Valneva has reported initial safety data from the Phase III VLA1553-321 trial evaluating the vaccine candidate VLA1553 in adolescents with chikungunya.
The pivotal, multicentre, placebo-controlled, randomised, double-blinded, prospective study is carried out in partnership with Instituto Butantan.
It is intended to support label extension in adolescent patients aged 12 to 17 years age group.
Funds for the study were provided by the Coalition for Epidemic Preparedness Innovations in Oslo, Norway.
A total of 754 adolescents from endemic area who were previously infected with chikungunya virus (CHIKV) were randomised into 2:1 ratio to receive a single dose of VLA1553 intramuscularly, and placebo.
Evaluating the safety and immunogenicity of the adult dose of VLA1553 28 days following a single vaccination is the primary objective of the study.
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Secondary objectives include assessment of the same parameters up to 12 months.
VLA1553 was found to be generally safe and well tolerated in adolescents.
Valneva chief medical officer Juan Carlos Jaramillo said: “These new safety data in a younger population and in individuals previously infected with the chikungunya virus confirm the safety profile we previously observed in adults and the elderly.
“Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus is endemic, it is therefore our objective to make this vaccine available to all age groups, especially as no vaccine or specific treatments are currently available for this debilitating disease.”
Immunogenicity data from the trial is anticipated in November this year.
The safety data from the trial is also anticipated to support licensure of the vaccine in Brazil. It is claimed to be the first potential approval for use in endemic populations.
Valneva is also planning to use the data for regulatory submission to the European Medicines Agency later this year.
The FDA has provided a prescription drug user fee act date of end of November this year for Valneva’s biologic license application of VLA1553.
In addition, the company filed a regulatory application seeking approval for the CHIKV vaccine from Health Canada.