VLA1601 / Emergent Biosolutions, Valneva - LARVOL DELTA

Effects of candidate vaccines against Zika virus infection: A systematic review of the clinical trials. (PubMed, Vaccine) - "ZIKV vaccine candidates across diverse technological platforms are safe and highly immunogenic. The evidence of long-term durability and the success of single-dose or mRNA regimens support the progression of the most promising candidates to Phase 2/3 trials."

Journal • Review • Fatigue • Infectious Disease • Pain

VLA1601-102: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults (clinicaltrials.gov) - P1 | N=150 | Completed | Sponsor: Valneva Austria GmbH | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

VLA1601-102: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: Valneva Austria GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Apr 2026 | Trial primary completion date: Jul 2025 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook (GlobeNewswire) - "Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023); Key Upcoming Catalysts...Lyme disease Phase 3 first data readout by the end of 2025; Further chikungunya vaccine approvals, including the first endemic country (Brazil) and adolescent label extensions for IXCHIQ in major travel markets; Initiation of Phase 3 pediatric trial of IXCHIQ to support further potential label expansion; Phase 2b efficacy data from Human Challenge Study (CHIM) of tetravalent Shigella vaccine candidate in mid-2025 and launch of pediatric study; Phase 1 results for Zika vaccine candidate in the first half of 2025"

Commercial • New trial • P1 data • P3 data • Chikungunya • Infectious Disease • Lyme Disease

VLA1601-102: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Valneva Austria GmbH | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Infectious Disease

Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Valneva Austria GmbH

New P1 trial • Infectious Disease

Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults (clinicaltrials.gov) - P1; N=67; Completed; Sponsor: Valneva Austria GmbH; Active, not recruiting ➔ Completed

Trial completion • Biosimilar