Invivyd (IVVD) Study result summary

Study design

• Phase III randomized, double-blind, active-controlled LIBERTY enrolled 210 healthy adults aged 18–49 in 1:1:1 arms: 250 mg VYD2311, COMIRNATY, or both; no placebo arm.

• Co-primary safety and tolerability endpoints covered the first 6 days; secondary endpoints covered 56 days.

• LIBERTY was not designed to compare VYD2311 with placebo or establish clinical efficacy; monotherapy immunogenicity findings were preliminary and underpowered.

Safety and tolerability

• At day 6, 56.5% of VYD2311 recipients versus 91.4% of mRNA-vaccine recipients had any TEAE, ISR, or hypersensitivity (P<0.0001); over 56 days, rates were 60.9% versus 83.1% (P<0.0001).

• Systemic adverse events at day 6 were 44.1% with VYD2311 versus 68.1% with mRNA vaccination (P=0.008).

• No VYD2311-related adverse events exceeded Grade 2; no hypersensitivity, anaphylaxis, myocarditis, or pericarditis occurred in any arm.

• The combination arm had numerically fewer adverse events and fewer systemic events than mRNA vaccine alone.

Immunogenicity

• Co-administration increased total neutralizing titers by ~2.5x versus vaccine alone over 56 days.

• After VYD2311 was removed from combination-arm samples, vaccine-induced neutralization curves matched those from vaccine alone, showing no detected immunologic interference.

• LIBERTY lacked clinical correlates to translate vaccine titers into efficacy estimates and was not intended as an efficacy read-through to DECLARATION.