Chikungunya Vaccine Candidate Advances into Phase 1 Second Stage
Valneva VLA1553′s Phase 1 clinical trial study participants now being re-vaccinated
A single-shot vaccine candidate against the Chikungunya viral disease announced progress in its Phase 1 program targeting.
This is important news since there is not an FDA-approved Chikungunya vaccine.
Valneva SE’s VLA1553′s Phase 1 clinical trial is a randomized, observer-blinded, dose-escalation, multi-center study, investigating 3 different dose levels in approximately 120 healthy adults vaccinated with a single-shot immunization.
The first group of study participants is now being re-vaccinated, according to a Valneva press release.
This re-vaccination will act as an intrinsic human challenge, with the goal of demonstrating that subjects are protected from vaccine-induced viremia early in the VLA1553 clinical development.
VLA1553 aims for long-lasting protection and an anticipated safety profile similar to licensed vaccines for active immunization in adults and children.
The target population segments are travelers, military personnel and individuals at risk living in endemic regions.
Valneva said it now expects to announce initial data from this trial in early 2019.
Previously, during pre-clinical development, a single-vaccine shot was shown to be highly immunogenic in vaccinated Non-Human Primates and showed no signs of viremia after challenge, with a good safety profile.
Chikungunya is a viral disease transmitted by the bite of infected mosquitoes such as Aedes aegypti and Aedes albopictus. It can cause high fever, joint, and muscle pain, and headache says, the World Health Organization (WHO).
Chikungunya virus causes clinical illness in 72-92% of infected humans around 4 to 7 days after an infected mosquito bite.
Chikungunya does not often result in death, but the joint pain may last for months or years and may become a cause of chronic pain and disability.
Since 2013, Chikungunya transmissions have been identified in 45 countries or territories throughout the Americas. More than 1.7 million suspected cases reported to the Pan American Health Organization from affected areas.
As of October 16, 2018, a total of 65 chikungunya virus disease cases with illness onset in 2018 from 21 U.S. states. All reported cases occurred in travelers returning from affected areas. No locally-transmitted cases have been reported from U.S. states.
Valneva SE travel vaccine portfolio includes:
- Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
- VALNEVA Announces Progress of Chikungunya Vaccine Candidate
- Valneva Announces Progress of Chikungunya Vaccine Candidate
- Chikungunya Virus Vaccine Candidate Enters Clinical Study