Invivyd has received advice from the US Food and Drug Administration (FDA) and is aligned with it on the LIBERTY Phase III trial, which will compare the immunologic and safety profile of VYD2311, an investigational monoclonal antibody, to messenger RNA (mRNA) Covid vaccines.
The trial will also evaluate the effects of simultaneous administration of VYD2311 and an mRNA vaccine.
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The Phase III double-blind, randomised trial will assess serum virus-neutralising antibody responses, pharmacokinetics, and safety of VYD2311, an mRNA vaccine, and their co-administration in 210 participants.
Data from the US Centers for Disease Control and Prevention (CDC) showed that concerns about serious or unknown side effects remain a principal reason some Americans have not received Covid booster shots in the 2023-2024 season.
Due to the known risk of myocarditis/pericarditis among young adults using mRNA vaccines, the FDA has specifically requested Invivyd monitor for these adverse events in LIBERTY, which includes an mRNA vaccine arm.
Invivyd’s DECLARATION study, a Phase III biologics license application-enabling trial for VYD2311, continues in parallel.
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By GlobalDataThis placebo-controlled, triple-blind, randomised study will enrol 1,770 participants, including adults and adolescents both with and without risk factors, to assess VYD2311’s efficacy in preventing symptomatic Covid at three months.
They will receive either a single or a monthly intramuscular dose versus a placebo. Top line data are expected by mid-2026.
Invivyd board of directors chairman Marc Elia said: “The LIBERTY trial is intended to build on the placebo-controlled DECLARATION trial of VYD2311, and is designed to provide an exploratory look at the potential improvement in safety and tolerability associated with monoclonal antibody-mediated prophylaxis compared to mRNA-based vaccine control.”
mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
