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Topic: Vaccine trials

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	H5N1 Avian Flu Vaccine Trials (Site not responding. Last check: 2007-10-26)
		This trial, which is completed, evaluated the safety of the vaccine and its ability to generate an immune response (immunogenicity).
		NIAID has completed a Phase I trial to evaluate the response to intradermal (under the skin) administration of the sanofi pasteur H5N1 vaccine; the purpose of the study is to determine if a smaller intradermal dose may be as immunogenic as a larger dose administered intramuscularly (see question 8).
		The pediatric trial is being conducted at three VTEUs: the University of Maryland, UCLA and Saint Louis University.
	www3.niaid.nih.gov /news/newsreleases/2005/H5N1QandA.htm (1863 words)

	HIV Vaccine Trials Unit
		A vaccine trial is a standard way to test a specific study vaccine so that researchers can prove that the study vaccine is safe, and can find out more about whether it might work to prevent or fight disease.
		Volunteers for vaccine trials should be HIV negative and planning to stay in the Seattle area for the duration of the study (at least 12-24 months).
		Trial participants play a very important role in the search for an HIV vaccine, and the safety and rights of participants are given the highest priority.
	www.seattlevaccines.org /faqs.html (2505 words)

	The Body: Looking at AIDSVAX and other vaccine trials
		This vaccine is made from entire viruses that have been inactivated (killed) in the laboratory and are intended for uninfected individuals.
		Once vaccinated with a live weakened (attenuated) strain of HIV that is capable of replicating but not causing illness, an individual would theoretically be protected from disease-causing (pathogenic) strains, should they become exposed to them.
		DNA vaccines are relatively inexpensive to manufacture, and in animal studies have shown an ability to generate cellular immune response (the production of cells that kill infected cells) and humoral immune response (the production of antibodies that destroy circulating virus).
	www.thebody.com /apla/oct98/aidsvax.html (1057 words)

	HIV Vaccine Trials Unit :..Saint Louis University School of Medicine
		Oligomeric gp140 vaccine may help the body produce a type of antibody that is better than antibodies made by single-copy proteins of this type.
		Vaccines are substances used by medical professionals to try to prevent infection and to fight or prevent disease.
		Most vaccines are made of proteins (natural substances that the body uses as building blocks) and are injected into the body.
	medschool.slu.edu /hvtu/index.phtml?page=currentstudies (1498 words)

	Ethical and Legal Issues in AIDS Vaccine Trials - Human Rights Magazine Fall 2004
		The UNAIDS ethics guidelines recommend that any HIV vaccine demonstrated to be safe and effective should be made available as soon as possible to all research trial participants, as well as other populations at high risk of HIV infection, and that plans at the initial stages of HIV vaccine development ensure the availability of benefits.
		Many of the legal concerns that apply to HIV vaccine trials, and that likely would apply to an approved vaccine, relate to stigma and discrimination against people who are presumed to be infected or are assumed to be at a higher risk for infection because of their participation in vaccine trials.
		Additional concerns relate to the fact that vaccine volunteers may be considered at higher risk for HIV infection merely because of their participation in a vaccine trial.
	www.abanet.org /irr/hr/fall04/trials.htm (1440 words)

	AEGiS-IRIN: HIV/Aids Vaccine Trials Underway (Site not responding. Last check: 2007-10-26)
		Trials of a preventive HIV/AIDS vaccine began on human volunteers on Monday in Entebbe, Uganda.
		The vaccines are currently the only ones being tested on humans that are tailored for the subtype of HIV most common in eastern Africa - subtype A. Most other vaccines focus on the B strain, which is found in the US and Europe.
		The two vaccines - one a naked DNA formulation, and the other constructed from a weakened pox virus - were developed as part of an IAVI-sponsored partnership between research teams at the University of Oxford, in England, and the University of Nairobi, in Kenya.
	www.aegis.com /news/IRIN/2003/IR030212.html (623 words)

	ACS :: A Vaccine Against Cancer?
		In the lung cancer vaccine trial, for instance, the most common side effect was relatively mild irritation at the injection site.
		Patients who are interested in participating in a trial of a cancer vaccine can turn to the NCI's Web site for information, or talk to their doctors.
		Schlom said many cancer centers are conducting vaccine trials, and may be able to point patients to a trial that is right for their particular situation.
	www.cancer.org /docroot/NWS/content/NWS_1_1x_A_Vaccine_Against_Cancer.asp (940 words)

