Development of a Monoclonal Antibody for the Prevention and Treatment of Zika Virus Infection
Abstract
Topic Areas Addressed: The overarching goal of this program is to develop a drug that treats and protects against Zika virus (ZIKV) infection and the birth defects associated with ZIK) infection during pregnancy (Congenital Zika Syndrome or CZS). This proposal addresses the “Vaccine Development for Infectious Diseases” topic area and the following Areas of Encouragement: development of a therapeutic vaccine and/or other strategies for infectious diseases; development and fielding of vaccines to prevent Service members from becoming ill from endemic disease exposure during operational deployments (includes Zika); and evaluation of passive immunization strategies to use in conjunction with vaccines. The Need for Protection Against Zika Virus Infection. ZIKV is an emerging mosquito-transmitted virus that can cause severe disease, most notably CZS, which is a distinct pattern of birth defects characterized by small head size, characteristic brain anomalies, eye developmental anomalies, and poor muscle control leading to lifelong disability. ZIKV infection during pregnancy can lead to CZS in 7% of ZIKV infection and up to 13% if infection occurs during the first 12 weeks of pregnancy. ZIKV is currently circulating in Africa and Asia and recently spread to the Americas with a highly publicized outbreak in Brazil that led to over 200,000 suspected ZIKV infection cases and nearly 3,000 cases of CZS. The United Nations Development Programme (UNDP) estimated that the short-term costs of the recent Zika epidemic are $7 billon to $18 billion, with long-term costs for CZS estimated at an additional $8 billion. Service members are most likely to encounter ZIKV during deployment to areas with circulating ZIKV. The immediate effects of ZIKV infection are not usually life-threatening, but symptoms may last for several days to a week, which could impact Service members’ ability to perform important tasks. ZIKV infections can also go undetected and can be sexually transmitted, which puts partners at risk upon return from deployments. Of most concern is the risk of transmitting ZIKV to pregnant women. There other groups who may be at risk for ZIKV infection and would benefit from a drug to protect against ZIKV infection such as aid workers, travelers, and healthcare workers. ZIKV outbreaks occur periodically, and large numbers of people need an option for protection against ZIKV infection and prevention of CZS. The Product: Our technology leverages our own immune systems to protect against ZIKV infection through the identification of molecules called antibodies from the blood of survivors of ZIKV infection. We can use these antibodies to prevent and treat ZIKV infection in others. We then modify the antibodies to improve safety and increase the length of time that the drug protects against ZIKV infection. We have also taken the initial steps in establishing commercial-grade drug manufacturing processes. Impact of Proposed Project: In the proposed project, we will advance development of a drug that protects against and treats ZIKV infection. We will complete the development of the drug manufacturing processes and produce quantities of the drug to perform several important experiments. We will determine the dose of drug required to prevent ZIKV infection. We will also do studies to test for toxicity and understand how long the drug is present in the bloodstream after administration. The information from these studies will prepare us for the next phases of development: non-human primate studies, testing in humans, and eventual approval by the U.S. Food and Drug Administration (FDA). Once approved, we envision that this product could be administered to Service members prior to or shortly after deployment to areas with circulating ZIKV or ongoing ZIKV outbreak. A single injection in the arm could prevent ZIKV infection for up to 6 months. Broader applications include travelers to regions with circulating ZIKV or heal
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910405
Entities
People
- Charles Haines
Organizations
- United States Army