CIR Team FIRE Prepares to Conduct their First In-Human Zika Investigational Vaccine Trial
CIR’s Team FIRE (Flavirus Immunization Research and Education) led by Dr. Anna Durbin, is gearing up to start their first Investigational Zika vaccine (ZIKV) clinical trial. The vaccine is a live attenuated chimeric vaccine meant to prevent Zika infection by inducing a protective immune response.
Zika is a mosquito-borne flavivirus that is mostly spread by Aedes aegypti and Aedes albopictus mosquitos. The virus can also be transmitted from an infected pregnant woman to her fetus, and through sex. It can cause fever, rash, headache, joint pain, red eyes and muscle pain and can last for several days to a week. Zika made international news in 2015 when an outbreak in Brazil led to an association between Zika virus infection and Guillain-Barré Syndrome (GBS), as well as an association between Zika virus infection and microcephaly. In 2016, the links between Zika infection and neurological disorders led the World Health Organization (WHO) to declare this issue a Public Health Emergency of International Concern. Since then, scientists, researchers and public health officials have been working vigorously to identify and implement procedures to prevent the spread of the disease, including Zika vaccine development.
Dr. Anna Durbin, Johns Hopkins Bloomberg School of Public Health professor has been conducting investigational vaccine research trials at the CIR for flaviviruses like Dengue and West Nile since 1999. She has worked closely with Dr. Stephen Whitehead at the NIH National Institute of Allergy and Infectious Diseases (NIAID) and many other distinguished colleagues including the CIR’s Director Dr. Ruth Karron to explore Zika vaccine development.
Currently, a ZIKV candidate is identified and will be tested in a Phase 1 study at Johns Hopkins Center for Immunization Research and at the University of Vermont College of Medicine. The study will enroll 28 subjects who receive one dose of the investigational ZIKV or placebo. The subjects will be followed for 26 weeks to evaluate safety, reactogenicity, and immunogenicity of the vaccine. Healthy men and women between the ages of 18-50 who are flavivirus-naive and meet all inclusion/exclusion criteria will be enrolled. Screening for this study is underway and enrollment is scheduled to begin September 2018.
Researchers hope to move forward with a ZIKV controlled human infection model (CHIM) to fully evaluate the efficacy of an immunogenic ZIKV.