Ben Shapiro…. what's the end game there>? Mossad?
Scientists Develop Novel Vaccine for Lassa Fever and Rabies
A novel vaccine designed to protect people from both Lassa fever and rabies showed promise in preclinical testing, according to new research published in Nature Communications. The investigational vaccine, called LASSARAB, was developed and tested by scientists at Thomas Jefferson University in Philadelphia; the University of Minho in Braga, Portugal; the University of California, San Diego; and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The inactivated recombinant vaccine candidate uses a weakened rabies virus vector, or carrier. The research team inserted genetic material from Lassa virus into the rabies virus vector so the vaccine expresses surface proteins from both the Lassa virus and the rabies virus. These surface proteins prompt an immune response against both Lassa and rabies viruses. The recombinant vaccine was then inactivated to “kill” the live rabies virus used to make the carrier.
There are currently no approved Lassa fever vaccines. Although Lassa fever is often a mild illness, some people experience serious symptoms, such as hemorrhage (severe bleeding) and shock. The overall Lassa virus infection case-fatality rate is about one percent, according to the World Health Organization (WHO), but that rate rises to 15 percent for patients hospitalized with severe cases of Lassa fever. People contract Lassa virus through contact with infected Mastomys rats and through exposure to an infected person’s bodily fluids. Lassa fever is endemic to West Africa where these rats are common. In 2018, Nigeria experienced its largest-ever Lassa fever outbreak, with 514 confirmed cases and 134 deaths from Jan. 1 through Sept. 30, according to the Nigeria Centre for Disease Control (link is external).
Africa is also at high risk for human rabies. The WHO estimates that 95 percent of the estimated 59,000 human rabies deaths per year occur in Africa and Asia (link is external). Nearly all human rabies deaths are caused by bites or scratches from infected dogs. Effective rabies vaccines and post-exposure shots are available, but many deaths still occur in resource-limited countries (link is external), according to the CDC.
The newly published findings show that LASSARAB, when administered with GLA-SE adjuvant (an immune response-stimulating protein), elicits antibodies against Lassa virus and rabies virus in mouse and guinea pig models. The vaccine also protected guinea pigs from Lassa fever after being exposed to the virus 58 days after vaccination.
Prior research indicated that an antibody-mediated immune response is not correlated with protection from Lassa fever, the authors note. However, the new findings show that high levels of non-neutralizing immunoglobulin G (IgG) antibodies that bind to the Lassa virus surface protein correlate with protection against Lassa virus. Levels of this type of antibody could potentially be a Lassa fever correlate of protection used to determine vaccine efficacy, according to the authors. They note the next step is to evaluate the experimental vaccine in nonhuman primates before advancing to human clinical trials.
ARTICLE:
T Abreu-Mota et al. Non-neutralizing antibodies elicited by recombinant Lassa-Rabies vaccine are critical for protection against Lassa fever. Nature Communications DOI: 10.1038/s41467-018-06741-w (2018).
WHO:
Reed Johnson, Ph.D., staff scientist in the Emerging Viral Pathogens Section part of NIAID’s Laboratory of Immunoregulation, is available for comment.
Content last reviewed on October 11, 2018
https://www.niaid.nih.gov/news-events/scientists-develop-novel-vaccine-lassa-fever-and-rabies
Experimental Nasal Influenza Vaccine Tested in Kids, Teens
NIAID-Supported Phase 1 Trial of Potential Broadly Protective Vaccine
September 17, 2018
An early-stage clinical trial testing the safety and immune-stimulating ability of an experimental nasal influenza vaccine in healthy 9- to 17-year-old children and teens has begun enrolling participants at a Vaccine and Treatment Evaluation Unit (VTEU) site at Saint Louis University, St. Louis, Missouri. The VTEU is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Annual vaccination against influenza is recommended for everyone over six months of age. However, because the flu virus changes from year to year, vaccines must be reformulated annually to take account of those changes. When mismatches occur, vaccine effectiveness may suffer. “We are hopeful that newer kinds of influenza vaccines, such as the candidate being tested in this trial, will provide protection even if their components do not precisely match the currently circulating influenza virus strains,” said NIAID Director Anthony S. Fauci, M.D.
Principal investigator Daniel Hoft, M.D., Ph.D., leads the clinical trial, which will enroll 50 participants. Half will receive the candidate nasal vaccine and the other half will receive a dose of inactive saline solution delivered as nasal spray. Neither the study staff nor volunteers will know whether a participant has received the experimental vaccine or placebo saline solution. All volunteers will receive an intramuscular injection of a licensed, quadrivalent seasonal influenza vaccine three months after receiving the initial nasal vaccine or placebo. An important objective of the study is to determine whether the combination of the licensed and experimental vaccine leads to broader protection against influenza viruses compared with the licensed vaccine alone. Investigators will perform an array of tests on volunteer blood samples at four time points following the first vaccination as well as three weeks after the second vaccination. They will look for evidence of immune responses from antibody-producing cells as well as from the cellular arm of the immune system.
