VYD2311 for Coronavirus Prevention
(DECLARATION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug called VYD2311 to determine its effectiveness in preventing COVID-19. VYD2311 is a monoclonal antibody designed to attach to the virus and prevent it from entering cells. Participants will receive shots of either VYD2311 or a placebo (a harmless substitute) to help researchers evaluate its efficacy and safety. The trial seeks individuals aged 12 and up who have not recently had COVID-19 and have not been exposed to the virus in the past few days. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that VYD2311, a monoclonal antibody, is being tested to prevent COVID-19. Studies have found it generally safe for healthy individuals. Earlier research reported no major safety issues for the multiple-dose version. Similarly, current data suggests the single-dose version is also safe.
Previous trials of VYD2311 showed it was developed from another antibody with a good safety record, providing some confidence in its safety. However, the current trial remains crucial to confirm these findings and ensure VYD2311's safety for a broader population.
In summary, both versions of VYD2311 appear safe and well-tolerated so far, but ongoing trials will offer more detailed information about any possible side effects.12345Why do researchers think this study treatment might be promising?
Researchers are excited about VYD2311 for coronavirus prevention because it offers a new approach to fighting the virus. Unlike current vaccines, which typically require two doses for full efficacy, VYD2311 is being tested in both single-dose and multi-dose formats, providing flexible options for administration. This treatment is administered via intramuscular injection, making it similar to existing vaccines but potentially offering different dosing schedules that could simplify logistics and improve accessibility. Additionally, the study of a multidose regimen may lead to longer-lasting protection, which is a significant advantage over some current options.
What evidence suggests that VYD2311 might be an effective treatment for COVID-19 prevention?
Research shows that VYD2311, a type of protein, might help prevent COVID-19 by binding to the virus and blocking its entry into cells. Studies on similar proteins have shown they might reduce COVID-19 infections. In this trial, participants will receive either a single dose or multiple doses of VYD2311, or a placebo. Early results suggest that even one dose could offer strong protection for up to three months. Although more results are pending, the mechanism and early findings appear promising for preventing COVID-19.12346
Are You a Good Fit for This Trial?
This trial is for healthy adults and adolescents at least 12 years old to test VYD2311, a drug aimed at preventing COVID-19. Participants will receive either the investigational drug or a placebo via injection once a month for three months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VYD2311 or placebo via IM injection on Day 1, Day 30, and Day 60
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VYD2311
Trial Overview
VYD2311, an experimental monoclonal antibody designed to block the virus causing COVID-19 from entering cells, is being tested against a placebo. The study assesses its effectiveness in prevention over 90 days and examines safety, body processing, immune response, and virus neutralization.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
VYD2311 administered via IM injection on Day 1, Day 30, and Day 60
VYD2311 administered via IM injection on Day 1, followed by placebo injection (0.9% sodium chloride \[normal saline\]) on Day 30 and Day 60
Normal saline administered by IM injection on Day 1, Day 30, and Day 60
Find a Clinic Near You
Who Is Running the Clinical Trial?
Invivyd, Inc.
Lead Sponsor
Citations
Study of VYD2311 for the Prevention of COVID-19
This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot.
2.
investors.invivyd.com
investors.invivyd.com/news-releases/news-release-details/invivyd-earns-fast-track-designation-vyd2311-vaccine-alternativeInvivyd Earns Fast Track Designation for VYD2311, a ...
Top-line data from the trial are expected mid-2026. DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate ...
3.
reaganudall.org
reaganudall.org/clinical-trial/study-investigational-monoclonal-antibody-vyd2311-healthy-participantsA Study of the Investigational Monoclonal Antibody ...
A study to investigate the safety, tolerability, and pharmacokinetics of aSARS-CoV-2-directed monoclonal antibody in healthy participants.
Invivyd Doses First Participants in Phase 1 Clinical Trial of ...
VYD2311 was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically ...
VYD2311 for Coronavirus Prevention (DECLARATION Trial)
The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19.
Study of VYD2311 for the Prevention of COVID-19
This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot.
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