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ZMapp Ebola Trial Starts In Liberia: Is It Too Late?

FORBES   by   David Kroll                                                                                          March 1, 2015

The widely-discussed antibody cocktail, ZMapp, is finally going to be tested under standardized, controlled conditions for its safety and efficacy in Ebola virus disease-infected patients in Liberia and, potentially, the United States.

Late Friday, the NIH National Institute of Allergy and Infectious Disease (NIAID) announced the launch of a randomized trial in up to 200 patient volunteers with confirmed Ebola virus infections.

The two-arm study will compare supportive standard of care with or without three intravenous infusions of ZMapp spaced three days apart. This is the same dosing regimen published in Nature that protected 18 of 18 monkeys when given up to five days after experimental infection.

LeafBio, the commercial arm of San Diego-based Mapp Biopharmaceutical, announced concomitantly that the FDA had approved their IND for this trial. The three antibodies that comprise ZMapp target both distinct and overlapping parts of the Ebola virus glycoprotein (GP) that it uses to infect humans.

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Decision on Ebola mass vaccination in August at earliest: WHO

REUTERS by Stephanie Nebehay                                                             Feb. 27, 2015

GENEVA -- An independent advisory body will decide in August at the earliest on whether to recommend widespread introduction of an Ebola vaccine, depending on results of clinical trials and the epidemic's course, the World Health Organization said on Friday.

All three worst-hit countries in West Africa - Guinea, Liberia and Sierra Leone - aim to conduct phase III final-stage clinical trials of experimental vaccines.

Liberia is already testing both the GlaxoSmithKline and Merck-NewLink vaccines, while Sierra Leone and Guinea are due to announce plans soon....

WHO spokesman Christian Lindmeier, reporting on a three-day meeting of experts, told a news briefing: "Vaccine introduction is by no means a given and will depend on the results of clinical trials and recommendations from WHO's Strategy Advisory Group of Experts (SAGE) on vaccines and immunization....

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2 leading Ebola vaccines appear safe, WHO says

ASSOCIATED PRESS by Maria Cheng                                                                                 Feb. 23, 2015

LONDON – The World Health Organization says the two leading Ebola vaccines appear safe and will soon be tested in healthy volunteers in West Africa.

After an expert meeting this week, WHO said there is now enough information to conclude that the two most advanced Ebola vaccines — one made by GlaxoSmithKline and the other licensed by Merck and NewLink — have "an acceptable safety profile."

In a press briefing Friday, Dr. Marie-Paule Kieny, who heads WHO's Ebola vaccine efforts, said "the cupboard (for Ebola vaccines) is filling up rapidly."

She said further trials in healthy people in West Africa, including health workers, are scheduled to start soon. Kieny added several other vaccines were being developed in the U.S., Russia and elsewhere.

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http://www.baxterbulletin.com/story/life/health/2015/02/23/leading-ebola-vaccines-appear-safe-says/23901829/

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Scientists warn against complacency on Ebola vaccines

AFP                                                                                                                    Feb. 17, 2015

London--  A team of leading international scientists on Tuesday called for new Ebola vaccines to be made available in months rather than years and warned against complacency after a reduction in infection rates.

(Scroll down for link to complete report.)

"Despite falling infection rates in west Africa, the risk that the current Ebola outbreak may not be brought completely under control remains," said Jeremy Farrar, director of the Wellcome Trust, Britain's biggest medical charity.

"The accelerated development of candidate vaccines... is essential," said Farrar, who co-chairs a group of 26 international experts on vaccine development.

Read complete story.

http://news.yahoo.com/scientists-warn-against-complacency-ebola-vaccines-004937305.html;_ylt=AwrBEiHDVuNUhDcAfsPQtDMD

Recommendations for Accelerating the Development of Ebola Vaccines: Report & Analysis

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Nobody Is Sure Why A Promising Ebola Drug Trial Ended

The company producing the new Ebola treatment for an FDA-approved test suddenly pulled out of Liberia, leaving researchers confused.

BUZZFEED                by Hayes Brown                                                                               Feb. 13, 2015

...An FDA-approved trial of the drug brincidofovir, meant to treat rather than prevent Ebola, had already begun in Liberia’s capital of Monrovia when Chimerix, the company that produced the drug, pulled out of the trial at the end of January. The clinical trial partners decided to end the trial on Feb. 3.

Peter Horby, who led the University of Oxford research team conducting the study, called the drug company’s decision “a bit abrupt.”

A woman is injected by a health care worker as she takes part in an Ebola virus vaccine trial in Monrovia Abbas Dulleh / Via AP

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Human trial of 4th Ebola vaccine launches in Australia

CENTER FOR INFECTIOUS DISEASE AND POLICY by  Lisa Schnirring                                                      Feb. 13, 2015

Novavax yesterday announced the launch of the first human trial of its recombinant Ebola vaccine, which will make it the fourth candidate vaccine to be tested in phase 1 trials.

