Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects

NCT03014089 ↗

Phase 1 Completed 90 enrolled ModernaTX, Inc. Biomedical Advanced Research and Development Authority · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.

Timeline

Start: 2016-12-21
Primary completion: 2019-07-31
Completion: 2019-07-31

Outcome

Missed primary endpoint

paper Safety was the primary outcome of each study reads as unknown PMID 36682364 ↗

paper These were descriptive studies, with no formal hypothesis testing in either trial. reads as unknown PMID 36682364 ↗

release “While the vaccine was well tolerated, the immunogenicity endpoint at doses up to 100µg has not been met.” reads as missed primary endpoint modernatx.com ↗

Publications

Essink B, Chu L, Seger W, Barranco E, Le Cam N, Bennett H, Faughnan V, Pajon R, Paila YD, Bollman B, Wang S, Dooley J, Kalidindi S, Leav B. 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. Lancet Infect Dis. 2023 May;23(5):621-633. doi: 10.1016/S1473-3099(22)00764-2. Epub 2023 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mRNA-1325	Messenger RNA (mRNA)	10 ug	—
Subject	mRNA-1325	Messenger RNA (mRNA)	25 ug	—
Subject	mRNA-1325	Messenger RNA (mRNA)	100 ug	—