	AEGiS-Reuters: Italy Launches New AIDS Vaccine Trials (Site not responding. Last check: 2007-10-26)
		The new vaccine is based on Tat, a small protein essential for the virus replication, and aims to stop the disease spreading.
		Initial tests of the Tat vaccine at three Italian clinics are expected to take about a year and will aim to ensure it is harmless to humans.
		Although 12 vaccine candidates are now in human trials, the International AIDS Vaccine Initiative (IAVI) estimates less than one percent of the 70 billion dollars spent each year on global health product research is dedicated to AIDS vaccine research.
	www.aegis.com /news/re/2003/RE031132.html (552 words)

	NIDA NOTES - Nicotine Vaccine Moves Toward Clinical Trials
		The hypothesis is that the vaccine may inhibit nicotine's "priming effect"-the phenomenon in which a formerly addicted individual experiences an increased desire to use a drug after a single exposure, which contributes to relapse.
		When rats were injected simultaneously with a nicotine solution and the vaccine, the antibodies that reduced nicotine levels in the rat brains also reduced nicotine dependence.
		Thus it may be possible to vaccinate a smoker while he or she is still using tobacco so that adequate antibodies will be in place at smoking cessation.
	www.nida.nih.gov /NIDA_Notes/NNVol15N5/Vaccine.html (639 words)

	Many Distrust AIDS Vaccine Trials - HIV: health and medical information about HIV and AIDS (Site not responding. Last check: 2007-10-26)
		While vaccines now protect against a variety of illnesses from chicken pox and polio to smallpox, scientists say the AIDS virus has turned out to be a much tougher customer.
		Still, researchers are continuing to develop vaccines, and about 30 clinical trials are now underway in the United States, Murguia said.
		Also, 47 percent of the fls surveyed believe that an HIV vaccine already exists and is being kept secret; 27 percent of the Latinos believed that, as did 13 percent of gay and bisexual men.
	www.medicinenet.com /script/main/art.asp?articlekey=55418 (672 words)

	Clinical Trial: Anthrax Vaccine Clinical Trials
		A vaccine for humans, composed of a cell-free preparation absorbed onto alum, was licensed in 1970 after successful clinical trials.
		Vaccination against anthrax in the U.S. was confined to individuals at risk such as wool sorters and some veterinarians until the prospects were raised of B. anthracis being used as a weapon after the Iraq war.
		Individuals who are HIV positive, have abnormal liver function, had anthrax, or received anthrax vaccine, have received or intend to receive an experimental vaccine or medication within 30 days of injection of the experimental anthrax vaccine.
	www.clinicaltrials.gov /ct/gui/show/NCT00114621?order=4 (882 words)

	More women and adolescents needed in HIV vaccine clinical trials
		Clinical trial enrolment needs to be more inclusive, so the benefits of research are more fairly distributed," said Dr Ruth Macklin, co-Chair of the meeting and a bioethics professor at the Albert Einstein College of Medicine in New York city.
		For instance, the participation of a minor in a clinical trial would require the parents' or guardian's consent, and youth must fully understand what receiving a candidate HIV vaccine does or does not mean for their health.
		Vaccines for several infectious diseases have shown varying levels of efficacy in different gender, age and racial or ethnic sub-groups.
	www.news-medical.net /?id=4454 (888 words)

	Vaccine news
		Trials are now testing vaccines of various kinds on patients with indolent lymphomas, and some aggressive lymphomas as well.
		After a rest period the vaccine is given with the goal of teaching the immune system to kill off any residual cells that have survived the chemotherapy.
		Another study (Favrille) is testing the ability of the Id vaccine to regress tumors in previously treated patients without pretreatment with chemotherapy.
	www.lymphomation.org /vaccines.htm (1104 words)

	BBC News \| HEALTH \| Alzheimer's vaccine trials 'promising'
		It is hoped the further trials will produce the same results as tests on mice which showed the vaccine was able to protect against Alzheimer's, if the injection was given at an early age.
		When the first indications of the vaccine's safety were announced last July at the World Alzheimer's Society in Washington DC, Dr Dale Schenk, vice president of discovery research at Elan Pharmaceuticals, said: "We are extremely pleased with the progress of our phase one trials which have shown that AN-1792 is well tolerated by the patients.
		The vaccine is a synthetic form of naturally occurring beta amyloid protein, the main component of the plaques.
	news.bbc.co.uk /1/hi/health/1452295.stm (571 words)

