NCT04838444

Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)

An Open-Label, Single Arm Trial To Evaluate Antibody Persistence And Long Term Safety Of A Live-Attenuated Chikungunya Virus Vaccine (VLA1553) In Adults Aged 18 Years and Above

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).

Detailed description

In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724) These participants will have annual follow-up visits at Months 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 after immunization. The primary objective of this trial will be to evaluate persistence of antibodies annually from 1 to 10 years after the single immunization with VLA1553. The secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with VLA1553.

Conditions

• Chikungunya Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	VLA1553	Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity.

Timeline

• Start date: 2021-04-02
• Primary completion: 2025-12-01
• Completion: 2031-05-01
• First posted: 2021-04-09
• Last updated: 2025-12-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study