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GAITHERSBURG, Md., May 11, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), today announced that Dr. James F. Cummings has been promoted to Vice President, Clinical Development and Translational Medicine. Dr. Cummings joined Novavax as Senior Director of Clinical Development in September 2015, with a specific focus on advancing Novavax’ programs within emerging infectious disease.  Previously, Dr. Cummings served as the Director for Global Emerging Infections Surveillance and Response System (GEIS) at the Armed Forces Health Surveillance Branch (AFHSB), Director, Translational Medicine Branch & Division of Regulated Activities at Walter Reed Army Institute of Research (WRAIR) and Consultant to the U.S. Army Surgeon General for all Medical Research and Development. “In his short tenure at the company, James has shown his ability to constructively organize, motivate and manage complex development programs,” said Stanley C. Erck, President and CEO. “His demonstrated expertise in product development and leadership capabilities earned James the appointment of Project Lead for our nanoparticle influenza vaccine candidate development program, and promotion to Vice President. I am thrilled to congratulate James for his successes here at Novavax.” About Novavax Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.


GAITHERSBURG, Md., May 11, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), today announced that Dr. James F. Cummings has been promoted to Vice President, Clinical Development and Translational Medicine. Dr. Cummings joined Novavax as Senior Director of Clinical Development in September 2015, with a specific focus on advancing Novavax’ programs within emerging infectious disease.  Previously, Dr. Cummings served as the Director for Global Emerging Infections Surveillance and Response System (GEIS) at the Armed Forces Health Surveillance Branch (AFHSB), Director, Translational Medicine Branch & Division of Regulated Activities at Walter Reed Army Institute of Research (WRAIR) and Consultant to the U.S. Army Surgeon General for all Medical Research and Development. “In his short tenure at the company, James has shown his ability to constructively organize, motivate and manage complex development programs,” said Stanley C. Erck, President and CEO. “His demonstrated expertise in product development and leadership capabilities earned James the appointment of Project Lead for our nanoparticle influenza vaccine candidate development program, and promotion to Vice President. I am thrilled to congratulate James for his successes here at Novavax.” About Novavax Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.


GAITHERSBURG, Md., May 11, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), today announced that Dr. James F. Cummings has been promoted to Vice President, Clinical Development and Translational Medicine. Dr. Cummings joined Novavax as Senior Director of Clinical Development in September 2015, with a specific focus on advancing Novavax’ programs within emerging infectious disease.  Previously, Dr. Cummings served as the Director for Global Emerging Infections Surveillance and Response System (GEIS) at the Armed Forces Health Surveillance Branch (AFHSB), Director, Translational Medicine Branch & Division of Regulated Activities at Walter Reed Army Institute of Research (WRAIR) and Consultant to the U.S. Army Surgeon General for all Medical Research and Development. “In his short tenure at the company, James has shown his ability to constructively organize, motivate and manage complex development programs,” said Stanley C. Erck, President and CEO. “His demonstrated expertise in product development and leadership capabilities earned James the appointment of Project Lead for our nanoparticle influenza vaccine candidate development program, and promotion to Vice President. I am thrilled to congratulate James for his successes here at Novavax.” About Novavax Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.


GAITHERSBURG, Md., May 11, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), today announced that Dr. James F. Cummings has been promoted to Vice President, Clinical Development and Translational Medicine. Dr. Cummings joined Novavax as Senior Director of Clinical Development in September 2015, with a specific focus on advancing Novavax’ programs within emerging infectious disease.  Previously, Dr. Cummings served as the Director for Global Emerging Infections Surveillance and Response System (GEIS) at the Armed Forces Health Surveillance Branch (AFHSB), Director, Translational Medicine Branch & Division of Regulated Activities at Walter Reed Army Institute of Research (WRAIR) and Consultant to the U.S. Army Surgeon General for all Medical Research and Development. “In his short tenure at the company, James has shown his ability to constructively organize, motivate and manage complex development programs,” said Stanley C. Erck, President and CEO. “His demonstrated expertise in product development and leadership capabilities earned James the appointment of Project Lead for our nanoparticle influenza vaccine candidate development program, and promotion to Vice President. I am thrilled to congratulate James for his successes here at Novavax.” About Novavax Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.