The investigational vaccine, developed by FluGen, Inc. of Madison, Wisconsin, is made from a strain of seasonal influenza virus (H3N2) that has been genetically designed to replicate only once in the body. Studies in animals showed that the “single replication” virus does not cause disease but nevertheless prompted a robust immune response akin to that of a natural influenza infection. Investigators hypothesize that volunteers who receive the candidate vaccine will have a robust immune response not only against H3N2 strains that match those in the vaccine but also against influenza strains that are mismatched to the vaccine strain. A previous Phase 1 trial of this candidate vaccine in healthy adults showed that it was safe and generated a robust immune response and a Phase 2 trial in healthy adults is currently underway (that trial is not supported by NIAID.)
For more information about this trial of an experimental influenza vaccine in older children and adolescents, visit ClinicalTrials.gov (link is external) and search on identifier NCT03553940 (link is external). The VTEUs are funded by NIAID through contract number HHSN272201300021.
Content last reviewed on September 17, 2018
https://www.niaid.nih.gov/news-events/experimental-nasal-influenza-vaccine-tested-kids-teens
Vaccinations have begun in a first-in-human trial of an experimental live, attenuated Zika virus vaccine developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial will enroll a total of 28 healthy, non-pregnant adults ages 18 to 50 at the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, Maryland, and at the Vaccine Testing Center at the Larner College of Medicine at the University of Vermont in Burlington. NIAID is sponsoring the trial.
Although most people experience a mild illness or no symptoms when infected with Zika virus, babies born to women infected with Zika virus during pregnancy may have birth defects and/or develop health problems in their early years.
Zika virus is primarily transmitted to humans by the bite of an infected mosquito or can be transmitted through sex. As a result, the Centers for Disease Control and Prevention (CDC) advises that pregnant women should not travel to areas with risk of Zika (link is external). CDC also recommends that partners of pregnant women and couples considering pregnancy should know pregnancy risks and take certain precautions (link is external). The U.S. Zika Pregnancy and Infant Registry (link is external) has recorded the number of pregnant women with laboratory evidence of possible Zika virus infection since 2015. As of July 17, 2018, the registry had recorded 2474 pregnancies in states and the District of Columbia and 4900 pregnancies in U.S. territories and freely associated states.
“Zika virus infection remains a significant threat to pregnant women and their developing fetuses, and we can expect to see periodic outbreaks and cases in areas where Aedes aegypti mosquitoes thrive,” said NIAID Director Anthony S. Fauci, M.D. “NIAID remains committed to developing safe and effective Zika vaccines, and we are pleased to begin clinical testing of a live attenuated candidate.” No licensed vaccines for Zika virus infection are currently available; however, several are in various stages of development.
Stephen Whitehead, Ph.D., of NIAID’s Laboratory of Viral Diseases, led the efforts to develop the experimental vaccine, known as rZIKV/D4Δ30-713. The laboratory used genetic engineering techniques to create a chimeric virus, made by combining genes from multiple viruses. The chimeric virus consists of a dengue virus type 4 backbone (dengue is caused by any of four related viruses, termed serotypes) that expresses Zika virus surface proteins. The chimeric virus is live but attenuated, or weakened, so it cannot cause disease in recipients. When injected into the body, the weakened virus should prompt an immune response. The Phase 1 clinical trial will analyze this response in participants and assess the safety of the experimental vaccine, which showed promise in earlier tests in rhesus macaques (monkeys). Charles River Laboratories, in Malvern Pennsylvania, manufactured the vaccine candidate for the Phase 1 clinical trial.
Dr. Whitehead also has developed a live, attenuated dengue vaccine candidate called TV003 designed to elicit antibodies against all four dengue virus serotypes. The experimental vaccine is currently under evaluation in a Phase 3 clinical trial conducted in Brazil by the Butantan Institute. Dr. Whitehead plans to develop a single vaccine that would protect against both Zika and dengue viruses. According to the CDC, dengue is endemic in at least 100 countries in Asia, the Pacific, the Americas, Africa and the Caribbean. Zika virus has been found to circulate in many of these same areas. Once the Zika vaccine candidate proves safe in Phase 1 clinical testing, Dr. Whitehead plans to add the Zika component to the tetravalent dengue vaccine candidate and evaluate the new pentavalent candidate in a Phase 1 clinical trial.
