FHI 360's clinical trials expertise supports further development of a Zika virus vaccine
FHI 360 is providing monitoring services for a randomized, placebo-controlled trial to evaluate the safety, immunogenicity and efficacy of a DNA vaccine for the Zika virus that could protect healthy adults and adolescents from acquiring the debilitating virus. The study, funded by the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health, will enroll more than 2,490 healthy adults and adolescents who live in potential endemic regions in the Caribbean, Central and South America and the United States.
The study, A Phase 2/2B, Randomized Trial to Evaluate the Safety, Immunogenicity and Efficacy of a Zika Virus DNA Vaccine in Healthy Adults and Adolescents, will be conducted at more than 20 sites.
Under a contract with the Emmes Corporation, FHI 360's clinical research associates will monitor the sites to ensure they are compliant with guidelines and regulations and to verify that data has been collected according to the approved protocol. FHI 360 will also assist in ensuring vaccine accountability, which includes overseeing its storage, use and disposal.
In the last few years, the Zika virus has reemerged as a serious global public health threat. The virus, which can cause congenital Zika syndrome and Guillain-Barre syndrome — a debilitating disorder — has spread rapidly throughout the Americas. Most frequently, the Zika virus is transmitted by an infected Aedes aegypti mosquito, which also spreads the dengue and chikungunya viruses. The Zika virus can also be transmitted during pregnancy and through sexual contact.
FHI 360 has decades of experience in designing, implementing and monitoring international clinical trials, managing global research networks and building clinical site capacity in resource-constrained settings, where rapid work to address health crises is critical. Research for the Zika vaccine is one of many studies FHI 360 supports in the field of infectious and parasitic diseases and in response to disease outbreaks.