GAITHERSBURG, Md., May 11, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), today announced that Dr. James F. Cummings has been promoted to Vice President, Clinical Development and Translational Medicine. Dr. Cummings joined Novavax as Senior Director of Clinical Development in September 2015, with a specific focus on advancing Novavax’ programs within emerging infectious disease.  Previously, Dr. Cummings served as the Director for Global Emerging Infections Surveillance and Response System (GEIS) at the Armed Forces Health Surveillance Branch (AFHSB), Director, Translational Medicine Branch & Division of Regulated Activities at Walter Reed Army Institute of Research (WRAIR) and Consultant to the U.S. Army Surgeon General for all Medical Research and Development. “In his short tenure at the company, James has shown his ability to constructively organize, motivate and manage complex development programs,” said Stanley C. Erck, President and CEO. “His demonstrated expertise in product development and leadership capabilities earned James the appointment of Project Lead for our nanoparticle influenza vaccine candidate development program, and promotion to Vice President. I am thrilled to congratulate James for his successes here at Novavax.” About Novavax Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.


News Article | November 10, 2016
Site: www.eurekalert.org

BOSTON - A study led by researchers at Beth Israel Deaconess Medical Center (BIDMC), in collaboration with scientists at Walter Reed Army Institute of Research (WRAIR), Janssen Vaccines & Prevention B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson and Gilead Sciences, Inc., has demonstrated that combining an experimental vaccine with an innate immune stimulant may help lead to viral remission in people living with HIV. In animal trials, the combination decreased levels of viral DNA in peripheral blood and lymph nodes, and improved viral suppression and delayed viral rebound following discontinuation of anti-retroviral therapy (ART). The research team's findings appeared online today in the journal Nature. "The objective of our study was to identify a functional cure for HIV - not to eradicate the virus, but to control it without the need for ART," said lead author Dan Barouch, MD, PhD, Director of the Center for Virology and Vaccine Research at BIDMC. "Current antiretroviral drugs, although they're lifesaving, do not cure HIV. They merely hold it in check. We are trying to develop strategies to achieve ART-free, long-term viral suppression." Typically, vaccines "teach" the body to rid itself of viral invaders by provoking an immune response. However, HIV attacks cells of the immune system. The virus kills the majority of infected immune cells but goes dormant in others. This reservoir of dormant, infected cells, where researchers believe HIV remains hidden during antiretroviral therapy, is the primary reason HIV cannot currently be cured. Barouch and colleagues are working on strategies to draw the virus out of hiding with the goal of eradicating it from the body. "We reasoned that if we can activate the immune cells that might harbor the virus, then the vaccine-induced immune responses might perform better seeking them out and destroying them," said Barouch, who is also a Professor of Medicine at Harvard Medical School. "Indeed, we saw the best results when we combined the vaccine together with the innate immune stimulant." In the two-year long study, researchers monitored the viral loads of 36 rhesus monkeys infected with simian immunodeficiency virus (SIV), a virus similar to HIV that infects non-human primates. After taking suppressive ART drugs for six months, the monkeys were given either the experimental vaccines - an adenovirus serotype 26 vector vaccine and an MVA vector vaccine (Ad26/MVA) - alone, the immune stimulant (an experimental drug that works on a protein of the immune system called TLR-7) alone, or the Ad26/MVA and stimulant combination. A control group received no active treatment. "We found the combination of Ad26/MVA vaccination and TLR7 stimulation proved more effective than either component alone," said Col. Nelson Michael, director of MHRP, who helped design the preclinical study. "This was especially striking in viral load set-point, which impacts the future course of the disease." The experimental vaccine induced a robust immune response, both in magnitude (the number of immune cells generated) and breadth (the number of places on the virus the vaccine can targets). To evaluate the efficacy of the vaccine and the immune stimulant, the researchers discontinued ART in all animals and continued to monitor their viral loads. Animals that received only the vaccine demonstrated some reduction of viral load, but the animals that were given the vaccine/immune stimulant combination showed a reduction in plasma viral RNA levels as well as a 2.5-fold delay of viral rebound compared to controls. All nine animals showed decreased viral loads, and the virus was undetectable in a third of the animals. "If all the animals' viral loads had been undetectable, that would have been a home run," said Barouch. "But the fact that all animals showed a reduction in viral load and three out of nine were undetectable, that's a solid base hit. It's definitely something that we can work from." Study coauthors include Erica Borducchi, Crystal Cabral, Kathryn E. Stephenson, Jinyan Liu, Peter Abbink, David Ng'ang'a, Joseph P. Nkolola, Amanda L. Brinkman, Lauren Peter, Benjamin C. Lee, Jessica Jimenez, David Jetton, Jade Modesir, Shanell Mojta, Abishek Chandrashekar and Katherine Molloy all of BIDMC; Galit Alter of the Ragon Institute of MGH, MIT, and Harvard; Jeff M. Gerold and Alison L. Hill of the Program for Evolutionary Dynamics at Harvard University; Mark G. Lewis, of Bioqual; Maria G. Pau, Hanneke Schuitemaker of Janssen Infectious Diseases and Vaccines; Joseph Hesselgesser and Romas Geleziunas of Gilead Sciences; Jerome H. Kim, Merlin L. Robb and Nelson L. Michael of the U.S. Military HIV Reseach Program, Walter Reed Army Institute of Research. This work was supported by the U.S. Army Medical Research and Material Command and the Military HIV Research Program, Walter Reed Army Institute of Research through its cooperative agreement with the Henry M. Jackson Foundation (W81XWH-11-2-0174). Funding was also provided by the National Institutes of Health (AI096040, AI124377, AI1266030) and the Ragon Institute of MGH, MIT, and Harvard. Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, MetroWest Medical Center, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www. .


