16 November 2010 Last updated at 00:04 GMT
Malaria vaccine: Inside look at first human trial
The first clinical trial for a vaccine against the most widespread strain of malaria, Plasmodium vivax, is now under way at the Walter Reed Army Institute for Research (WRAIR), near Washington DC. The BBC's Jane O'Brien speaks with those heading the trial and individuals who are being bitten by infected mosquitoes to help further the research.
US army medic Joseph Civitello admits that becoming deliberately infected with malaria - one of the world's deadliest diseases - is "definitely nuts".
But without such volunteers, it would be almost impossible to test a new vaccine aimed at protecting the military overseas and preventing some of the estimated 300 million cases of malaria that occur every year.
First Sgt Civitello is part of the world's first clinical trial of a vaccine against Plasmodium vivax - the most widespread strain of malaria.
It's not as deadly as Plasmodium falciparum, which is endemic in Africa and kills millions of people, but it can resurface years after infection and still make its victims extremely ill.
"It was weird because I did this knowing I was going to get sick," says Sgt Civitello.
"Fortunately I'm in a hotel room with doctors and nurses nearby and not out in the woods somewhere."
Unlike most of the other volunteers in this unique trial, Sgt Civitello wasn't given the test vaccine.
Human test subjects
He's part of a small control group - a human yardstick - needed by doctors to confirm that all the study participants have been infected.
And as predicted, about 10 days after being bitten by mosquitoes in a laboratory, he displayed all the symptoms of malaria.
"It started out with a headache, then a general malaise throughout the day. My eyeballs hurt, and I was really sensitive to cold and hot - my skin was sensitive and I had sweats and chills all night long. It was like extremely bad flu," Sgt Civitello said.
Twenty-seven other volunteers in the study had been given varying doses of the vaccine for several months prior to infection.
Developed by scientists at the Walter Reed Army Institute of Research, it consists of a protein that stimulates the body's immune system and triggers its natural defences against the disease.
Then, at the beginning of November, they were bitten by mosquitoes imported from Thailand and infected with Plasmodium vivax malaria.
A small carton containing the insects was placed on their arms for several minutes and repeated until they received five bites each, making infection a certainty.
"What makes this process unique is that we don't know whether a vaccine has worked unless it is exposed to a pathogen - in this case malaria. And malaria can only be transmitted through the bite of a mosquito," says Col Christian Ockenhouse, director of the Malaria Vaccine Research Programme at WRAIR.
He adds: "What we do here plays a critical, pivotal role in the fight against malaria. Without this model of challenging the human body with malaria, we would be unable to effectively develop and figure out whether a vaccine works or not."
"It costs millions of dollars to test any vaccine and if we can safely eliminate vaccines that don't work and push into further trials those that do show promise, it will save millions of dollars."
Malaria vaccines have remained elusive because of the parasite's ability to rapidly evolve and adapt to its human host.
An international movement
The Gates Foundation has spent $1.4bn fighting the disease and the global campaign involves many organisations from WRAIR to big pharmaceutical companies, such as GlaxoSmithKline.
The US military has been at the forefront of developing vaccines ever since the Civil War because of malaria's ability to disrupt operations if soldiers get sick. The Plasmodium vivax strain is a particular problem for troops serving in Afghanistan.
At the moment, the only other way to prevent infection is to avoid mosquito bites by using bed nets or insecticides.
But a trial for a Plasmodium falciparum malaria vaccine, involving 16,000 children in Africa, could be completed next year.
Volunteers in the world's first Plasmodium vivax malaria vaccine trial are given several thousand dollars in compensation.
They say the money is an incentive, but most take part because they want to further medical science.
"My dad was a doctor, and I always knew that in order to advance the medical field you need human subjects," says Mengee Shan, a volunteer in the control group.
"And being a science major myself, I felt I would have to rethink my career if I couldn't dedicate myself to doing something like this, especially if I am going to ask others to take part in my medical projects."
Renee Kruger, a single mother from Maryland, says the cash will help pay for Christmas but feels she's doing something worthwhile.
