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COVID-19 mRNA vaccine · 1 trial · 1 indication
To compare the systemic reaction of VYD2311 (study drug) with a COVID-19 vaccine when administered alone or concurrently in healthy adults. E-diaries will solicit participant reported systemic reactions including vomiting, fever, diarrhea, headache, fatigue, chills, myalgia, and arthralgia.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections | ACTIVE_COMPARATOR | Treatment Arm 1: A COVID-19 vaccine administered by IM injection and placebo administered by IM injection in separate locations |
| Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections | ACTIVE_COMPARATOR | Treatment Arm 2: VYD2311 250 mg administered by IM injection and placebo administered by IM injection in separate locations |
| Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections | ACTIVE_COMPARATOR | Treatment Arm 3: VYD2311 250 mg and a COVID-19 vaccine adminstered as two IM injections in separate locations |
| Name | Type | Description |
|---|---|---|
| COVID-19 mRNA vaccine | DRUG | A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection. |
| VYD2311 | DRUG | A one-time dose of VYD2311 250mg will be administered by intramuscular injection. |
| Placebo (Normal Saline) | DRUG | A one-time dose of normal saline (placebo) administered by intramuscular injection. |
Inclusion Criteria: 1. Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening 2. Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive. 3. Is in good health, with no clinically significant abnormalities as determined by the Investigat...
VYD2311 is an investigational COVID-19 mRNA vaccine being developed for the prevention of COVID-19. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The vaccine is designed to elicit serum virus neutralizing antibody responses against COVID-19.
VYD2311 is being developed by Invivyd, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IVVD. The company is conducting a Phase 3 clinical trial to evaluate the safety and immunogenicity of VYD2311 as a COVID-19 vaccine.
VYD2311 is currently in Phase 3 clinical development. It is an investigational COVID-19 vaccine and has not been approved by the FDA or any other regulatory authority. The ongoing Phase 3 trial is actively recruiting participants in the United States.
VYD2311 is being evaluated in a Phase 3 clinical trial registered as NCT07655180. This randomized, double-blind, active-controlled study is assessing the safety and serum virus neutralizing antibody responses of VYD2311, both alone and coadministered with another COVID-19 vaccine. The trial is recruiting 210 healthy adult participants aged 18 years and older in the United States.
VYD2311 is a specific COVID-19 mRNA vaccine candidate developed by Invivyd, Inc. It is distinct from other mRNA vaccines, such as those from Pfizer-BioNTech or Moderna. VYD2311 is being studied as a standalone vaccine and in combination with another COVID-19 vaccine in a Phase 3 trial.