As the race to develop the world's first Chikungunya vaccine continues, two biotechs kicked off tests for their respective programs on Monday. Sponsored by the National Institutes of Health, Austria's Themis Bioscience started a phase 2 trial on its candidate in the U.S., just as Indian vaccine maker Bharat Biotech advanced its program into human testing.
For Themis, the NIH will sponsor a 180-person trial at contracted Vaccine and Treatment Evaluation Units at the University of Iowa, the Baylor College of Medicine and the Emory University. There, researchers will seek to verify whether the vaccine—under two different dosages—can induce neutralizing antibodies and a T-cell response.
In a previous phase 1 study, investigators detected antibodies against the virus in all vaccinated participants after a second dose. Last August, Themis advanced the shot into phase 2 in Europe.
At the same time, the biotech is collaborating with the Walter Reed Army Institute of Research to study the live attenuated vaccine in a previously epidemic area. The U.S. Army also has its own candidate currently under development and has tapped Engility to help with clinical projects.
For Bharat, a phase 1 trial in India will enroll 60 volunteers to test the shot's safety and whether it can trigger an immune response. The Drug Controller General of India approved the test based on solid preclinical data, the company said.
India is one of several countries plagued by Chikungunya, notably by a major outbreak in 2006. Bharat’s candidate targets the virus that caused that outbreak, as well as another Asian genotype isolated in 1963. Another serious outbreak hit Delhi last summer.
Besides India, Chikungunya has been identified in over 60 countries in Asia, Africa, Europe and the Americas, according to the World Health Organization. A major outbreak hit the Americas in 2015, the year that Texas documented the first local transmission in the U.S. A majority of cases in the U.S. were travel-related, however.