Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial
Saint-Herblain (France), April 12, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial, VLA1553-301, of its single-shot chikungunya vaccine candidate, VLA1553. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV) 1.
A total of 4,131 adults aged 18 or above have been recruited across 44 sites in the US for the pivotal Phase 3 trial, VLA1553-301, which was launched in September 20202. If the trial results are positive, the trial is expected to support VLA1553’s licensure.
The primary endpoint of the double-blinded, placebo-controlled study is to demonstrate safety and immunogenicity 28 days after a single-shot vaccination with VLA1553 including a subset of
participants (immunogenicity subset) tested for sero-protection based on an immunological surrogate agreed with the Food and Drug Administration (FDA). Participants will be followed for six months
in the pivotal trial. On April 1st 2021, Valneva also initiated an antibody persistence trial, VLA1553-303, that will follow the immunogenicity subset for a period of five years.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are extremely pleased to have reached this important milestone despite the ongoing COVID-19 pandemic affecting many people worldwide and creating challenges for recruitment into clinical trials. Chikungunya virus is a major, growing public health threat and we are looking forward to our top line data in mid-2021. We would like to thank everyone involved, we could not have achieved this important milestone without hard work and dedication”.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia. As of September 2020, there were more than 3 million reported cases in the Americas3 and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.