"Some people may be scared of doing this, but every drug or over-the-counter medicine needed to be tested on a human, so that's why I'm doing it."
Twelve days after being bitten, she exhibits no signs of infection, but other vaccine testers are showing positive for malaria.
Scientists say it'll be another week before they can determine full extent of the trial's success or failure.
The vaccine may have offered limited protection to some of the volunteers or be completely effective in others.
Volunteers in the Plasmodium vivax malaria vaccine trial are paid several thousand dollars each
In any event, the results will be used to develop better vaccines in the future.
"It typically takes 15 to 20 years to develop a new drug or vaccine that goes to market," says Col Ockenhouse.
"But the world doesn't have 15 or 20 years to wait for another malaria vaccine - so anything we can do to rapidly progress this development process is most important."
Meanwhile, the volunteers are staying at a hotel in Maryland, where they can be monitored around the clock.
Some of the rooms have been converted into a clinic and laboratory so that blood samples can be tested immediately for any signs of malaria.
If the volunteers do succumb they are instantly treated with drugs to ensure there will be no lasting consequences of the trial.
Source: BBC News http://www.bbc.co.uk/news/world-us-canada-11760859
**To Read the full article and watch the VDO clip, please go to the BBC News page.
HIV Vaccine Study First to Show Some Effectiveness in Preventing HIV
24 September 2009—A Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. According to final results released by the trial sponsor, the U.S. Army Surgeon General, the prime boost combination of ALVAC? HIV and AIDSVAX? B/E lowered the rate of HIV infection by 31.2% compared with placebo.
In the final analysis, 74 placebo recipients became infected with HIV compared to 51 in the vaccine regimen arm. The efficacy result is considered statistically significant with a 95% confidence interval greater than zero. The vaccine regimen had no effect on the amount of virus in the blood of volunteers who became HIV-infected during the study.
This is the first time that an HIV vaccine candidate has reduced the risk of HIV infection in humans. This finding has important implications for the design of future HIV vaccines and how they are tested, however the public health benefits are unclear and require further study. In addition, the data show that the vaccine regimen is safe.
Collaborating partners on this study, referred to as RV144, include the U.S. Army, the Thai Ministry of Public Health, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, Mahidol University, The Royal Thai Army, AFRIMS-Thai component, sanofi pasteur, and Global Solutions for Infectious Disease (GSID). The collaborators are already working with external experts to determine the need for additional studies on this vaccine regimen.
The U.S. Army Medical Directorate – Armed Forces Research Institute of Medical Sciences (USAMD-AFRIMS), a special foreign activity of the Walter Reed Army Institute of Research (WRAIR) in Washington, D.C. and of the US Army Medical Research and Materiel Command (USAMRMC), helped to execute the trial in Thailand on behalf of the Sponsor. With enthusiastic support from the US Ambassador to Thailand, this successful vaccine trial is another example of long–standing, productive collaboration between US and Thai military and civilian scientists to conduct basic and applied research on infectious diseases of global health and military importance.
The U.S. Army would like to thank the more than 16,000 Thai men and women who consented to participate in this trial and the efforts of the Thai Ministry of Public Health and all collaborators for their hard work in achieving this important milestone.
Phase III HIV Vaccine Trial Background
The Thai Phase III clinical vaccine trial (RV 144) tested a prime boost vaccine strategy that combined two vaccines based on strains (subtypes) of HIV that circulate in Thailand. The first, or “prime” vaccine, known as ALVAC HIV, was developed by sanofi pasteur and the booster vaccine, AIDSVAX B/E, was originally developed by VaxGen and is now licensed to Global Solutions for Infectious Diseases.
The study, which began in 2003, was designed to test the vaccine strategy’s ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected after they enrolled in the study.
More than 16,000 HIV-negative men and women between the ages of 18 to 30 participated in the study; half of these participants received the prime-boost vaccine regimen and half received placebo. Volunteers received vaccinations over the course of six months, and were followed for an additional three years. Before agreeing to participate, all volunteers were informed of the potential risks associated with receiving the experimental vaccine regimen used in this study and consented to participate in the study. Volunteers continued to receive an HIV test every six months for three years following vaccination, in addition to counseling on how to prevent becoming infected with HIV.
