2015 Annual Report Selected Highlights

Spotlight on Ebola

Treatment and Solutions in the Ebola Crisis

The Ebola outbreak in West Africa and subsequent isolated cases in the United States dominated the news headlines in late 2014. NIH has played a leading role in research on potentially lifesaving Ebola vaccines and providing crucial scientific knowledge on the virus's genetic makeup and transmission. This year, the NIH Clinical Center was also in the spotlight for providing highly specialized, state-of-the-art isolation and treatment for one of the first patients to become infected with Ebola on U.S. soil.

History

For much of its history, Ebola was simply one of an estimated 7,000 rare diseases that NIH and other research organizations investigate. However, in 2014 the number of Ebola cases in West Africa exploded, with the Director-General of the World Health Organization, Dr. Margaret Chan, calling the outbreak "the greatest peacetime challenge that the United Nations and its agencies have ever faced."

Ebola was first recognized in 1976 in Zaire (now the Democratic Republic of Congo). Over the next four decades, only small, sporadic outbreaks (typically in remote, rural villages) were reported. Then the recent epidemic struck West Africa in March 2014. This epidemic for the first time involved large cities and was magnitudes larger than all previous outbreaks combined: as of November 14, 2014, more than 13,000 people were infected and 37% of the afflicted had died. A concurrent outbreak in the Democratic Republic of Congo started in August 2014 and infected 66 people through November 2014, with a 74% mortality rate.

Scientists, including NIH researchers, have used advanced genomic sequencing technology to map the origins of the disease. They determined that the current outbreak was caused by a single transmission from animal to human, followed by exclusively human-to-human transmissions. The virus can be spread among humans through direct contact (through broken skin or mucous membranes in, for example, the eyes, nose or mouth) with blood or body fluids of a person who is sick with Ebola or through virus-contaminated objects like needles and syringes.

Ebola in the U.S.

Only a small number of confirmed Ebola cases have been confirmed in the United States. As of November 2014, five cases were detected in medical or other professionals who had returned from West Africa after helping to contain or monitor the health crisis. One case involved a man who had traveled from Liberia to Dallas, Texas. Two subsequent cases were detected in nurses who had been involved in his care. The two Dallas nurses are the only two confirmed cases of Ebola transmission in the United States.

Treatment at the Clinical Center

On October 16, 2014, Nina Pham, one of the nurses from Texas who was infected, was transferred to the NIH Clinical Center's Special Clinical Studies Unit, one of a small number of containment facilities in the United States designed to provide high-level isolation capabilities.

For each patient infected with a highly contagious virus such as Ebola, a large number of specially trained professionals, including physicians, nurses and support staff, are required to provide constant care and maintain stringent infection control procedures.

"We are thoroughly convinced that the policies at the highest levels of safe containment were effective," said Dr. Richard Davey of the National Institute of Allergy and Infectious Diseases (NIAID), who runs the Special Clinical Studies Unit. He noted that dozens of unit staff "all pulled together in an amazing way. I can't compliment them enough. The esprit was overwhelming. Our infection control measures exceed the guidelines and have been thoroughly tested."

"This was our first opportunity to study a patient with Ebola," said Dr. H. Clifford Lane, clinical director of NIAID. "There's an enormous amount we think we'll be able to learn with one patient... Even though this is a tiny percent of what's going on in West Africa, it could extend the benefits of our research there... This patient [Pham] is part of a substantial research program."

Pham received no experimental drugs at the Clinical Center during her treatment. She did receive a transfusion of plasma that had been donated by Dr. Kent Brantly who had previously recovered from Ebola virus infection. One hypothesis, not yet proven, is that antibodies circulating in those who have recovered from Ebola offer protection to patients who have been exposed to or are developing infection with Ebola.

Pham was discharged on October 24, after five polymerase chain reaction (PCR) blood tests showed that she was free of the Ebola virus. PCR tests detect the genetic material of the virus and are the most sensitive tests available to identify Ebola infection.

In addition to Pham, the NIH Clinical Center treated two medical personnel who were exposed to the Ebola virus while treating patients in Africa. Both were treated in the SCSU and were discharged when it was confirmed that they had not developed symptoms of infection.

Vaccine Development

NIH is playing a key role in international collaborations among private and public partners to accelerate the translation of decades of research into safe, effective Ebola vaccines.

Starting in September 2014, NIAID began testing two versions of an investigational vaccine co-developed by NIAID and GlaxoSmithKline at the NIH Clinical Center. Twenty healthy adult volunteers received a version containing genetic material derived from both the Zaire and Sudan Ebola virus strains, and another 20 adults received a monovalent version derived from only the Zaire Ebola species. This current candidate vaccine builds on three earlier NIAID-developed investigational Ebola vaccines which began Phase 1 clinical trial testing in 2003.

Separately, the NIH also began collaborate with the U.S. Department of Defense to support NewLink Genetics Corp., a biopharmaceutical company in Iowa, in conducting Phase 1 safety studies of the investigational recombinant vesicular stomatitis virus Ebola vaccine, called VSV-EBOV, developed by and licensed from the Public Health Agency of Canada. Those clinical trials began in the fall at the Clinical Trials Center of Walter Reed Army Institute of Research in Maryland.

In addition to the investigational vaccines entering Phase 1 clinical trials, NIAID is supporting a variety of organizations in developing other vaccine approaches, including a multivalent Ebola/Marburg vaccine and investigational vaccine candidates against the Ebola, Marburg and rabies viruses.

For more information on the Ebola virus, visit www.cc.nih.gov/ebola.html.

Nina Pham, her family and NIH health care team
Nina Pham, the Texas nurse who was the first patient diagnosed with Ebola to be treated at the Clinical Center, joins her family and the NIH health care team that cared for her to celebrate her discharge from the hospital.

Electron micrograph of Ebola virus
Scanning electron micrograph of Ebola virus budding from the surface of a Vero cell (African green monkey kidney epithelial cell line). Credit: National Institute of Allergy and Infectious Diseases (NIAID)

President Barack Obama with CC staff
President Barack Obama visited the Clinical Center and Vaccine Research Center at the National Institutes of Health on Dec. 2, 2014. Obama was briefed on the investigational Ebola vaccine currently being tested at NIH. He then spoke at the Clinical Center on the need for continued research into the Ebola virus, U.S. assistance in treating Ebola in West Africa and the exemplary work of Clinical Center staff in treating Dallas nurse Nina Pham's Ebola infection.

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