Anna Durbin, M.D., professor of International Health at the Johns Hopkins Bloomberg School of Public Health and part of the university’s Center for Immunization Research, is leading the Phase 1 clinical trial of the monovalent Zika vaccine candidate. Kristen Pierce, M.D., associate professor at the Larner College of Medicine at the University of Vermont, is a co-investigator.
Interested volunteers who test positive for a prior flavivirus infection (such as Zika, dengue, or yellow fever) will be excluded from the trial to ensure that any antibodies detected in blood samples are related to the experimental vaccine alone. All participants will be randomly assigned to receive a single subcutaneous dose of the experimental vaccine (20 participants) or a placebo (eight participants). Neither the participants nor the investigators will know who is receiving the experimental vaccine….
Content last reviewed on August 16, 2018
https://www.niaid.nih.gov/news-events/nih-begins-clinical-trial-live-attenuated-zika-vaccine
military uses rare vaccines
Early-Stage Respiratory Syncytial Virus (RSV) Vaccine Trial Begins
June 14, 2018
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has launched a clinical trial of an investigational vaccine designed to protect against respiratory syncytial virus (RSV). The Phase 1 study will enroll a small group of healthy adult volunteers to examine the safety of an experimental intranasal vaccine and its ability to induce an immune response. The study is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs).
RSV, a common virus, typically causes mild, cold-like symptoms that resolve within two weeks. However, the virus can cause severe symptoms, especially among infants and young children. Each year, an estimated 57,000 children under the age of five years are hospitalized in the United States due to RSV infection, according to the Centers for Disease Control and Prevention (CDC). Globally, RSV is estimated to cause up to 200,000 deaths annually, according to the World Health Organization. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia among children under the age of 1 year. Almost all children in the United States are infected with RSV at least once by the age of 2, and most will experience repeated infections over their lifetimes.
Additionally, people 65 years or older, adults with chronic heart or lung disease, and individuals with weakened immune systems are at increased risk of severe RSV infection. Each year in the United States, RSV leads to an average of 14,000 deaths among adults older than 65 years, according to the CDC. Currently, no specific treatments or vaccines are available for RSV.
“RSV infection is a significant cause of illness and disease among the most vulnerable populations,” said NIAID Director Anthony S. Fauci, M.D. “A vaccine to prevent disease from this pervasive and sometimes deadly virus is urgently needed.”
Led by principal investigator David Bernstein, M.D., of the Cincinnati Children’s Hospital Medical Center, the study is testing an experimental vaccine called SeVRSV. The vaccine candidate was developed by researchers at St. Jude Children’s Research Hospital and manufactured by Children’s GMP LLC, of St. Jude Children’s Research Hospital in Memphis, Tennessee. SeVRSV contains a modified mouse virus (Sendai virus) designed to carry RSV genetic material that will express RSV fusion protein in the vaccine recipient to stimulate RSV-specific antibodies and T-cells. The Sendai virus vaccine platform has been well-tolerated to date in human clinical trials of vaccines for other infectious diseases, including HIV. SeVRSV performed well in previous preclinical and animal studies.
The study will enroll up to 25 healthy, non-pregnant volunteers between 18 and 45 years. After receiving an initial screening exam, at least 16 volunteers will be given a single intranasal dose of the experimental vaccine (0.22 milliliters in each nostril) and four or more will receive a placebo, in the form of saline nose drops. After vaccination, all volunteers will be observed for at least 30 minutes.
Afterwards, volunteers will report for five clinic visits over 29 days. During these visits, volunteers will be examined for any adverse reactions, and blood samples and nasal washes will be collected to check for RSV-specific antibodies. The volunteers will return at two and six months after vaccination.
For more information about this trial, visit ClinicalTrials.gov (link is external) and search identifier NCT03473002 (link is external).
Content last reviewed on June 14, 2018
https://www.niaid.nih.gov/news-events/early-stage-respiratory-syncytial-virus-rsv-vaccine-trial-begins
let me ask u this anon
I am really concerned and people about vaccines in general not to the extreme others take it to…. why would the Trump admin at this point let this continue? and if its in clinical trial that's the point right test without hurting much…
I think so i really ask genuinely
I will put some vaccine info out there, please help me find truth in this… how can we let so many babies be getting hurt everyday but stop the rape…. doesn't make sense… unless slower process… and slowly info come out about it… but then again WHY LET IT CONTINUE IF IN FULL CONTROL
small pox etc
small pox, etc already made yellow fever