	CNN - AIDS vaccine trials: a moral and ethical challenge - June 28, 1998
		Trials of this nature raise the risk of false security among participants, according to Dr.
		The vaccine itself poses no risk of infecting participants, but there are other moral and social challenges facing trial participants- issues of privacy and confidentiality.
		Vaccine trials in the United States will take place in Chicago, Denver, Los Angeles, Philadelphia and St. Louis.
	www.cnn.com /HEALTH/9806/29/vaccine.trial.ethics (602 words)

	Harvard School of Public Health AIDS Initiative: Scientific Research-Vaccine Development
		Along with the laboratory investigations dedicated to developing a safe and effective HIV vaccine for southern Africa, the Botswana–HAI Partnership is currently collaborating with local, regional and international institutions and organizations to develop the necessary infrastructure and community awareness to conduct vaccine trials in Botswana.
		No HIV vaccine design will be evaluated in large-scale efficacy trials until it had been fully approved for safety, and such designs will be concurrently tried for safety in southern Africa and in the United States.
		The HIV Vaccine Trials Network, which is funded by the United States National Institutes of Health, conducts all phases of clinical trials, from evaluating candidate vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.
	www.hsph.harvard.edu /hai/research/vaccine.html (704 words)

	WJACTV.com - News - Cancer Vaccine Trials
		The research is similar to the ongoing patient study of the breast cancer vaccine.
		Diana is one of nearly two dozen ladies, who is actively involved in the vaccine trial at the Windber Medical Center.
		Or some are of the mindset of it being a clinical trial of being a guinea pig but I don't look at it that way.
	www.wjactv.com /news/3964576/detail.html (592 words)

	HIV vaccine trials yield encouraging results (Site not responding. Last check: 2007-10-26)
		Other novel vaccine strategies are also in the pipeline, including a candidate vaccine that targets a number of HIV-1 clades, projected by investigators at NIAID to enter clinical trials later this fall.
		Two novel vaccines will enter phase I human clinical trials this year under a single protocol in which participants are equally selected and enrolled in the US and Botswana.
		The expectation for an initial HIV vaccine is not for 90% to 100% efficacy, but for a meaningful, clinical, and population-based effect, Dr. Corey explained.
	www.aidsmeds.com /news/20020930drgd009.html (579 words)

	More women and adolescents should be included in HIV vaccine trials (Site not responding. Last check: 2007-10-26)
		Greater participation of women and adolescents is needed in HIV vaccine clinical trials, according to a group of international experts, who attended a consultation on HIV vaccine trials in Lausanne, Switzerland, from 26-28 August.
		More than 30 promising, new candidate HIV vaccines are currently being tested in human clinical trials, the majority of which began in the past four years.
		The international HIV vaccine research mission is to develop HIV vaccines that are licensed, acceptable, available and accessible by all populations regardless of their gender, age, socio-economic status, race, ethnicity or country, and that are effective across the board.
	www.pharma-lexicon.com /medicalnews.php?newsid=12712 (897 words)

	Avian Flu Vaccine Trials Begin in U.S. Medical Centers
		James Campbell is principal investigator for the vaccine trials at the University of Maryland School of Medicine.
		In terms of immune response, Dr. Campbell says, blood is drawn before vaccination and multiple times after vaccination and analyzed in the laboratory to see whether or not volunteers have mounted an immune response.
		Since the vaccine is made with an inactivated or killed avian influenza virus, volunteers are not at risk of contracting the disease.
	www.iwar.org.uk /news-archive/2005/04-07-4.htm (634 words)

	TurnTo10 - NBC 10 Health Check - HIV Vaccine Trials Seek Volunteers (Site not responding. Last check: 2007-10-26)
		Since the HIV Vaccine Trials Network was formed three years ago, the international partnership of research scientists has shifted into full gear.
		Jennifer Demers is a volunteer in one of nine HIV vaccine trials going on at The Miriam Hospital.
		There are HIV vaccine trials going on worldwide -- with the same goal, to find a vaccine to prevent the disease.
	www.turnto10.com /healthcheck10/2628437/detail.html (373 words)