News Article | February 21, 2017
Site: www.eurekalert.org

In less than one year, researchers have developed multiple vaccine platforms that provide robust protection against Zika virus challenge in animal models BOSTON - As public health officials warn that spring's warmer temperatures may herald another increase of Zika virus infections in the Caribbean and North and South America, researchers around the world are racing to develop safe and effective measures to prevent the disease. In a review paper published today in the journal Immunity, a group of leading vaccine scientists -- including Dan H. Barouch, MD, PhD, of Beth Israel Deaconess Medical Center (BIDMC) -- outline advances in the hunt for a Zika vaccine and the challenges that still lie ahead. "The pace of preclinical and early clinical development for Zika vaccines is unprecedented," said Barouch, corresponding author and director of the Center for Virology and Vaccine Research at BIDMC. "In less than a year, our group and others have demonstrated that multiple vaccine platforms can provide robust protection against Zika virus challenge in animal models. However, unique challenges will need to be addressed in the clinical development of a Zika vaccine. " The recent outbreak of the Zika virus in the Americas began in Brazil nearly two years ago. By February 2016, the World Health Organization had declared the epidemic a global public health emergency, based largely on the virus' newly-established link to microcephaly and other major birth defects in babies born to infected mothers. The virus has also been associated with the neurologic disorder Guillain-Barré syndrome in adults. In a previously published paper, Barouch and colleagues, including Colonel Nelson L. Michael, MD, PhD, director of the Military HIV Research Program at the Walter Reed Army Institute of Research (WRAIR) and Stephen Thomas, MD, Upstate Medical University, State University of New York, demonstrated that three different vaccine candidates provided robust protection against Zika virus in both mice and rhesus monkeys. Several human clinical trials began last fall at test sites including BIDMC, WRAIR, and National Institute of Allergy and Infectious Diseases affiliated clinical trial sites. "The rapid advancement of Zika vaccine candidates into clinical trials reflects the uniquely focused and effective collaboration among scientists in the field to address this important global problem," said Barouch. Despite the accelerated pace of research, much remains unknown about the virus, raising unique challenges in developing a vaccine. Safety considerations are especially critical, given that the target population for a Zika vaccine would likely include men and women of childbearing age. Zika is a member of the flavivirus family of viruses, which includes West Nile virus, yellow fever virus, and dengue viruses, for which successful vaccines have been developed. Studies suggest that Zika-induced antibody responses may also cross-react with other flaviviruses, particularly dengue virus. Whether or not this antibody cross-reactivity may have clinical consequences is another consideration for Zika vaccines and requires further study. Co-authors include: Stephen J. Thomas, MD, Upstate Medical University, State University of New York, Syracuse; and Colonel Nelson L. Michael, MD, PhD, director, Military HIV Research Program, at Walter Reed Army Institute of Research (WRAIR). The review's authors acknowledge support from the U.S. Military Research and Material Command and the U.S. Military HIV Research Program; the National Institutes of Health (AI095985, AI096040, AI100663, AI124377); and the Ragon Institute of MGH, MIT, and Harvard. Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, MetroWest Medical Center, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www. .


