NCT06028841

A Clinical Phase 3 Trial of VLA1553 in Adult Participants with Human Immunodeficiency Virus (HIV)

An Open-label Phase 3 Trial to Assess the Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine (VLA1553) in Moderately Immunocompromised Adult Participants Infected with Human Immunodeficiency Virus

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a phase 3 clinical study to evaluate the safety, tolerability, and immunogenicity of VLA1553 in moderately immunocompromised adults with HIV infection.

Detailed description

This was a multicenter, prospective, open-label, uncontrolled, single arm, phase 3 clinical study evaluating the final dose of VLA1553. The safety, tolerability, and immunogenicity of VLA1553 should have been assessed in moderately immunocompromised adult participants infected with HIV living in CHIKV endemic areas. Approximately 75 male and female adults (aged 18 years or above) infected with HIV should have been enrolled. Participants would have been screened by ELISA for evidence of previous CHIKV exposure excluding CHIKV seropositive participants from study participation.

Conditions

• Chikungunya Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	VLA1553	Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose

Timeline

• Start date: 2024-04-10
• Primary completion: 2024-08-27
• Completion: 2024-08-27
• First posted: 2023-09-08
• Last updated: 2024-12-02

Regulatory

• FDA-regulated drug study