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    Vaccine Trials

    BIOTERRORBIBLE.COM: If and when a full-scale bio-terror attack occurs, the live pathogens or agents responsible for the pandemic will likely be dispersed via A) chemtrails by government airplanes and/or drones, B) by the U.S. Postal Service via Tide detergent samples, C) by the government and medical establishment via tainted vaccines, or by D) the portable petri dish commonly known as the Trojan condom.

    A wealth of recent medical research indicates that
    vaccines are no longer safe and may cause serious neurological problems, seizures, autism and even death. A recent push by the medical and government establishment in America to make vaccines mandatory may go into effect after a pandemic in which martial military law will be called and personal freedoms like the right to refuse a vaccine will be denied.


    In a major bio-terror related pandemic, it will be the tainted vaccines which are ultimately responsible for killing 99% of the victims.

    Title: NIAID Launches Malaria Vaccine Trial In Africa
    Date: September 11, 2003
    Source: Sciece Daily

    Abstract:
      The National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, has reached a milestone in its efforts to support accelerated development of malaria vaccines. Working with an international group of public and private partners, NIAID has launched its first trial of a candidate malaria vaccine in a country where malaria is endemic. The Phase I trial, taking place in Mali, seeks to confirm the safety and immunogenicity in adults of a candidate vaccine called FMP-1.

    A key component of the NIAID Plan for Research for Malaria Vaccine Development has been to establish, in malaria-endemic areas, research centers that can support the complex clinical development of malaria vaccines. Conducting a malaria vaccine trial in Africa is important because more than 90 percent of malaria deaths occur in Africa, and the great majority of these deaths are in young children. Each year, malaria infects an estimated 300 to 500 million people worldwide and causes more than 1 million deaths, according to the World Health Organization.

    This trial, the first to be conducted by Malian researchers from the Malaria Research and Training Center in the Department of Epidemiology of Parasitic Diseases at the Medical School of the University of Bamako, is taking place in Bandiagara, Mali, with NIAID support. It reflects the result of many years of effort by a group of organizations dedicated to creating an effective malaria vaccine. In addition to NIAID and the University of Bamako, the collaborators include the University of Maryland at Baltimore; NIAID's Malaria Vaccine Development Unit; the Malian Ministries of Health and Education; the Walter Reed Army Institute of Research (WRAIR); GlaxoSmithKline Biologicals (GSK); the U.S. Agency for International Development (USAID); and the World Health Organization (WHO).

    Developed by WRAIR in collaboration with GSK Biologicals, and with support from USAID, the FMP-1 vaccine has already proved safe and immunogenic in two small Phase I and Phase IIa studies in the United States and an additional Phase I study in Kenya. The vaccine contains an experimental adjuvant called AS02A developed by GSK and intended to enhance the immune response.

    The trial will enroll 40 adults between the ages of 18 and 55. Half of the volunteers will receive the malaria vaccine and half will serve as a control group by receiving a licensed rabies vaccine. Each volunteer will receive three injections over two months, and the researchers will follow each volunteer for one year, monitoring the long-term safety of the vaccine and analyzing the immune responses against the Plasmodium falciparum malaria parasite (Sciece Daily, 2003).

    Title: U.S. Disease Researchers Begin Ebola Vaccine Trial
    Date: November 24, 2003
    Source: Scoop News

    Abstract: Trial begins as new disease outbreak occurs in Republic of the Congo

    A trial of the first experimental vaccine to prevent infection from the deadly Ebola virus began November 18 at the National Institute for Allergies and Infectious Diseases (NIAID) in Bethesda, Maryland.

    The vaccine contains no infectious material from the Ebola virus, but was synthesized using modified, inactivated genes from the pathogen. According to a NIAID press release, 27 volunteers will be participating in the one-year trial in which researchers will seek to ascertain the safety of the vaccine.

    The vaccine trial begins as the World Health Organization reported the occurrence of 11 cases of Ebola appearing in the Republic of the Congo November 17. Previous outbreaks in Africa have killed up to 90 percent of those infected. Considered one of the most deadly diseases known to medical science, Ebola' symptoms are a sudden onset of fever, weakness, muscle pain, headache and sore throat. This is followed by vomiting, diarrhea, rash, limited kidney and liver functions, and both internal and external bleeding.

