NIAID/GSK experimental Ebola vaccine appears safe, prompts immune response
Results from NIH phase 1 clinical trial support accelerated development of candidate vaccine
2014-11-27
(Press-News.org) An experimental vaccine to prevent Ebola virus disease was well-tolerated and produced immune system responses in all 20 healthy adults who received it in a Phase 1 clinical trial conducted by researchers from the National Institutes of Health. The candidate vaccine, which was co-developed by the NIH's National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK), was tested at the NIH Clinical Center in Bethesda, Maryland. The interim results are reported online in advance of print in the New England Journal of Medicine.
"The unprecedented scale of the current Ebola outbreak in West Africa has intensified efforts to develop safe and effective vaccines, which may play a role in bringing this epidemic to an end and undoubtedly will be critically important in preventing future large outbreaks," said NIAID Director Anthony S. Fauci, M.D. "Based on these positive results from the first human trial of this candidate vaccine, we are continuing our accelerated plan for larger trials to determine if the vaccine is efficacious in preventing Ebola infection."
The candidate NIAID/GSK Ebola vaccine was developed collaboratively by scientists at the NIAID Vaccine Research Center (VRC) and at Okairos, a biotechnology company acquired by GSK. It contains segments of Ebola virus genetic material from two virus species, Sudan and Zaire. The Ebola virus genetic material is delivered by a carrier virus (chimpanzee-derived adenovirus 3 or cAd 3) that causes a common cold in chimpanzees but causes no illness in humans. The candidate vaccine does not contain Ebola virus and cannot cause Ebola virus disease.
The trial enrolled volunteers between the ages of 18 and 50. Ten volunteers received an intramuscular injection of vaccine at a lower dose and 10 received the same vaccine at a higher dose. At two weeks and four weeks following vaccination, the researchers tested the volunteers' blood to determine if anti-Ebola antibodies were generated. All 20 volunteers developed such antibodies within four weeks of receiving the vaccine. Antibody levels were higher in those who received the higher dose vaccine.
The investigators also analyzed the research participants' blood to learn whether the vaccine prompted production of immune system cells called T cells. A recent study by VRC scientist Nancy J. Sullivan, Ph.D., and colleagues showed that non-human primates inoculated with the candidate NIAID/GSK vaccine developed both antibody and T-cell responses, and that these were sufficient to protect vaccinated animals from disease when they were later exposed to high levels of Ebola virus.
The experimental NIAID/GSK vaccine did induce a T-cell response in many of the volunteers, including production of CD8 T cells, which may be an important part of immune protection against Ebola viruses. Four weeks after vaccination, CD8 T cells were detected in two volunteers who had received the lower dose vaccine and in seven of those who had received the higher dose.
"We know from previous studies in non-human primates that CD8 T cells played a crucial role in protecting animals that had been vaccinated with this NIAID/GSK vaccine and then exposed to otherwise lethal amounts of Ebola virus," said Julie E. Ledgerwood, D.O., a VRC researcher and the trial's principal investigator. "The size and quality of the CD8 T cell response we saw in this trial are similar to that observed in non-human primates vaccinated with the candidate vaccine."
There were no serious adverse effects observed in any of the volunteers, although two people who received the higher dose vaccine did develop a briefly lasting fever within a day of vaccination.
INFORMATION:
Additional details about this trial, VRC 207, are available at ClinicalTrials.gov using the identifier NCT02231866.
For more information about early-stage Ebola vaccine clinical trials, see Questions and Answers: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine.
NIAID conducts and supports research--at NIH, throughout the United States, and worldwide--to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
About the National Institutes of Health (NIH)
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
NIH...Turning Discovery Into Health®
References
JE Ledgerwood et al. Safety and immunogenicity of chimpanzee adenovirus vector Ebola vaccine: preliminary report. New England Journal of Medicine DOI: 10.1056/NEJMoa1410863 (2014).
DA Stanley et al. Chimpanzee adenovirus vaccine generates acute and durable protective immunity against ebolavirus challenge. Nature Medicine DOI: 10.1038/nm.3702 (2014).
[Attachments] See images for this press release:
ELSE PRESS RELEASES FROM THIS DATE:
2014-11-26
ANN ARBOR--The spaghetti-like internal structure of most plastics makes it hard for them to cast away heat, but a University of Michigan research team has made a plastic blend that does so 10 times better than its conventional counterparts.
Plastics are inexpensive, lightweight and flexible, but because they restrict the flow of heat, their use is limited in technologies like computers, smartphones, cars or airplanes--places that could benefit from their properties but where heat dissipation is important. The new U-M work could lead to light, versatile, metal-replacement ...
