Independent Monitoring Board Recommends Early Termination of Ebola Therapeutics Trial in DRC Because of Favorable Results with Two of Four Candidates
August 12, 2019
The Pamoja Tulinde Maisha (PALM [together save lives]) study is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018 in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces.
March 06, 2019
Survivors of Ebola virus disease (EVD) in Liberia had a higher prevalence of certain health issues—including uveitis (eye redness and pain), abdominal, chest, neurologic, and musculoskeletal abnormalities upon physical exam—when compared to a control group of household and community members who did not have a history of EVD, according to findings from an ongoing study published in the New England Journal of Medicine. However, even participants in the control group experienced a relatively high burden of health issues overall.
January 24, 2019
The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of NIH, developed the investigational treatment and conducted and sponsored the clinical trial.
November 27, 2018
An international research team has begun patient enrollment in a clinical trial testing multiple investigational Ebola therapies in the Democratic Republic of the Congo (DRC). The randomized, controlled trial is enrolling patients of any age with confirmed Ebola virus disease (EVD) at a treatment unit in the city of Beni operated by The Alliance for International Medical Action (ALIMA), a medical humanitarian organization.
August 28, 2018
Since the first cases of AIDS were reported in the United States 37 years ago, the National Institutes of Health has invested more than $69 billion in the understanding, treatment and prevention of HIV/AIDS. Beyond the development of life-saving medications and innovative prevention modalities, such research has led to numerous advances outside the HIV field, according to a new commentary from experts at NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
August 22, 2018
The Central Africa region is experiencing rapid urbanization and economic growth, and infrastructure development. These changes, while generally positive and welcome, also make the region more vulnerable to explosive infectious disease outbreaks, according to an international group of scientists.
August 10, 2018
Despite promising advances, important scientific questions remain unanswered in the effort to develop a safe and effective Ebola vaccine, according to members of an international Ebola research consortium. In a Viewpoint published in The Lancet, the experts review the current field of Ebola vaccine candidates and clinical trials and highlight key gaps in knowledge that need to be addressed by future research.
July 17, 2018
Recent Ebola virus disease (EVD) outbreaks, including the 2013-2016 epidemic that ravaged West Africa and the 2018 outbreak in the Democratic Republic of the Congo, highlight the need for licensed treatments for this often-deadly disease. ZMapp, an experimental therapy comprising three monoclonal antibodies, has shown promise in a clinical trial, but it targets only one of the five known species of Ebola virus.
May 23, 2018
A first-in-human trial evaluating an experimental treatment for Ebola virus disease has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland. The Phase 1 clinical trial is examining the safety and tolerability of a single monoclonal antibody called mAb114, which was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and their collaborators. Investigators aim to enroll between 18 and 30 healthy volunteers aged 18 to 60. The trial will not expose participants to Ebola virus.
May 08, 2018
Early during the recent Ebola epidemic in West Africa, scientists speculated that the genetic diversity of the circulating Makona strain of virus (EBOV-Makona) would result in more severe disease and more transmissibility than prior strains. However, using two different animal models, National Institutes of Health scientists have determined that certain mutations stabilized early during the epidemic and did not alter Ebola disease presentation or outcome.
March 22, 2018
Novel vaccine technologies are critical to improving the public health response to infectious disease threats that continually emerge and re-emerge, according to scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. In a perspective in The Journal of the American Medical Association, the experts highlight innovations that could significantly shorten the typical decades-long vaccine development timeline.
March 08, 2018
Monoclonal antibodies (mAbs)—preparations of a specific type of antibody designed to bind to a single target—have shown promise in the fight against cancer and autoimmune diseases. They also may play a critical role in future battles against emerging infectious disease outbreaks, according to a new article by scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
February 08, 2018
Ebola virus can infect the reproductive organs of male and female macaques, according to a study published in The American Journal of Pathology, suggesting that humans could be similarly infected. Prior studies of survivors of the 2014-2016 Ebola outbreak in West Africa have revealed sexual transmission of Ebola virus, and that viral RNA (Ebola virus genetic material) can persist in semen following recovery.
October 17, 2017
Scientists and clinicians from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the California Institute of Technology discuss key considerations for developing a universal influenza vaccine in a meeting report appearing in the October 17 issue of Immunity. The report summarizes discussions from a workshop NIAID held June 28-29, 2017, in Rockville, Maryland, entitled, “Pathway to a Universal Influenza Vaccine.” The workshop brought together U.S.