Novavax's product is a glycoprotein recombinant nanoparticle vaccine adjuvanted with Matrix M (Ebola GP) to boost immune response. Conducted in Australia, the study will test the safety and immunogenicity of the vaccine, with and without the adjuvant, in 230 healthy adults ages 18 to 50. Subjects will be given two intramuscular injections 3 weeks apart....

Three other Ebola vaccines are in clinical trials. Phase 2 and 3 studies of the two vaccines that are furthest along in trials got under way in Liberia at the end of January. They include two vector virus vaccines, ChAd3, developed by the National Institutes of Health (NIH) and GlaxoSmithKline (GSK), and VSV-EBOV, developed by the Canadian government and licensed by NewLink Genetics and Merck.

A phase 1 trial of a prime-boost Ebola vaccine regimen from Johnson & Johnson launched in early January in the United Kingdom.

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Ebola virus evolution tracked by genetic data

SCIENCE NEWS by Ashley Yaeger                               Feb. 14, 2015
SAN JOSE, Calif. — Genetic data are beginning to reveal how the Ebola virus causing the epidemic in Western Africa is evolving.

            LITTLE TWEAKS  A detailed look at genomes of the Ebola virus has pinpointed mutations that may make one type  of experimental therapy less effective. Cynthia Goldsmith/CDC

Scientists have deciphered the entire catalog of genetic data for 96 Ebola viruses taken from patients infected in 2014 during the first four months of the outbreak.

The results show that one particular clade, or type of the virus, is dominant among patients in Sierra Leone, suggesting that two other clades that dominated early on in the outbreak have died out.

This third clade appears to have evolved starting with a single mutation in the genetic catalog, or genome, of the virus, said Stephen Gire of Harvard University and the Broad Institute in Cambridge, Mass. He presented the preliminary findings February 14 at the annual meeting of the American Association for the Advancement of Science.

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Use of Group Quarantine in Ebola Control — Nigeria, 2014

Morbidity and Mortality Weekly Report (MMWR)

CDC                                                                                                                            Feb. 13, 2015

by Cheri Grigg, DVM1,2, Ndadilnasiya E. Waziri, DVM3, Adebola T. Olayinka, MD3, John F. Vertefeuille, PhD4

On July 20, 2014, the first known case of Ebola virus disease (Ebola) in Nigeria, in a traveler from Liberia  led to an outbreak that was successfully curtailed with infection control, contact tracing, isolation, and quarantine measures coordinated through an incident management system.

During this outbreak, most contacts underwent home monitoring, which included instructions to stay home or to avoid crowded areas if staying home was not possible. However, for five contacts with high-risk exposures, group quarantine in an observation unit was preferred because the five had crowded home environments or occupations that could have resulted in a large number of community exposures if they developed Ebola.

Read complete report.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6405a3.htm?s_cid=mm6405a3_x

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Lack of Effect of Lamivudine on Ebola Virus Replication

CDC EID JOURNAL by  Lisa E. Hensley, Julie Dyall, Gene G. Olinger, and Peter B. Jahrlin (NIH)                     Feb. 12, 2015

The unprecedented number of Ebola virus disease (EVD) cases in western Africa has compelled the world to consider experimental and off-label therapeutics to mitigate the current outbreak. For clinicians, approved drugs are an attractive solution because of known safety profiles and availability.

Oral lamivudine (GlaxoSmithKline, Brentford, UK), a US Food and Drug Administration–approved anti-HIV drug, has been suggested as a possible antiviral agent against Ebola virus (EBOV). In September 2014, a Liberian physician, Dr. Gorbee Logan, reported positive results while treating EVD with lamivudine (1). Thirteen of 15 patients treated with lamivudine survived presumed EVD and were declared virus free. Clinical confirmation of EVD in these cases remains to be verified....

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Postmortem Stability of Ebola Virus

CDC  EID JOURNAL                                              Feb. 12, 2015                                   
Study by Joseph Prescott, Trenton Bushmaker, Robert Fischer, Kerri Miazgowicz, Seth Judson, and Vincent J. Munster

The ongoing Ebola virus outbreak in West Africa has highlighted questions regarding stability of the virus and detection of RNA from corpses. We used Ebola virus–infected macaques to model humans who died of Ebola virus disease.

Assessing the stability of corpse-associated virus and determining the most efficient sampling methods for diagnostics will clarify the safest practices for handling bodies and the best methods for determining whether a person has died of EVD and presents a risk for transmission. To facilitate diagnostic efforts, we studied nonhuman primates who died of EVD to examine stability of the virus within tissues and on body surfaces to determine the potential for transmission, and the presence of viral RNA associated with corpses.

http://wwwnc.cdc.gov/eid/article/21/5/15-0041_article

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