2014-11-26
MINNEAPOLIS - The majority of people with dementia have never seen a doctor about their memory and thinking problems, according to a new study published in the November 26, 2014, online issue of Neurology®, the medical journal of the American Academy of Neurology.
In the study, 55 percent of the people with dementia had never had an evaluation of their thinking and memory skills with a doctor.
"These results suggest that approximately 1.8 million Americans over the age of 70 with dementia have never had an evaluation of their cognitive abilities," said study author ...
2014-11-26
ANN ARBOR, Mich. -- Despite clear signs that their memory and thinking abilities have gone downhill, more than half of seniors with these symptoms haven't seen a doctor about them, a new study finds.
University of Michigan researchers and their colleagues say their findings suggest that as many as 1.8 million Americans over the age of 70 with dementia are not evaluated for cognitive symptoms by a medical provider, which in some patients can lead to a failure to uncover modifiable causes of thinking or memory impairment.
The study, published online in Neurology, the ...
2014-11-26
Juvenile offenders with multiple psychiatric disorders when they are incarcerated in detention centers appear to be at high risk for disorders five years after detention, according to a report published online by JAMA Psychiatry.
Psychiatric disorders are prevalent among juvenile detainees. However, far less is known about the young people after they leave detention.
Karen M. Abram, Ph.D., of the Northwestern University Feinberg School of Medicine, Chicago, and co-authors looked at patterns of comorbidity (the presence of two or more disorders), how they change over ...
2014-11-26
FLAGSTAFF, Ariz. -- Nov. 26, 2014 -- An international team of scientists from the Translational Genomics Research Institute (TGen) and The Luxembourg Centre for Systems Biomedicine (LCSB) have completed a first-of-its-kind microbial analysis of a biological wastewater treatment plant that has broad implications for protecting the environment, energy recovery and human health.
The study, published Nov. 26 in the scientific journal Nature Communications (DOI: 10.1038/ncomm6603), describes in unprecedented detail the complex relationships within a model ecosystem.
The ...
2014-11-26
Johns Hopkins researchers report that their test of an interventional X-ray guidance device approved by the U.S. Food and Drug Administration in 2013 has the potential to reduce the radiation exposure of patients undergoing intra-arterial therapy (IAT) for liver cancer.
In a report prepared for presentation Dec. 3 at the 100th annual meeting of the Radiological Society of North America in Chicago (abstract #SSM24-02), the researchers described the results of a clinical trial of the imaging system AlluraClarity, made by Philips Healthcare, on 50 patients with liver cancer. ...
2014-11-26
Plasmid DNA attached to the outer surface of a sounding rocket may be able to withstand rocket launch, a period of residence in suborbital space, re-entry, and landing conditions into the Earth's atmosphere, all the while staying intact and active in its function as carrier of genetic information, according to a study published November 26, 2014 in the open-access journal PLOS ONE by Cora Thiel and Oliver Ullrich from University of Zurich and colleagues.
DNA plays an important role as a biomarker for the search of extraterrestrial signatures of life, and scientists are ...
2014-11-26
Potential 'vampires' buried in northwestern Poland with sickles and rocks across their bodies were likely local and not immigrants to the region, according to a study published November 26, 2014 in the open-access journal PLOS ONE by Lesley Gregoricka from University of South Alabama and colleagues.
In northwestern Poland, apotropaic funerary rites--a traditional practice intended to prevent evil--occurred throughout the 17th-18th c. AD. Those of the dead considered at risk for becoming vampires for a variety of reasons were given specific treatment, and investigating ...
2014-11-26
Shifts in the timing and duration of ice cover, especially the possible lengthening of ice-free periods, may impact polar bears under projected warming before the end of the 21st century, according to a study published November 26, 2014 in the open-access journal PLOS ONE by Stephen Hamilton from University of Alberta and colleagues.
Sea ice across the Arctic is declining and altering physical characteristics of marine ecosystems, and polar bears are vulnerable to these changes in sea ice conditions. The authors of this study used sea ice projections for the Canadian ...
2014-11-26
Induced pluripotent stem cells made from patients with a form of blistering skin disease can be genetically corrected and used to grow back healthy skin cells in laboratory dishes, researchers at the Stanford University School of Medicine have found. They've termed the new technique "therapeutic reprogramming."
The skin cells formed normal human skin when grafted onto the backs of laboratory mice, they said.
The findings represent a major advance in the battle against the disease, epidermolysis bullosa, in which the top layer of skin, called the epidermis, sloughs off ...
LAST 30 PRESS RELEASES:
[Press-News.org] NIAID/GSK experimental Ebola vaccine appears safe, prompts immune response
Results from NIH phase 1 clinical trial support accelerated development of candidate vaccine
