NIAID-sponsored trial of experimental chikungunya vaccine begins

Faith Castro
June 6, 2017

The candidate vaccine, MV-CHIKV, was developed by Themis Bioscience of Vienna, Austria.

An experimental vaccine for chikungunya - a mosquito-borne virus sometimes mistaken for Zika - is beginning clinical trials at three sites in the USA, the National Institutes of Health announced Monday.

Baylor is now recruiting healthy adults between the ages of 18 to 49 years living in the Houston area who do not plan on traveling to the areas where chikungunya now is being transmitted during the time period of the study, which will take place over the next six to nine months.

Chikungunya fever is a viral infection transmitted by mosquitoes, which is marked by severe joint pain accompanied by fever and headache. While most symptoms usually resolve in days, the joint inflammation can linger.

Chikungunya virus has been endemic in East Africa since at least the 1950s, when it was first discovered. It circulates in monkeys and sometimes humans.

In October 2016, the company announced that it completed the pre-clinical studies on one of the two Zika virus vaccine candidates it had developed in-house.

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Since its appearance in the Western Hemisphere in late 2013, cases of chikungunya have soared, and within the last three years, well over 1.5M cases have been reported in the Americas and the Caribbean alone, highlighting the urgent need for an affordable prophylactic vaccine. "A vaccine to prevent infection with this virus would be of considerable benefit to people living in the more than 60 countries where chikungunya transmission has occurred, as well as travelers to those countries". The three sites are part of the NIAID-funded Vaccine and Treatment Evaluation Units.

Hyderabad-based vaccine manufacturer Bharat Biotech has said the first phase of human clinical trials of Chikungunya vaccine are underway to evaluate it's safety, tolerance and immunogenicity. Participants will receive two injections of either a low dose or high dose of the experimental vaccine or placebo, the NIH said. The results will help determine the best dosage and timing for the vaccine. Neither the participants nor the investigators will know whether a volunteer is receiving placebo or investigational vaccine.

The research team will follow up with study participants by phone and during clinic visits over 8 to 13 months to monitor for any adverse reactions.

In March, the NIH announced the beginning of Phase II testing for a Zika vaccine, enrolling close to 2,500 participants who received a non-infectious version of the virus, meant to stimulate the body's immune response.

Themis Bioscience is now conducting a Phase 2 trial in Europe with the same vaccine candidate.

For more information about the MK-CHIKV vaccine study, see www.clinicaltrials.gov using the identifier NCT03028441.

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