    "An effective Ebola vaccine not only would provide a life-saving advance in countries where the disease occurs naturally, it also would provide a medical tool to discourage the use of Ebola virus as an agent of bioterrorism," said NIAID Director Anthony S. Fauci, M.D.

    Following is the text of the NIAID press release:

    (begin text)

    National Institute of Allergy and Infectious Diseases
    National Institutes of Health

    Nov. 18, 2003

    NIAID EBOLA VACCINE ENTERS HUMAN TRIAL

    The first human trial of a vaccine designed to prevent Ebola infection opened today. Scientists from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health (NIH), designed the vaccine, which was administered to a volunteer at the NIH Clinical Center in Bethesda. The vaccine does not contain any infectious material from the Ebola virus.

    Just three years ago, VRC Director Gary Nabel, M.D., Ph.D., together with a team of scientists from the VRC and the Centers for Disease Control and Prevention, described an experimental Ebola vaccine that fully protected monkeys from lethal infection by the virus. One component of that vaccine will now be assessed for safety in human volunteers. The trial vaccine, a type called a DNA vaccine, is similar to other investigational vaccines that hold promise for controlling such diseases as AIDS, influenza, malaria and hepatitis.

    "This trial is further evidence of the ability of the VRC to rapidly translate basic research into tangible products," notes NIAID Director Anthony S. Fauci, M.D. "Our accelerated effort to understand and combat Ebola infection is part of the NIAID commitment to its biodefense mission. An effective Ebola vaccine not only would provide a life-saving advance in countries where the disease occurs naturally, it also would provide a medical tool to discourage the use of Ebola virus as an agent of bioterrorism."

    Outbreaks of Ebola in Africa kill up to 90 percent of those infected. No effective treatment exists for this highly infectious disease, which causes extensive internal bleeding and rapid death. According to experts, vaccination is the best strategy for preventing or containing this deadly infection.

    A gap of two decades separated the first Ebola epidemic of 1976 and the next, which arose in 1995. In recent years, for reasons unknown, outbreaks of Ebola are occurring with increasing frequency.

    On November 17, 2003, the World Health Organization reported 11 cases of Ebola hemorrhagic fever in the Republic of the Congo. Dr. Nabel notes, "The current Ebola outbreak in the Congo provides a stark reminder of the need to rapidly develop vaccines against such perilous infections. A few years ago, we did not imagine that our vaccine would enter human trials so quickly, but the re-emergence of such viruses makes it all the more important to respond quickly. Individuals who volunteer for these vaccine trials can help us understand if our new vaccines ultimately will be effective."

    Twenty-seven volunteers between the ages of 18 and 44 will participate in the study. Six people will receive a placebo injection and 21 will receive the investigational vaccine, manufactured by Vical Inc., a San Diego biotechnology company working in collaboration with the VRC. Vical has also secured a nonexclusive license from NIH to proprietary gene sequences used in the DNA Ebola vaccine. In the new trial, volunteers will receive three injections over two months and will be followed for one year. Volunteers will not be exposed to Ebola virus. Individuals interested in enrolling in the trial may visit http://www.clinicaltrials.gov or call the VRC toll-free at 1-866-833-LIFE (5433).

    The candidate vaccine is synthesized using modified, inactivated genes from Ebola virus. This gives the immune system information about viral structures so that it can mount a rapid defense should the real virus ever be encountered. There is no infectious material in the vaccine, and the virus was not present during any stage of the manufacturing process, notes Barney Graham, M.D., Ph.D., director of the clinical trials unit of the VRC. "It is impossible for the vaccine to cause infection," he adds, "because it employs new technology known to safely stimulate broad immune responses."

