC) to stimulate the development of new pneumococcal vaccines for the world’s poorest countries. The formal announcement will be made in Rome on Friday, 9 February.

Pneumococcus is a bacterium that causes meningitis, pneumonia, and ear infections. It kills 1.6 million people every year, including a million children under the age of five, according to the World Health Organisation.

What follows is a reaction statement from GSK Biologicals, the Global Vaccine Division of GlaxoSmithKline PLC. GSK is one of the world’s largest makers and developers of vaccines and is developing a new vaccine against pneumococcal disease and non-typable Haemophilus influenzae infection.

GlaxoSmithKline
http://www.gsk.com

First Large-Scale HIV Vaccine Trial In South Africa

A large-scale clinical trial of a candidate HIV vaccine – which previously showed promise in smaller studies in the United States and elsewhere – has now opened in South Africa. The study plans to enroll up to 3,000 HIV-negative men and women, making it the largest African HIV vaccine trial to date.

Conducted jointly by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN), the trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study vaccine, provided by Merck & Co. Inc. (Whitehouse Station, NJ), contains copies of only three HIV genes, not the entire virus, so it is impossible for a trial volunteer to become infected from the vaccine.

“Our best hope of ending the AIDS epidemic is a safe and effective vaccine,” says NIH Director Elias A. Zerhouni, M.D. “To achieve that goal requires the concerted effort of governments, scientists and private industry as well as participation by well-informed volunteers.”

“We applaud the South Africans for bringing this important trial to fruition. This international partnership exemplifies the model of collaboration needed to defeat HIV/AIDS,” says NIAID Director Anthony S. Fauci, M.D.

In South Africa the trial is called Phambili (“moving forward”). Also known as HVTN 503, it is a Phase IIb “test-of-concept” trial, the first such vaccine study in South Africa. This type of trial is designed to provide preliminary information on vaccine efficacy and thus enable researchers to decide whether or not to conduct a larger Phase III efficacy trial that could lead to licensure.

In smaller trials, the vaccine was found to be safe and to stimulate cellular immune responses against HIV in more than half of volunteers. To date, more than 1,800 people have received at least one injection. Two years ago, the first Phase IIb trial of the vaccine opened at sites in the United States, Canada, South America, Australia and the Caribbean (see http://www3.niaid.nih.gov/news/newsreleases/2005/mercktrial.htm), areas where a subtype of HIV called clade B predominates. That trial is ongoing.

As in that study, the main objectives of HVTN 503 are to determine whether the candidate vaccine can prevent HIV infection or, in those who do become infected, lower the level of HIV early on. Additionally, the new trial will determine if the vaccine, which is based on clade B HIV, has the potential to protect against the HIV clade C subtype prevalent in South Africa. Immune responses in the first several hundred volunteers will be assessed to ensure the vaccine induces promising immune responses in this population against the clade C virus before proceeding to full enrollment.

Study volunteers must be healthy, sexually active, HIV-negative men and women, ages 18 to 35 years old. Investigators will assign them at random to receive either the test vaccine or an inactive placebo injection. The trial is double-blind, meaning that neither the researchers nor the volunteers know which a participant has received. All volunteers will be regularly counseled about ways to reduce their risk of acquiring HIV, and they will be given condoms. Access to care and treatment for sexually transmitted infections will be provided, and because recent findings indicate that medical circumcision can reduce the risk of HIV transmission from women to men, access to medical circumcision will also be provided to male participants who desire it.

In South Africa, the trial is led by Glenda Gray, MBBCH, FCPaeds (SA), of the Perinatal HIV Research Unit, University of the Witwatersrand, based at the Chris Hani Baragwanath Hospital in Soweto. James Kublin, M.D., M.P.H., of Fred Hutchinson Cancer Research Center, Seattle, serves as study co-chair. The study is expected to recruit volunteers at five sites in South Africa, located in Soweto, Cape Town, Klerksdorp, Medunsa and Durban.

According to Dr. Gray, the study team has actively sought community endorsement of and support for this clinical trial, both of which are critical to its success. “Our communities here in South Africa are faced with the burden of HIV on a daily basis, and the trial investigators and study team have spent years developing a rapport with the community so that together we can move forward in our quest to identify improved approaches to prevent new HIV infections.”

