mRNA-1893 / Moderna - LARVOL DELTA

Safety and immunogenicity of mRNA Zika virus vaccine: Result from Phase 2 Trial of mRNA-1893 (ASTMH 2024) - "Overall, both 30 μg and 100 μg doses and the dosing regimens (1-dose 100 μg vs 2-dose 30 μg, and 2-dose 100 μg) were well-tolerated. A single dose may be sufficient to generate a robust immune response in baseline flavivirus positive participants while a two-dose regimen is likely needed to elicit robust immune response in baseline flavivirus negative participants."

Clinical • P2 data • Infectious Disease

A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas (clinicaltrials.gov) - P2 | N=808 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

An optimized messenger RNA vaccine candidate protects non-human primates from Zika virus infection. (PubMed, NPJ Vaccines) - "Herein, we compared the immune responses following mRNA-1325 and mRNA-1893 vaccination and reported that mRNA-1893 generated comparable neutralizing antibody titers to mRNA-1325 at 1/20th of the dose and provided complete protection from ZIKV challenge in non-human primates. In-depth characterization of these vaccines indicated that the observed immunologic differences could be attributed to a single amino acid residue difference that compromised mRNA-1325 virus-like particle formation."

Journal • Infectious Disease

The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. (PubMed, Lancet Infect Dis) - P1 | "These findings support the continued development of mRNA-1893 against Zika virus, which was well tolerated at all evaluated dose levels and induced strong Zika virus-specific serum nAb responses after two doses, regardless of baseline flavivirus serostatus."

Journal • P1 data • Infectious Disease

A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas (clinicaltrials.gov) - P2 | N=809 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Sep 2023 ➔ Feb 2024 | Trial primary completion date: Sep 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Infectious Disease

A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas (clinicaltrials.gov) - P2; N=800; Recruiting; Sponsor: ModernaTX, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas (clinicaltrials.gov) - P2; N=800; Not yet recruiting; Sponsor: ModernaTX, Inc.

Clinical • New P2 trial • Infectious Disease