    Besides assessing the vaccine's safety, researchers will also examine the volunteers' blood to look for signs of immune system reaction to the vaccine. Ultimately, the scientists envision this vaccine as the first in a two-stage vaccination strategy called prime-boost: after "priming" with the DNA vaccine, the immune system response is "boosted," or augmented, by a second inoculation with modified, non-disease-causing cold viruses that make selected Ebola proteins. The booster essentially sets the immune system on alert against future infection by Ebola virus.

    In August, Dr. Nabel and his colleagues reported using the booster shot to quickly and completely protect monkeys against Ebola. A fast-acting vaccine would be of great use during an outbreak of Ebola. The full prime-boost strategy, which uses the DNA vaccine being tested in this study, elicits a stronger immune response and is important to pursue for individuals at high risk, such as health care workers. Dr. Nabel says that expanded human trials of Ebola vaccines using the prime-boost strategy could begin by 2005.

    NIAID is a component of the National Institutes of Health (NIH), which is an agency of the Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies (Scoop News, 2003).

    TItle: Vaccine Candidate Against Lassa Fever 'Shows Promise'
    Date: June 18, 2005
    Source: SciDev

    Abstract: Researchers have developed a new candidate vaccine against Lassa fever, a disease related to Ebola and Marburg, which infects 200,000 people in West Africa each year.

    There is currently no vaccine against the disease.

    Previous promising candidates were shown to be unsuitable for use in areas where HIV/AIDS is common, as they could cause serious skin lesions.

    Thomas Geisberg, of the US Army Medical Research Institute of infectious Diseases, and his colleagues describe the potential new vaccine this week in PLoS Medicine.

    To make their vaccine, the researchers used a virus that causes a skin disease in cattle. They weakened this virus so that it would not cause the disease, then altered it to produce a Lassa virus protein.

    In this way, the team was able to create a harmless virus that would still expose those who received it to a key component of the Lassa virus, allowing recipients' immune systems to develop protection against it.

    The researchers gave the test vaccine to four macaque monkeys, then exposed them to live Lassa virus.

    Although the monkeys initially showed signs of the virus replicating in their blood, they were entirely protected within ten days of being exposed to it. 

    Two 'control' monkeys were given the weakened cattle virus without any Lassa virus protein, then exposed to Lassa virus. Blood tests showed that Lassa virus continued to replicate in these monkeys.

    Although it is early days, the results are significant because of the lack, until recently, of funds for research into Lassa fever.

    The disease occurs mostly in West Africa — in Guinea, Liberia, Nigeria, and Sierra Leone — where it is thought to infect more than 200,000 people each year, many more than other related viruses, including Ebola and Marburg, do.

    But recently the virus has been imported to the United States and Europe. This, combined with concerns about bioterrorism, has brought new funds to research into the disease.

    The virus causes no or mild symptoms in 80 per cent of infected patients, but 20 per cent get very ill and one to two per cent die from it.

    Pregnant women are particularly at risk. Nearly all children die in the womb if their mother becomes infected (SciDev, 2005). 

    Title: Experimental Vaccine Protects Nonhuman Primates When Given After Exposure To Marburg Virus
    Date:
    April 27, 2006
    Source: Science Daily

    Abstract:
    A team of U.S. and Canadian scientists has demonstrated the effectiveness of a vaccine in preventing the development of hemorrhagic fever in an animal model after exposure to the deadly Marburg virus. Their findings, published in the April 27 online edition of the British medical journal The Lancet, could have implications for human use.

    Marburg virus was first detected in 1967 and was the cause of a large outbreak in Angola in 2004-2005 that resulted in several hundred deaths with case fatality rates of about 90 percent. Like the Ebola virus, Marburg is a filovirus that causes internal bleeding at multiple sites with patients usually dying as a result of multiple organ failure. Both viruses are considered to be potential agents of bioterrorism. Currently, no effective vaccines or drugs against Marburg virus exist, and treatment of the disease is limited to supportive care.

    Investigators from the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the National Microbiology Laboratory at the Public Health Agency of Canada (PHAC) created the vaccine against Marburg virus by replacing a gene from a harmless virus--known as vesicular stomatitis virus, or VSV--with a gene encoding a Marburg virus surface protein.