News Article | November 7, 2016
Site: www.eurekalert.org

SILVER SPRING, Md. - The Walter Reed Army Institute of Research (WRAIR) began vaccinations today in a Phase 1 human clinical trial to test the safety and immunogenicity of the Zika purified inactivated virus (ZPIV) vaccine. Seventy-five healthy adults will be recruited to participate in the trial at WRAIR's Clinical Trial Center in Silver Spring, Md. Given the concerns for immune enhancement with other similar flaviviruses, like yellow fever and Japanese encephalitis, ZPIV will be tested in some volunteers who will first be vaccinated against one of these other flaviviruses. This is of particular military relevance, as service members are often vaccinated against these diseases and then deployed to areas where Zika is increasingly becoming endemic. WRAIR scientists developed the ZPIV vaccine candidate earlier this year. The inactivated flavivirus vaccine platform was the same technology the Institute used to create its Japanese encephalitis vaccine, which was licensed in 2009. An earlier preclinical study found that rhesus monkeys that were vaccinated with ZPIV developed a strong immune response and were protected against two strains of Zika virus. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing, and is sponsoring the conduct of this trial. WRAIR, NIAID, and the Biomedical Advanced Research and Development Authority (BARDA) have established a joint research collaboration agreement to support the development of this vaccine. In addition to concerns about infection during deployment and travel, most military installations in the continental U.S. are concentrated in the southern states, where climate conditions and mosquito populations are favorable for Zika transmission. Col. Nelson Michael, director of WRAIR's Military HIV Research Program (MHRP) and Zika program co-lead noted that, "The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials. All of this was done in 10 months." This study is part of the U.S. Department of Defense response to the ongoing outbreak of Zika virus in North and South America and Southeast Asia. As of November 2, there were 149 confirmed cases of Zika virus within the military health system, including four pregnant service members and one pregnant family member. "Asymptomatic Zika infections can lead to severe birth defects and neurological complications. A safe and effective Zika vaccine that prevents infection in those at risk is a global public health priority," said Maj. Leyi Lin, principal investigator of the study. The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger scale manufacturing and advanced development. BARDA recently awarded a six-year contract to Sanofi Pasteur to further develop this vaccine to licensure. "The Army was able to move so quickly in developing, manufacturing and testing a Zika vaccine because of its extensive experience with this vaccine platform and long standing investments in the understanding and mitigation of flaviviruses, like yellow fever, dating back to the founding of WRAIR," said Dr. Kayvon Modjarrad, Zika program co-lead and associate director for Emerging Infectious Disease Threats at WRAIR's MHRP. WRAIR's ZPIV candidate will also be included as a part of a NIH trial that began in August. That study will test ZPIV in a group of people who first receive the DNA vaccine and then are boosted with the ZPIV vaccine. Three additional Phase 1 trials using ZPIV are scheduled to begin this year: The WRAIR trial that began today is sponsored by NIAID and funded by the Departments of the Army and Defense. About the Walter Reed Army Institute of Research Headquartered in Silver Spring, Maryland, the Walter Reed Army Institute of Research (WRAIR) is the oldest and most mission diverse biomedical research laboratory in the Department of Defense. WRAIR provides unique research capabilities and innovative solutions to a range of force health and readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations. With comprehensive research units in Africa, Asia, and the Caucasus region, WRAIR is comprised of two Centers of Excellence, the Center for Infectious Disease Research and the Center for Military Psychiatry and Neuroscience.


