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VRC Biodefense Activities

Recent Science Advances:

• SARS: NIAID scientists demonstrated that a DNA vaccine encoding part of the SARS virus spike protein protects mice against a murine form of SARS. The vaccine induced both cellular and humoral immune responses, with protection against SARS conferred by anti-viral neutralizing antibodies. This was confirmed by transferring immune sera from immunized mice into naïve mice. The immune sera containing antibodies against the SARS virus was protective in naïve mice challenged with SARS. These observations suggest that vaccines that induce neutralizing antibodies, and strategies for immunoprophylaxis or immunotherapy, are likely to be effective in SARS. The researchers also found that the SARS virus replicates in the respiratory tract of mice to levels that would allow evaluation of vaccines, immunotherapeutics, and antiviral drugs. These findings could help decrease the time it takes to develop an effective vaccine or antiviral drugs for SARS.

New Activities

• Ebola: In FY04, the first human clinical trial of a vaccine designed to protect against Ebola was initiated. The vaccine was developed at the Vaccine Research Center in collaboration with researchers at the Centers for Disease Control (CDC) and the United States Army Medical Research Institute for Infectious Diseases (USAMRIID).

Ongoing Activities

• WNV: The NIAID Vaccine Research Center is currently developing a DNA-based vaccine against West Nile virus in collaboration with the San Diego based biotechnology company, Vical, Inc. The vaccine is based on an existing codon modified gene-based DNA plasmid vaccine platform designed to express WNV proteins. In April 2005, following pre-clinical safety studies and viral challenge studies, the VRC initiated a Phase I clinical trial to evaluate safety, tolerability, and immune responses of this recombinant DNA vaccine in human volunteers. Also in collaboration with Vical Inc., the VRC is currently developing a second generation DNA vaccine using an improved expression vector expressing the same WNV proteins. A Phase I clinical trial is planned for spring, 2006.
• SARS: The Vaccine Research Center (VRC) contracted with Vical, Inc. to manufacture a single closed, circular DNA plasmid based vaccine encoding the S protein of SARS-CoV. VRC mouse studies demonstrated that this vaccine induces T cell and neutralizing antibody responses, as well as protective immunity. A Phase I open-label clinical study to evaluate safety, tolerability, and immune response was initiated in FY 2005. The study enrolled 10 healthy 18-50 years old subjects, and administered 4 mg DNA vaccinations at three one month intervals. Interim study results indicate that the vaccine is well tolerated and the study is expected to be complete early in FY 2006.
• Ebola: The Vaccine Research Center is currently testing a fast-acting candidate Ebola vaccine that protects monkeys exposed to the virus one month after immunization. Such a vaccine would be especially useful in an acute outbreak setting. If this vaccine proves similarly effective in humans, it could one day be used to quickly contain Ebola outbreaks with ring vaccination-the same strategy used in the past against smallpox. A 2nd generation product may also be evaluated that would potentially provide coverage for Marburg and possibly Lassa virus. The VRC/NIAID continues to collaborate with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) under an Inter-Agency Agreement to develop vaccine strategies for Ebola and other viral hemorrhagic fevers.
• Smallpox: The Vaccine Research Center is currently testing Modified Vaccinia Ankara (MVA) as an attenuated poxvirus with the potential to protect against vaccinia (the virus used to vaccinate against smallpox) or variola (the virus that causes smallpox). The vaccine was provided by Therion Biologics Corporation as part of a collaboration with the VRC. Two Phase I clinical trials testing MVA as a component of a safer smallpox vaccine in both vaccinia naïve and vaccinia immune populations have recently concluded.
• CRADAS:
  • NIAID and Crucell B.V.: Development of an Improved Recombinant Adenovirus Vector for Vaccination Against the Ebola Virus>
  • NIAID and Vical, Inc.: Development and selection of research-grade plasmid DNA vectors encoding West Nile Virus (WNV) proteins and formulations for potential use as prophylactic vaccines in human and veterinary applications.
  • NIAID and GenVec, Inc.: Evaluation of Adenoviral Vectors Encoding Proteins Associated with SARS

Conferences, Symposia, Meetings

• Ebola, Lassa, Marburg : On October 14-17, 2003, the Vaccine Research Center, NIAID held a symposium on Viral Hemorrhagic Fevers (VHF), including such agents as Ebola, Lassa, Marburg, and Hanta. National and international experts from government, academia, and industry convened to review areas of basic research that can best guide the development of vaccines and therapeutics against these and other VHF agents, and to develop research priorities.