	CIDRAP >> Myopericarditis cases complicate Acambis smallpox vaccine trials
		Apr 13, 2004 (CIDRAP News) –British biotechnology company Acambis plc has temporarily stopped recruiting volunteers for clinical trials of the cell-culture smallpox vaccine it is making for the US government because at least three cases of myopericarditis have occurred in one of the trials.
		The cases occurred in a phase 3 trial in which 1,132 volunteers who had never had a smallpox shot before have been vaccinated with either the Acambis vaccine, called ACAM2000, or Dryvax, the currently licensed smallpox vaccine, the company said in a news release.
		The company's vaccine is grown in cell culture, unlike Dryvax, which was grown on the skin of calves.
	www.cidrap.umn.edu /cidrap/content/bt/smallpox/news/apr1304acambis.html (591 words)

	Human Hookworm Vaccine Initiative Overview (Site not responding. Last check: 2007-10-26)
		The suffering caused by hookworm, is not well known in the developed world, but elsewhere it is another story: hookworm infection is one of the world’s most prevalent infections, afflicting an estimated 740 million people in the developing nations of the tropics.
		This work was done at the Sabin Vaccine Institute laboratories at the Department of Microbiology and Tropical Medicine of The George Washington University.
		The daunting task of developing a vaccine against a complex parasite like hookworm, as well as the observation that hookworm infection strikes only the poorest of the poor in developing countries has discouraged interest from any of the major vaccine manufacturers.
	www.sabin.org /hookworm.htm (608 words)

	Randomized vaccine trials
		Thus, for a trial to be justified, people facing the actual consequences of illness must be uncertain about the preferred approach and want to know which is better.
		After the vaccine is created and administered, an immune stimulant, typically GM-CSF, is also given to the patient to boost immune function and increase the chances of recognition of the target proteins.
		We know that the designers of vaccine trials are aware of the potential negative impact of standard treatments: "End-stage patients without intact immune systems may have very little likelihood of benefit or toxicity from a tumor vaccine.[3]"
	www.lymphomation.org /comparrandomized.htm (2591 words)

	NIP: Vacsafe/Res/Acellular Pertussis: Follow-up Studies (Site not responding. Last check: 2007-10-26)
		Although the clinical trial data presented at this meeting clearly show that the acellular pertussis vaccines as DTaP are safer than the whole-cell pertussis vaccine as DTP, several important questions about the safety of DTaPs remain to be answered.
		Clinical trials, despite their admittedly methodological purity and elegance, are limited in sample size, duration, and population heterogeneity.
		The size of the phase I/II trials (in the hundreds to low thousands) and phase III trials (in the low tens of thousands) for acellular pertussis vaccines in infants are clearly too small to address such an issue.
	www.cdc.gov /nip/vacsafe/research/ap.htm (1040 words)

	Prostate Cancer Vaccine - Clinical Trials (Site not responding. Last check: 2007-10-26)
		These trials were designed to evaluate the safety and efficacy of the immunotherapy, as well as treatment regimens for Phase 3 clinical trials.
		Thirty-four patients were entered in the trial and were assigned to receive either low dose (24 patients) or high dose (10 patients) of the immunotherapy treatment as their only cancer therapy for up to a six-month period.
		The VITAL-1 trial is designed to demonstrate superior survival in the patients receiving GVAX cancer immunotherapy compared to patients receiving Taxotere plus predinsone therapy and is expected to enroll approximately 600 patients.
	www.cellgenesys.com /clinicaltrials-prostate-cancer.shtml (972 words)

	Harvard Public Health Review: AIDS Vaccine Trials Debated
		Much of the current focus is on vaccine trials, with one of the key questions being the standard for antiretroviral therapy for people in the trials who become infected with HIV.
		Thus a vaccine being tested among intravenous drug users in Thailand should be based on the subtype of HIV circulating in that population, which happens to be HIV1-E. "You should test their virus," he insists.
		Vaccine developers may have found a way out of this problem by cleverly manipulating vaccines so they are combinations of a number of different antigen subtypes.
	www.hsph.harvard.edu /review/aids.shtml (1067 words)

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