    The team infected five rhesus monkeys with the Marburg virus and then injected them with the vaccine (known as recombinant VSV, or rVSV) 20 to 30 minutes later.

    Another three monkeys infected with Marburg virus acted as controls and received a vaccine without the Marburg protein.

    All of the monkeys treated with rVSV following exposure to the Marburg virus survived for at least 80 days, while the controls succumbed to the disease by day 12.

    In a study published in June 2005, the research team reported that the rVSV vaccine could prevent Marburg hemorrhagic fever from developing when administered before infection. The new results suggest that the vaccine could also be an effective post-exposure treatment for the disease.

    "These results are very encouraging, as this is the first demonstration of complete post-exposure protection of nonhuman primates against a filovirus," said Thomas W. Geisbert, one of the USAMRIID investigators.

    Colonel George W. Korch, Jr., commander of the Institute, added, "This outstanding collaboration has been instrumental in producing novel breakthroughs, such as this, for discovery of medical approaches for difficult public health and biodefense problems."

    PHAC's National Microbiology Laboratory is Canada's only Containment Level 4 laboratory, where pathogens such as Ebola and Marburg can be worked with safely. The Winnipeg-based laboratory has been at the forefront of research into SARS, West Nile virus, anthrax and other dangerous pathogens.

    USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command (Science Daily, 2006).

    Title: Homeless People Die After Bird Flu Vaccine Trial In Poland
    Date: July 2, 2008
    Source: Telegraph

    Abstract: Three Polish doctors and six nurses are facing criminal prosecution after a number of homeless people died following medical trials for a vaccine to the H5N1 bird-flu virus.

    The medical staff, from the northern town of Grudziadz, are being investigated over medical trials on as many as 350 homeless and poor people last year, which prosecutors say involved an untried vaccine to the highly-contagious virus.

    Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

    The director of a Grudziadz homeless centre, Mieczyslaw Waclawski, told a Polish newspaper that last year, 21 people from his centre died, a figure well above the average of about eight.

    Although authorities have yet to prove a direct link between the deaths and the activities of the medical staff, Poland's health minister, Ewa Kopacz, has said that the doctors and nurses involved should not return to their profession.

    "It is in the interests of all doctors that those who are responsible for this are punished," the minister added.

    Investigators are also probing the possibility that the medical staff may have also have deceived the pharmaceutical companies that commissioned the trials.

    The suspects said that the all those involved knew that the trial involved an anti-H5N1 drug and willingly participated.

    The news of the investigation will come as another blow to the reputation of Poland's beleaguered and poverty-stricken national health service. In 2002, a number of ambulance medics were found guilty of killing their patients for commissions from funeral companies (Telegraph, 2008).

    Title: Uganda To Conduct Marburg Vaccine Trials
    Date: October 8, 2009
    Source: All Africa

    Abstract: UGANDA could hold the key to the Ebola and Marburg vaccines as the country has been selected for a high profile second stage safety trial in humans.

    Dr. Hannah Kibuuka, the director clinical programmes at the Makerere University Walter Reed project, who is conducting the experiments, said the trial comes after a smaller one in the US (All Africa, 2009).

    Title: Canadian Doctors Ready To Test Ebola Vaccine On Humans
    Date: May 8, 2012
    Source: BioPrepWatch


    Abstract: Canadian doctors recently announced they are preparing to conduct human clinical trials on a new vaccine against the Ebola virus.

    Researchers from Winnipeg’s National Microbiology Laboratory said they will hold talks with Health Canada next month about conducting human studies on a vaccine that has been shown to cure animal subjects within 24 hours after exposure, according to TheGlobeandMail.com.

    “Ebola is still the most dangerous and virulent infectious agent out there,” Dr. Kobinger, the project’s leader, said, TheGlobeandMail.com reports. “You take the biggest and the toughest and you try to bring it down, with the rationale that if it works against Ebola, it’ll work against other things.”

    Kobinger grew up in Quebec City in the early 1990s and vividly remembers being inspired by the beginnings of the fight against HIV/AIDS. He has been chasing vaccines ever since.

