NIH part of international consortium to speed Ebola vaccine trials
The National Institutes of Health (NIH) has partnered with an international-based consortium based in Britain to fast-forward work on an Ebola virus vaccine developed by GSK that has shown promise in nonhuman primate studies. The first phase 1 human trial is slated to start next week by scientists from the NIH's National Institute of Allergy and Infectious Diseases (NIAID), with similar trials starting next month in the United Kingdom, Gambia, and Mali.
The international consortium includes the Wellcome Trust and Britain's Medical Research Council and Department for International Development. A $4.6 million grant from the groups will allow researchers at the University of Oxford to start parallel safety tests of the vaccine, which are slated to begin in the middle of September as soon as the groups receive expedited ethical and regulatory approvals.
GSK said in a statement that the consortium's funding will allow the company to start making up to 10,000 more doses of the vaccine at the same time clinical trials are being done so that if the trials are successful, the company can immediately get supplies to the World Health Organization for emergency immunization campaigns targeted to high-risk areas.
The company's vaccine candidate is aimed at the Zaire species of Ebola, which is the one responsible for West Africa's outbreak. It uses a single Ebola virus protein to induce an immune response and does not contain infectious virus, GSK said. It said the NIH is providing vaccine for the Oxford group's trial and is also testing a related vaccine designed to protect against two Ebola strains—Zaire and Sudan.
If the vaccine appears to be safe and effective in the Oxford trial, research teams will use it to launch trials in Gambia and Mali that are designed to test different dosages. GSK said the addition of the two West African arms of the study is intended to ensure that the trials account for differences in European and African populations that might affect safety and immune response.
Aug 28 NIH press release
Aug 28 GSK press release
Aug 28 Wellcome Trust press release
Treatment of US Ebola patients yields clinical pearls
The recent treatment of two US medical workers who were infected with Ebola virus in Liberia at Emory University Hospital in Atlanta offered an unprecedented opportunity to observe the course of the disease and its treatment in a well-equipped and -staffed setting, yielding lessons that could help doctors working in the field in West Africa's outbreak, according to a report yesterday in Scientific American.
One of the magazine's writers, Dina Fine Maron, interviewed Bruce Ribner, MD, an internal medicine doctor who led the team that treated patients Kent Brantly, MD, and Nancy Writebol at the facility. Both recovered from the disease and were released from the hospital last week.
Ribner said hospitals and treatment centers in the outbreak countries don't have the capacity to measure important parameters, such as electrolyte and blood protein levels, but clinical interventions can be used to address both issues, even in the absence of testing. He said both patients had low sodium and potassium levels, a consequence of fluid loss after bouts of vomiting and diarrhea. Even if clinicians in Africa can't measure the levels, it's important to be aware that the levels could be low in fluid-loss instances.
Ribner also said that both patients had edema, the fluid loss into tissues resulting from liver damage and resulting insufficient protein levels in the blood. "So one of the takeaway messages is to pay closer attention to that and perhaps early on try to replace some of these proteins that patients' livers lack," he said.
Upon discharge, the two patients were given the standard US Centers for Disease Control and Prevention recommendation to avoid having unprotected sex for 3 months, Ribner said. He added that while studies have shown that after recovery Ebola patients can shed genetic material from the virus in semen and vaginal secretions, there have been little attempts to show that people shed viable virus.
Media reports said Brantly received convalescent serum and that both patients received the experimental Ebola drug ZMapp. Ribner said, however, that it's not clear if the treatments were beneficial. He added that the benefits of airlifting patients to developed countries include replacement of fluid and electrolytes, platelets, and blood proteins.
"I think one of the messages that is going out from many sources is we really have to help countries such as the ones involved in this outbreak to develop their medical infrastructure. Hopefully in five years they will have this infrastructure," Ribner said.
Aug 27 Scientific American report