Chikungunya has been in U.S. since at least 2014.
The University of Iowa is one of three sites in the United States that will be enrolling participants for a clinical trial of an experimental vaccine for a debilitating inflammatory virus called chikungunya.
Researchers will enroll healthy adult volunteers to participate in the Phase 1/2 trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is being conducted at several NIAID-funded Vaccine and Treatment Evaluation Units. The experimental vaccine was developed by Themis Bioscience of Vienna, Austria.
Chikungunya virus has been endemic in East Africa at least since it was first discovered in the 1950s. Chikungunya arrived in the Caribbean in late 2013, and has affected more than 2 million people in the Americas as of March 2017, according to the World Health Organization (WHO).
Although chikungunya is rarely fatal, the mosquito-transmitted virus causes an intense inflammatory reaction resulting in severe joint pain, fever, rash, and muscle pain. While most symptoms usually resolve in days, the joint inflammation can linger.
"This is a very important trial. Chikungunya virus is circulating widely around the world and causes debilitating symptoms in people who develop the infection,” says Patricia Winokur, MD, executive dean of UI Carver College of Medicine. “The United States has already had small numbers of infections in Florida in 2014 and we have the right mosquitoes in many states so this infection could spread. This trial is an important step in trying to develop an effective vaccine.
Winokur, who is also director of the Vaccine and Treatment Evaluation Unit at UI, is principal investigator and is leading the clinical trial.
The new Phase 1/2 vaccine study will enroll 180 healthy adults ages 18 to 45 at three sites: the University of Iowa; Baylor College of Medicine in Houston, Texas; and Emory University in Atlanta, Georgia. The study will evaluate two dose levels of the MV-CHIKV vaccine and each participant will receive two injections. Clinic staff will follow up with study participants by phone and during clinic visits over the course of eight to 13 months to monitor for any adverse reactions or safety issues. The participants will provide blood samples to be analyzed for evidence of antibody production, which would indicate that the vaccine is prompting an immune response.
A 2014 Phase 1 trial of the MV-CHIKV vaccine conducted in Austria by Themis Bioscience showed that the experimental vaccine is safe and induces an immune response. The company is currently conducting a Phase 2 trial in Europe with the same vaccine. The candidate vaccine is a measles vaccine virus modified to produce chikungunya virus proteins. Once inside a human cell, the vaccine induces the production of both measles and chikungunya proteins. The immune system then develops antibodies against those proteins, which may protect the vaccinated person from future infection by chikungunya virus. The vaccine virus does not cause measles or chikungunya disease.
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