For additional information regarding the trial, visit www.hivresearch.org
Media inquiries can be directed to Tawn Chatchavalvong of Hill &Knowlton, Thailand at +66 (2) 6273501 ext. 118 or firstname.lastname@example.org.
On September 16, 2009, the U.S. Ambassador Eric G. John; MG Krisada Duangurai,
the Director General, AFRIMS; together with COL James W. Boles, Commander, USAMC-AFRIMS officiated the ribbon cutting ceremony opening the AFRIMS Biosafety Level-3 (BSL-3) Laboratory. RTA-AFRIMS and USAMC-AFRIMS have worked shoulder to shoulder for over 48 years and have played a significant role in the development of vaccines and drugs currently in use worldwide such as Hepatitis A, Japanese Encephalitis, and Malaria. This BSL-3 Lab is a significant contribution to AFRIMS, it is the first and only one in SE Asia which meets strict US Department of Army safety standards. The BSL-3 Lab is very important as it expands AFRIMS capacity to conduct research and assist with outbreaks of BSL-3 level agents such as Chikungunya and other biological agents located throughout SE Asia. The ceremony ended with a brief tour and a celebratory cake, dessert and refreshments reception attended by many AFRIMS employees.
Dr. John L. VandeBerg and his Team visit AFRIMS: September 7, 2009
John L. VandeBerg, Ph.D. is Chief Scientific Officer (CSO) of the Southwest Foundation for Biomedical Research (SFBR), Director of the Southwest National Primate Research Center (SNPRC), Scientist in the Department of Genetics at SFBR, and Professor of Pathology and of Cellular and Structural Biology at The University of Texas Health Science Center at San Antonio (UTHSC-SA)
Dr. VandeBerg’s research interests are focused on genetic and environmental factors that influence risk for common chronic diseases and parasitic diseases. He works with nonhuman primate and marsupial models, as well as cell cultures and human subjects. He is currently investigating the genetics of susceptibility to coronary heart disease, the genetic basis of susceptibility to disease progression in Chagas disease (caused by infection with Trypanosoma cruzi), and aspects of UV-radiation induced cancers in opossums as well as human cancers transplanted into opossums. Recently, he established a program to develop and test a DNA vaccine for tuberculosis. Dr. VandeBerg has authored or co-authored more than 300 scientific articles and book chapters.
Dr. VandeBerg is recognized for his pioneering work in developing a small marsupial, the gray short-tailed opossum from South America, as a standard laboratory animal now used extensively as a model for research on human diseases, developmental biology, and evolutionary biology. He and his colleagues also have developed a unique pedigreed colony of baboons which are genotyped at 300 microsatellite marker loci and used extensively for whole genome scans of physiological characters related to human diseases.
>> Read More
AFRIMS team at Disease Surveillance Workshop, Vientiane, Laos
AFRIMS provided a team of experts to the United States Pacific Command (PACOM) Disease Surveillance Workshop 9-12 June in Vientiane, Laos. The workshop was organized by the National Avian and Human Influenza Coordinating Office (NAHICO) of Laos and the PACOM team from the Office of International Health at Thirteenth Air Force from Hickam Air Force Base in Hawaii. The workshop provided an overview to 40 specialists from the Military Medical Department (MMD) and Ministry of Health (MOH) on the laboratory and epidemiology concepts in disease surveillance. The workshop was the opening event of a cooperative program with PACOM and NAHICO to enhance disease surveillance capacity within the MMD, improving the capability of health experts within the Lao PDR to detect, respond and contain infectious diseases.