News Article | November 7, 2016
Site: www.eurekalert.org

The first of five early stage clinical trials to test the safety and ability of an investigational Zika vaccine candidate called the Zika Purified Inactivated Virus (ZPIV) vaccine to generate an immune system response has begun at the Walter Reed Army Institute of Research (WRAIR) Clinical Trial Center in Silver Spring, Maryland. Scientists with WRAIR, part of the U.S. Department of Defense (DoD), developed the vaccine. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is co-funding the Phase 1 clinical trial with WRAIR, serving as the regulatory sponsor and providing other support. The experimental ZPIV vaccine is based on the same technology WRAIR used in 2009 to successfully develop a vaccine for another flavivirus called Japanese encephalitis. The ZPIV vaccine contains whole Zika virus particles that have been inactivated, meaning that the virus cannot replicate and cause disease in humans. However, the protein shell of the inactivated virus remains intact so it can be recognized by the immune system and evoke an immune response. NIAID partially supported the preclinical development of the ZPIV vaccine candidate, including safety testing and non-human primate studies that found that the vaccine induced antibodies that neutralized the virus and protected the animals from disease when they were challenged with Zika virus. WRAIR, NIAID and the Biomedical Advanced Research and Development Authority (BARDA) part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) have established a joint Research Collaboration Agreement to support the development of this vaccine. "We urgently need a safe and effective vaccine to protect people from Zika virus infection as the virus continues to spread and cause serious public health consequences, particularly for pregnant women and their babies," said NIAID Director Anthony S. Fauci, M.D. "We are pleased to be part of the collaborative effort to advance this promising candidate vaccine into clinical trials." Led by WRAIR principal investigator Maj. Leyi Lin, M.D., the new study aims to enroll 75 people ages 18 to 49 years with no prior flavivirus infection. Flaviviruses include Zika virus, yellow fever virus, dengue virus, Japanese encephalitis virus and West Nile virus. Participants will be randomly divided into three groups: the first group (25 participants) will receive two intramuscular injections of the ZPIV test vaccine or a placebo (saline) 28 days apart; the other two groups (25 participants each) will receive a two-dose regimen of a Japanese encephalitis virus vaccine or one dose of a yellow fever vaccine before beginning the two-dose ZPIV vaccine regimen. Investigators chose to administer additional flavivirus vaccines because U.S. service members are often vaccinated against these diseases before deploying to Zika-endemic areas. Additionally, a subgroup of 30 of the participants who receive the two-dose ZPIV regimen will receive a third dose one year later. All participants in the trial will receive the same ZPIV dose at each injection (5 micrograms). A DoD Research Monitor, an independent physician not associated with the protocol, will monitor the conduct of the trial and report any safety issues to the WRAIR Institutional Review Board. Another independent group, the Safety Monitoring Committee, will also monitor participant safety, review data and report any issues to NIAID. As the regulatory sponsor, NIAID ensures the trial follows the study protocol and informs the FDA of any significant adverse events or risks. NIAID also maintains the Investigational New Drug (IND) application for the candidate vaccine. The WRAIR study is expected to be completed by fall 2018. Four additional Phase 1 studies to evaluate the ZPIV investigational vaccine are expected to launch in the coming months. These include BARDA is funding the advanced development of the ZPIV vaccine candidate through a six-year contract with Sanofi Pasteur, which established a collaborative research and development agreement with WRAIR to accelerate further development of the 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 website. 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. .


News Article | November 9, 2016
Site: www.biosciencetechnology.com

On Monday scientists began a Phase 1 human clinical trial to test safety and immunogenicity, or the ability to provoke an immune response, of the Zika purified inactivated virus (ZPIV) vaccine. The study, supported by the National Institutes of Health’s National Institute of Allergy and Infectious Disease will vaccinate 75 healthy adults. Zika is a flavivirus that is transmitted primarily by the Ades mosquitos and causes rashes and mild fevers in adults.  It has also been linked to birth defects such as microcephaly. Scientists from the Walter Reed Army Institute of Research will first vaccinate some volunteers against other similar flaviviruses, such as yellow fever, before administering the ZPIV vaccine. Preclinical studies showed that ZPIV was successful in protecting rhesus monkeys against two strains of the Zika virus. “The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and built the case for subsequent efficacy trials,” Col. Nelson Michael, director of WRAIR’s Military HIV Research Program and Zika program co-lead said in a prepared statement. “All of this was done in 10 months.” The new vaccine candidate was established at the beginning of 2016 using the same technology used to develop the Japanese encephalitis vaccine. Sanofi Pasteur recently entered into a cooperative research and development agreement with the Army to obtain the ZPIV technology so that it can invest in larger scale manufacturing and to further develop the vaccine. The Army is invested in this research not only because troops are deployed to areas where Zika virus is a cause for concern, but also because many members of the military are concentrated in U.S. southern states where Zika transmission is more common. According to a news release, since the beginning of November there were 149 confirmed Zika virus cases in the military health system. Principal investigator of the study, Maj. Leyi Lin said that Zika infections can lead to severe birth defects and neurological issues and that a proven Zika vaccine is a global public health priority. In addition to the current study, three other Phase 1 trials will test ZPIV this year.  Scientists from St. Louis University will investigate ideal dosing to be used in further studies, while researchers from Harvard Medical School and Beth Israel Deaconess Medical Center will examine the immune response and safety of a compressed vaccine schedule. There will also be a trial to test ZPIV’s immunogenicity and safety in patients who have already been infected with the Zika virus.

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