Business
Invivyd Announces Initiation of DECLARATION Clinical Trial, a Phase 3 Placebo-Controlled Pivotal Study of VYD2311, a Vaccine-Alternative Antibody to Prevent COVID
DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of COVID versus placebo, at three months, from a single intramuscular (IM) dose, with protection beyond three months anticipated A second arm will evaluate monthly IM doses versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons seek periodic extra protection from COVIDPrimary endpoint is
About this update from Invivyd, Inc.
[{"type":"image","alt":"Invivyd","displaySize":"","headline":null,"caption":"Invivyd","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":44,"url":"https://media.zenfs.com/en/globenewswire.com/4a4d9d450de79e16fc0a485fff104ca6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/MyR5b2vdhRgALtKrzLKLAQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTYyO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/4a4d9d450de79e16fc0a485fff104ca6","width":300,"height":44}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of COVID versus placebo, at three months, from a single intramuscular (IM) dose, with protection beyond three months anticipated","length":265,"tagName":"p"}]},{"val":[{"type":"text","content":"A second arm will evaluate monthly IM doses versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons seek periodic extra protection from COVID","length":215,"tagName":"p"}]},{"val":[{"type":"text","content":"Primary endpoint is the reduction of PCR-confirmed symptomatic COVID incidence versus placebo; total expected enrollment of 1770 people across all three arms","length":157,"tagName":"p"}]},{"val":[{"type":"text","content":"DECLARATION is part of the Company’s REVOLUTION clinical program aimed at establishing monoclonal antibody prophylaxis for prevention of COVID; top-line data are expected mid-2026","length":179,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":816,"olType":false},{"type":"text","content":"NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced initiation of the DECLARATION trial evaluating VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID. DECLARATION is the company’s Biologics License Application (BLA)-enabling, Phase 3 randomized, triple-blind, placebo-controlled clinical trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents.","length":540,"tagName":"p"},{"type":"text","content":"The DECLARATION study will evaluate prevention of symptomatic COVID at three months, with either a si...