    “In my mind, as a teenager, this was unacceptable,” Kobinger said, according to TheGlobeandMail.com. “So I decided this was where I would put my energy.”

    Dr. Gary Nabel, the director of the U.S. National Institutes of Health’s vaccine research center, said he is somewhat skeptical of the claims behind the Canadian vaccine, but said it is critical to find an effective treatment for the virus.

    “This is high on the radar screen for bio-defense. It’s transmitted human-to-human; it’s high-mortality; it’s been weaponized,” Nabel said, TheGlobeandMail.com reports. “It’s the threat that it could pose if it got into the wrong place that is the concern” (BioPrepWatch, 2012)

    Title: Experimental Malaria Shot A Letdown; Only Reduces Cases By 30 Percent In Infants
    Date:
    November 9, 2012
    Source:
    Fox News

    Abstract:
    An experimental malaria vaccine once thought promising is turning out to be a disappointment, with a new study showing it is only about 30 percent effective at protecting infants from the killer disease.

    That is a significant drop from a study last year done in slightly older children, which suggested the vaccine cut the malaria risk by about half — though that is still far below the protection provided from most vaccines. According to details released on Friday, the three-shot regimen reduced malaria cases by about 30 percent in infants aged 6 to 12 weeks, the target age for immunization.

    Dr. Jennifer Cohn, a medical coordinator at Doctors Without Borders, described the vaccine's protection levels as "unacceptably low." She was not linked to the study.

    Scientists have been working for decades to develop a malaria vaccine, a complicated endeavor since the disease is caused by five different species of parasites. There has never been an effective vaccine against a parasite. Worldwide, there are several dozen malaria vaccine candidates being researched.

    In 2006, a group of experts led by the World Health Organization said a malaria vaccine should cut the risk of severe disease and death by at least half and should last longer than one year. Malaria is spread by mosquitoes and kills more than 650,000 people every year, mostly young children and pregnant women in Africa. Without a vaccine, officials have focused on distributing insecticide-treated bed nets, spraying homes with pesticides and ensuring access to good medicines.

    In the new study, scientists found babies who got three doses of the vaccine had about 30 percent fewer cases of malaria than those who didn't get immunized. The research included more than 6,500 infants in Africa. Experts also found the vaccine reduced the amount of severe malaria by about 26 percent, up to 14 months after the babies were immunized.

    Scientists said they needed to analyze the data further to understand why the vaccine may be working differently in different regions. For example, babies born in areas with high levels of malaria might inherit some antibodies from their mothers which could interfere with any vaccination.

    "Maybe we should be thinking of a first-generation vaccine that is targeted only for certain children," said Dr. Salim Abdulla of the Ifakara Health Institute in Tanzania, one of the study investigators.

    Results were presented at a conference in South Africa on Friday and released online by the New England Journal of Medicine. The study is scheduled to continue until 2014 and is being paid for by GlaxoSmithKline and the PATH Malaria Vaccine Initiative.

    "The results look bad now, but they will probably be worse later," said Adrian Hill of Oxford University, who is developing a competing malaria vaccine. He noted the study showed the Glaxo vaccine lost its potency after several months. Hill said the vaccine might be a hard sell, compared to other vaccines like those for meningitis and pneumococcal disease — which are both effective and cheap.

    "If it turns out to have a clear 30 percent efficacy, it is probably not worth it to implement this in Africa on a large scale," said Genton Blaise, a malaria expert at the Swiss Tropical and Public Health Institute in Basel, who also sits on a WHO advisory board.

    Eleanor Riley of the London School of Hygiene and Tropical Medicine, said the vaccine might be useful if used together with other strategies, like bed nets. She was involved in an earlier study of the vaccine and had hoped for better results. "We're all a bit frustrated that it has proven so hard to make a malaria vaccine," she said. "The question is how much money are the funders willing to keep throwing at it."

    Glaxo first developed the vaccine in 1987 and has invested $300 million in it so far.

    WHO said it couldn't comment on the incomplete results and would wait until the trial was finished before drawing any conclusions (Fox News, 2012).