The following AFRIMS personnel provided talks and demonstrations: COL Julie Pavlin on disease surveillance; Pakornpat Suphanich, Rapida Padmasankha and Nucharee Thongsen from the GEIS Dept on database creation, mapping and epidemiologic software; Duangrat Mongkolsirichaikul and Wiliaiwan Sridadech from the Virology Dept on influenza surveillance and diagnosis; LTC Mark Fukuda from the Immunology Dept on malaria drug resistance surveillance; Dr. Ananda Nisalak from the Virology Dept on dengue epidemiology and diagnosis; LTC Kwanjai Viputtigul and LTC Pradith Kaewsatien from the Research Dept on leptospirosis and rickettsia epidemiology and diagnosis; Siriporn Sornsakarin and Apichai Srijan from the Enterics Dept on diarrheal pathogens and antibiotic resistance in Asia; and Dr. Alongkot Ponlawat and Surachai Leepitakrat from the Entomology Dept on vector identification and surveillance.
Members from the Laos Military Medical Department will be attending a training program at AFRIMS from August 17-28 to further their knowledge and capabilities to perform disease surveillance. This program is made possible through support by the Armed Forces Health Surveillance Center/Department of Defense Global Emerging Infections Surveillance and Response Systems (AFHSC/DOD-GEIS).
Read about this Workshop in Laos Newspapers >> Vietiane Times | Kongthap Pasaxon Lao Daily
[Click on image to enlarge]
March 18, 2009
The United States Supports Vietnam in HIV Laboratory Quality Assurance
With support from the U.S. Department of Defense (DoD) under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), an HIV Laboratory Quality Assurance Workshop is being conducted in Ho Chi Minh City this week. The four-day workshop aims to develop the capacity of laboratory officers and technicians at PEPFAR-supported sites, with regards to HIV Laboratory Quality Assurance practice standards.
Participants from seven PEPFAR supported laboratories are being trained in best practices introduced by technical experts from the U.S. Armed Forces Research Institute of Medicine Sciences. This workshop is the first of its kind which has focused on building expertise among laboratory technicians in Vietnam.
Since 2004, PEPFAR has provided more than US $232 million to support the provision of comprehensive HIV prevention, care and treatment services in Vietnam. Vietnam is one of fifteen PEPFAR focus countries, and the only PEPFAR focus country in Asia.
Malaria patients in the intensive care ward of the provincial hospital in Battambang, Cambodia.
(Thomas Fuller/International Herald Tribune)
Spread of malaria feared as drug loses potency
By Thomas Fuller
Tuesday, January 27, 2009
TASANH, Cambodia: The afflictions of this impoverished nation are on full display in its western corner: the girls for hire outside restaurants, the badly rutted dirt roads and the ubiquitous signs that warn "Danger Mines!"
But what eludes the naked eye is a potentially graver problem, especially for the outside world. The parasite that causes the deadliest form of malaria is showing the first signs of resistance to the best new drug against it.
Combination treatments using artemisinin, an antimalaria drug extracted from a plant used in traditional Chinese medicine, have been hailed in recent years as the biggest hope for eradicating malaria from Africa, where more than 2,000 children die from the disease each day.
Now a series of studies, including one recently published in The New England Journal of Medicine and one due out soon, have cemented a consensus among researchers that artemisinin is losing its potency here and that increased efforts are needed to prevent the drug-resistant malaria from leaving here and spreading across the globe. >>> Read Full Article Here
|US Army, Thai Researchers Close In on Vaccine for Dengue Fever
|By Prospero Laput
02 January 2009
The reports Dengue fever infects up to 50 million people around the world each year, killing thousands. The disease, common in tropical countries around the world, has undergone a resurgence in the past few decades.
Dengue, no ordinary fever
As dengue potentially threatens the continental United States with reported cases on the Texas-Mexico border, U.S. Army researchers in Bangkok are closing in on a vaccine to conquer this mosquito-borne disease.
|Child diagnosed with the Dengue disease
It seemed like an ordinary fever, but after Sarapee's son was given medication to reduce his temperature, his nose began to bleed.
"The other hospital gave me the medicine and told me to take him back home," she said. "No blood-test even if he has a high fever. They might have known if they did a blood test."
The doctors did not realize Sarapee's son had dengue fever, also known as "breakbone fever," because victims feel intense joint and muscle pain. Its symptoms are often confused with influenza. But many patients develop a deadly complication called dengue hemorrhagic fever or DHF. >> more
Click here to Read the FULL ARTICLE
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