October 11, 2017
Results from a large randomized, placebo-controlled clinical trial in Liberia show that two candidate Ebola vaccines pose no major safety concerns and can elicit immune responses by one month after initial vaccination that last for at least one year. The findings, published in the October 12 issue of the New England Journal of Medicine, are based on a study of 1,500 adults that began during the West Africa Ebola outbreak.
October 04, 2017
Preparedness in the face of major disease outbreaks can save thousands of lives: Rapid deployment of effective diagnostics, treatments, and vaccines may even stop the disease from potentially exploding into a pandemic. A new article by Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and colleagues examines the multifaceted nature of effective preparedness and the particular role that biomedical research plays.
May 18, 2017
The fight to contain the 2013-16 Ebola outbreak in West Africa was hampered by the lack of an effective treatment or vaccine. Researchers funded in part by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have studied the blood of an Ebola survivor, searching for human antibodies that might effectively treat not only people infected with Ebola virus, but those infected with related viruses as well. Now the researchers have identified two such antibodies that hold promise as Ebola treatments.
April 12, 2017
Analysis of daily gene activation in a patient with severe Ebola virus disease cared for at the National Institutes of Health (NIH) in 2015 found changes in antiviral and immune response genes that pinpointed key transition points in the response to infection. The changes included a marked decline in antiviral responses that correlated with clearance of virus from white blood cells. The analysis also showed that the preponderance of host responses shifted rapidly from activation of genes involved in cell damage and inflammation toward those linked to promotion of cellular and organ repair.
April 06, 2017
The French National Institute of Health and Medical Research (Inserm), the US National Institutes of Health (NIH) and the London School of Hygiene & Tropical Medicine (LSHTM), in collaboration with health authorities in Guinea and Liberia, are launching a large clinical trial of candidate Ebola vaccines under the aegis of the PREVAC international consortium (Partnership for Research on Ebola VACcination).
April 05, 2017
Scientists funded by the National Institutes of Health have found that an experimental treatment cured 100 percent of guinea pigs and rhesus monkeys in late stages of infection with lethal levels of Marburg and Ravn viruses, relatives of the Ebola virus. Although the Marburg and Ravn viruses are less familiar than Ebola virus, both can resemble Ebola in symptoms and outcomes in people, and both lack preventive and therapeutic countermeasures.
March 14, 2017
A two-vaccine regimen intended to protect against Ebola virus disease induced an immune response that persisted for approximately one year in healthy adult volunteers, according to results from a Phase 1 clinical trial published in the March 14th issue of the Journal of the American Medical Association. The investigational vaccines included Ad26.ZEBOV, developed by Janssen Vaccines & Prevention B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and MVA-BN-Filo, developed by Bavarian Nordic.
February 21, 2017
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has launched a Phase 1 clinical trial to test an investigational vaccine intended to provide broad protection against a range of mosquito-transmitted diseases, such as Zika, malaria, West Nile fever and dengue fever, and to hinder the ability of mosquitoes to transmit such infections. The study, which is being conducted at the NIH Clinical Center in Bethesda, Maryland, will examine the experimental vaccine’s safety and ability to generate an immune response.
January 17, 2017
A new mouse model of early Ebola virus (EBOV) infection has shown National Institutes of Health (NIH) scientists and colleagues how early responses of the immune system can affect development of EBOV disease. The model could help identify protective immune responses as targets for developing human EBOV therapeutics.
Scientists from NIH’s National Institute of Allergy and Infectious Diseases led the study with colleagues from the University of Washington and Columbia University.
October 12, 2016
A clinical trial to evaluate the experimental Ebola treatment ZMapp found it to be safe and well-tolerated; however, because of the waning Ebola epidemic, the study enrolled too few people to determine definitively whether it is a better treatment for Ebola virus disease (EVD) than the best available standard of care alone. The findings from the randomized, controlled trial known as PREVAIL II appear in the October 13th issue of The New England Journal of Medicine.
August 22, 2016
Scientists funded by the National Institutes of Health (NIH) have successfully treated monkeys several days after the animals were infected with Sudan ebolavirus (SUDV). The study is important, according to the researchers, because no proven treatments against SUDV exist and little is known about the window of opportunity for treating the infection.