The test vaccine contains a weakened adenovirus that serves as a carrier for three clade B HIV genes. Adenoviruses are among the main causes of upper respiratory tract ailments such as the common cold. Because the vaccine contains only three HIV genes housed in weakened adenoviruses, study participants cannot become infected with HIV or get a respiratory infection from the vaccine. The study aims to determine if the HIV genes will induce a cellular immune response, producing immune cells that recognize and kill cells infected with HIV.

The South African Medicines Control Council, the South African Department of Agriculture and the U.S. Food and Drug Administration have reviewed the trial and allowed the study to proceed. In order to conduct the trial, sites also are required to obtain institutional ethics and biosafety committee approvals.

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NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH) – The Nation’s Medical Research Agency – includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

NIAID-Sponsored Vaccine Trial (HVTN 503) in the Republic of South Africa Questions and Answers http://www3.niaid.nih.gov/news/QA/503qa.htm

HIV Vaccine Trials Network (HVTN) http://www.hvtn.org/

South African AIDS Vaccine Initiative (SAAVI) http://www.saavi.org.za/

Contact: NIAID News Office
NIH/National Institute of Allergy and Infectious Diseases

WFP Resumes Programs Providing Food To People With TB, HIV In Cambodia After Receiving Aid From Spain, U.S.

The World Food Program has resumed its programs providing people living with HIV and tuberculosis in Cambodia with access to food after receiving aid from Spain and the U.S., the agency said on Thursday, the AP/International Herald Tribune reports (AP/International Herald Tribune, 2/8). Thomas Keusters, country director for WFP’s Cambodia office, said recently that WFP had been “forced to suspend” the programs because of funding shortages. The programs distribute food rations to 18,000 people with TB and 70,000 people with HIV. They also ensure that HIV-positive people and people with TB needing medicine are connected with food distribution points. “The sick need food first before taking medicines,” Haidy Ear-Dupuy — advocacy manager at the Phnom Penh, Cambodia, office of World Vision — said, adding, “You cannot take medication on an empty stomach. You must maintain a balance” (Macan-Markar, Inter Press Service, 2/6). WFP in a statement on Thursday said that Spain has provided about $650,000 and that the U.S. has provided 6,100 tons of legumes, as well as 2,370 tons of vegetable oil, for a period of three years. WFP three weeks ago announced that it needed at least $10 million to run its programs in Cambodia through July (AP/International Herald Tribune, 2/8). Keusters said WFP welcomed the donations but added that more “urgent donations” are needed (Agence France-Presse, 2/8). HIV prevalence in Cambodia is 1.6%, the highest in Southeast Asia, according to Inter Press Service (Inter Press Service, 2/6).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

House Spending Resolution Contains Provision That Would Cancel Funding For Program To Expand HIV Services To Pregnant Women, Infants

The $463 billion spending resolution (HJ Res 20) for fiscal year 2007 passed last week by the House contains a provision that cancels funding for a program aimed at supporting state-level efforts to provide HIV prevention, early diagnosis, and counseling services to pregnant women and infants, CongressDaily reports (Cohn, CongressDaily, 2/7). The House last week voted 286-140 to approve the spending resolution. The resolution allocates an additional $75.8 million in funding for the Ryan White CARE Act, which provides care and services to people living with HIV/AIDS in the U.S., to bring total funding to $1.2 billion (Kaiser Daily HIV/AIDS Report, 2/1). According to CongressDaily, Sen. Tom Coburn (R-Okla.) sponsored the program, which would allocate $30 million annually in grants for states to provide women and infants with HIV/AIDS prevention, testing, counseling and treatment. The program was included in the CARE Act reauthorization bill (HR 6143), which was signed by President Bush in December 2006, CongressDaily reports. To be eligible for the grants, states would have been required to implement policies providing voluntary HIV testing among pregnant women, clients at sexually transmitted infection clinics and substance abuse centers. States also would have to implement provisions for universal HIV testing among infants, CongressDaily reports. Democratic lawmakers said few states would qualify for the $30 million requested for the program. According to CongressDaily, Coburn on Thursday indicated in a letter to Minority Leader Mitch McConnell (R-Ky.) that he would place a “hold” on the budget resolution. “Senators should not be denied the opportunity to debate and amend such a far-reaching bill that funds nearly all aspects of the federal government’s domestic and foreign aid programs,” Coburn said (CongressDaily, 2/7).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.